Acologix Presents Data On Cartilage Regeneration By AC-100 At The 56th Annual Meeting Of The Orthopaedic Research Society

Acologix, Inc., a privately held biopharmaceutical company, announced the results of its latest preclinical study demonstrating that AC-100, its therapeutic product candidate derived from an endogenous human protein, promotes cartilage regeneration in a large animal model. The data will be presented by Dr. David M. Rosen on March 6, 2010 at the 56th annual meeting of the ORS (Orthopaedic Research Society) in New Orleans, LA.


The effects of AC-100 on cartilage regeneration were evaluated in goats with standardized defects in knee cartilage. Four weekly intra-articular injections of AC-100 or placebo were administered. Quantity and quality of cartilage regeneration were evaluated after six months.


AC-100 dose dependently promoted cartilage repair compared to placebo. Furthermore, the new cartilage formed in response to AC-100 was mature, normal hyaline cartilage as assessed by several histological staining methods. Similar to previous studies, AC-100 exhibited a favorable safety profile in this study, with no inflammatory response.


"These results showing normal cartilage regeneration with AC-100 strongly support our excitement for this program, and we are looking forward to initiating clinical trials in osteoarthritis and traumatic cartilage injury," said Dr. Dawn McGuire, Chief Medical Officer of Acologix. "The previously demonstrated ability of AC-100 to promote regeneration of underlying damaged bone makes the use of AC-100 a unique approach for repair and regeneration of hard tissue in OA, RA, and traumatic injury."


Acologix, Inc.


Acologix, Inc. a privately held biopharmaceutical company, is developing and commercializing novel biopharmaceuticals targeting osteo-renal indications, including the complications with chronic kidney disease and dialysis, bone and cartilage repair and regeneration, and general dental and oral care. The company's most advanced program, AC-820 is at the Phase 3 stage in the U.S. and was approved for sale in Japan in January of 2009 for the treatment of uremic pruritus in dialysis patients. The second program, AC-100, a hard tissue growth promoting molecule, has been studied in two Phase II clinical studies and demonstrated high safety profile and selective hard tissue formation activities in dental restoration procedures. Further studies have revealed that AC-100 also selectively promotes bone and cartilage repair and regeneration. Acologix is also developing AC-200 (Phosphatonin) to treat bone loss associated with chronic kidney disease.


Abstract Number 974 "AC-100 Promotes Cartilage Defect Repair in Vivo and Chondrocyte Differentiation and Function in Vitro" by Catherine Middleton-Hardie, Ph.D. and David Rosen, Ph.D. of Acologix, Harold Aberman, D.V.M., Tim Simon, Ph.D. of Applied Biological Concepts, and Tamara Alliston, Ph.D. and Ashton Mortazavi, Ph.D. from the Department of Orthopedic Surgery, University of California, San Francisco. Presented as Poster #974 by Dr. David Rosen on Saturday, March 6, 2010, at the 56th Annual Meeting of the Orthopedic Research Society in New Orleans, LA.


This press release contains "forward-looking" statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. Acologix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Acologix' business.

Scottsdale Healthcare-TGen Clinical Trial Results Signal Advances Against Skin Cancer

Analyses of clinical trial results published in the New England Journal of Medicine (NEJM) shows a potential new investigational therapy for advanced and metastatic basal cell skin cancer.



The study, conducted at TGen Clinical Research Service (TCRS) at Scottsdale Healthcare and two other sites appears to demonstrate tumor shrinkage and limited side effects. TCRS is a strategic alliance between the Translational Genomics Research Institute (TGen) and Scottsdale Healthcare.



These findings are significant because no proven therapy exists for advanced basal cell carcinoma (BCC). BCC is the most common cancer in the United States with about one million new cases diagnosed each year. Arizona has one of the highest incidences of skin cancer in the world.



The article appears on-line today and in the Sept. 17 print issue of NEJM.



"Until now, no treatment existed that effectively slowed tumor growth in those patients with advanced skin cancer," said lead investigator Daniel D. Von Hoff, MD, Physician in Chief at TGen, Chief Medical Officer for the Scottsdale Clinical Research Institute at Scottsdale Healthcare and chief scientific officer at US Oncology. "By strategically initiating what we call "precision oncology", or using the right drug for each cancer, this study offers great potential against basal cell carcinoma and other cancers."



The trial, sponsored by Genentech, included clinicians at TCRS, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, and Karmanos Cancer Institute in Detroit. The results demonstrated that GDC-0449, a Hedgehog Pathway Inhibitor, appears to shrink tumors in locally advanced and metastatic BCC. Known as the "Hedgehog" trial, the clinicians observed a durable clinical benefit - defined as tumor shrinkage visible on X-ray or other physical exam or improvement in symptoms without tumor growth - in 18 of 33 patients evaluated. Others had stable disease for prolonged periods of time. Only 4 patients had progression of disease.



Abnormal activation of the Hedgehog signaling pathway appears to be an important mechanism for numerous types of cancer to develop, survive, or grow. A chemical called cyclopamine found in the California corn lily can inactivate this Hedgehog pathway.



Study investigators selected BCC as the first cancer to study in that most BCCs have abnormalities or mutations of Hedgehog pathway genes named PATCHED and SMOOTHENED.



"Success of this new therapy is another example of applying genetic information to medicine. We are constantly working to improve treatment options for patients with common and rare cancers," said TCRS physician Glen J. Weiss, M.D., a contributing author on the study.



Patient response to the therapy was assessed through physical examination and imaging.



"Integrating genomic data with state-of-the-art clinical and imaging information to develop and apply targeted therapies has certainly taken a major step forward with the encouraging results from the Hedgehog trial," added Dr. Ron Korn, a Scottsdale Healthcare radiologist and director of Scottsdale Medical Imaging Ltd.



Initial observation and isolation of cyclopamine from the corn lily occurred in 1957. Subsequently, scientists at Genentech developed GDC-0449 (an oral drug), which was jointly validated through a series of preclinical studies performed under a collaboration agreement between Genentech and Curis, Inc. (Cambridge, MA). Genentech is a wholly owned subsidiary of the Roche Group.

Randomized Controlled Clinical Trial Shows Derma Sciences MEDIHONEY(TM) Eradicates MRSA From Chronic Venous Ulcers

Derma Sciences (OTC
Bulletin Board: DSCI), a provider of advanced wound care products,
announced that its key product, MEDIHONEY(TM) Wound & Burn Dressing
with Active Leptospermum Honey, has been found in a large randomized
controlled clinical trial to significantly reduce the presence of
methicillin-resistant Staphylococcus aureus (MRSA) in chronic wounds. The
finding was published in the June 2008 issue of The Journal of Wound Care.



MRSA continues to dominate global headlines as a formidable
hospital-acquired infection, killing thousands of patients each year and
becoming a huge burden on healthcare costs. The number of hospital
admissions for MRSA has increased rapidly over the last decade, with a 300%
increase in 2005 over that of 2000, and a 1000% increase over that of 1995.
Conservative estimates suggest a global figure of up to 53 million people
carrying MRSA. The bacteria is resistant to such common antibiotics as
methicillin, amoxicillin, penicillin, and oxacillin, and is quick to adapt
to new ones. Historically, MRSA has been most common among people with weak
immune systems living in either hospitals or long-term care centers.
However, it has been increasingly present in healthy people, giving rise to
community-acquired MRSA.



Commenting on the publication, CEO Ed Quilty stated, "This study was
presented last year at the European Wound Management Association, and we
are pleased that the work has been recognized in such a well-regarded peer
reviewed wound care journal serving the global market. MRSA, which is now
reaching out beyond the walls of hospitals and nursing homes into the
general community, claims more lives than AIDS in certain countries.
MEDIHONEY's ability to eradicate this superbug, while also helping chronic
wounds to progress towards healing, makes it a truly unique product in the
field of wound care. We, along with our global commercialization partner
Comvita, have seen steady growth in interest and sales in the product line
since its launch."



The trial, a 108-patient randomized and controlled clinical trial,
looked at venous leg ulcers that had been proven to be non-healing under
standard treatment (compression therapy). In the study, half the patients
had a common advanced wound care gel added to the standard treatment, and
half had Comvita's Active Leptospermum (Manuka) Honey (now marketed under
the brand name MEDIHONEY(TM)) added. After four weeks, 70% of the MEDIHONEY
treated wounds versus only 16% of the hydrogel treated wounds had MRSA
eradicated.



Published in this month's Journal of Wound Care, the research paper
"Bacteriological Changes in Sloughy Venous Leg Ulcers Treated with Manuka
Honey or Hydrogel: an RCT," was written by lead investigators Georgina T.
Gethin and Seamus Cowman, both of the Royal College of Surgeons in Ireland.
They concluded that for sloughy venous ulcers, "the efficacy of honey in
eliminating MRSA in such wounds is a positive finding that may have
implications for wound management and infection control."
















Wound care is a major healthcare market with an estimated value of $10
billion in 2007, and is predicted to grow to $12.5 billion in 2012. The
global double-digit growth is being driven by several factors, including an
aging population, the rise in the global incidence of diabetes and chronic
vascular disorders, and a steady advancement in wound care technologies.
The advanced wound care segment encompasses a wide range of disparate
technologies that includes dressings and other devices. The three main
categories for dressings are: Traditional wound care such as gauze, moist
wound dressings designed to manage basic moisture issues, and active
dressings which incorporate technologies that provide additional benefits
such as antimicrobial activity. The active category is the fastest growing
among the three. A recent market research report by Kalorama Information
details the emergence of honey-based dressings as a growing sub-category
within active dressings.



About Derma Sciences



Derma Sciences is a global manufacturer and marketer of advanced
wound-care products. Its key product, MEDIHONEY, is sold throughout the
world by Derma Sciences and Comvita New Zealand -- the licensor of the
patented honey-based technology -- and is the leading brand of honey-based
dressings for the management of wounds and burns. The product has been
shown to be effective in a variety of wounds and burns, and was recently
the focus of a large-scale randomized controlled trial on leg ulcers. Derma
has two products in development: the NIMBUS technology based line of
barrier gauze dressings, and DSC127, the company's novel angiotensin analog
for accelerated wound healing and scar reduction. The barrier technology
was licensed from Quick-Med in Q1 of 2007 and is pending its initial FDA
marketing clearance. DSC127 was licensed from The University of Southern
California in Q4 of 2007 and is entering into a Phase II study, with
anticipated initial patient enrollment to begin in Q3 of 2008. For more
information about Derma Sciences, Inc., visit its home page on the Internet
at dermasciences.



About the Journal of Wound Care (JWC)



JWC is the definitive wound-care journal and the leading source of
tissue viability research and clinical information. Launched in 1992, it is
designed to meet the needs of the multidisciplinary team. The journal is
essential reading for all wound-care specialists - nurses, doctors and
researchers -- who are keen to keep up-to-date with all developments in
wound management and tissue viability, but also appeals to generalists
wishing to enhance their practice. JWC is internationally renowned for its
cutting edge and state-of-the-art research and practice articles. The
journal also covers management, education and novel therapies. Articles are
rigorously peer- reviewed by a panel of international experts.
journalofwoundcare.


Derma Sciences

dermasciences

Scholar In Perinatal Bioethics Honoured By March Of Dimes

Examining the ethical issues of involving pregnant women in research trials is the focus of the work of the 2010 March of Dimes Young Scholar Award in Perinatal Bioethics recipient.



The March of Dimes honored Anna R. Brandon, PhD, MS, for her work at the annual American Society for Bioethics and Humanities at the Hilton San Diego Bayfront.



Dr. Brandon, who received her doctorate in clinical psychology and master's degree in clinical science at the University of Texas Southwestern Medical Center in Dallas, is working to improve research guidelines so women will have access to appropriate care during their pregnancies.



Dr. Brandon was recognized for her paper: Ethical Barriers to Perinatal Mental Health Research and Evidence Based Treatment: An Empirical Study. She examined the challenges researchers face when they attempt to study mental health illness in pregnant women. Without such research, pregnant women may lack access to beneficial medication and evidence -based treatment.



"Pregnant women need to be included and involved in medical research because they need to know the real outcomes of taking medicine and how it will affect their child before and after birth," said Dr. Brandon.



Alan R. Fleischman, MD, March of Dimes senior vice president and medical director, presented the award.



"Pregnant women often are not included in research trials because of the fear of the consequences to the unborn baby," said Dr. Fleischman. "Dr. Brandon's research creates an ethical framework for involving pregnant women so we can gather the data needed to develop pregnancy-specific guidelines for prescribing medications, giving women access to safe and effective treatment during pregnancy and improving the health of mothers and babies."

TAU Develops Dissolving Dressing For Wounds Packed With Infection-Fighting Antibiotics

Despite advances in treatment regimens and the best efforts of nurses and doctors, about 70% of all people with severe burns die from related infections. But a revolutionary new wound dressing developed at Tel Aviv University could cut that number dramatically.



Prof. Meital Zilberman of TAU's Department of Biomedical Engineering has developed a new wound dressing based on fibers she engineered - fibers that can be loaded with drugs like antibiotics to speed up the healing process, and then dissolve when they've done their job. A study published in the Journal of Biomedical Materials Research - Applied Biomaterials demonstrates that, after only two days, this dressing can eradicate infection-causing bacteria.



The new dressing protects the wound until it is no longer needed, after which it melts away. "We've developed the first wound dressing that both releases antibiotic drugs and biodegrades in a controlled manner," says Prof. Zilberman. "It solves current mechanical and physical limitations in wound-dressing techniques and gives physicians a new and more effective platform for treating burns and bedsores."



Not as simple as it sounds



While the concept is simple, the technology is not. Skin, Prof. Zilberman explains, serves a number of vastly different purposes. "Wound dressings must maintain a certain level of moisture while acting as a shield," she says. "Like skin, they must also enable fluids from the wound to leave the infected tissue at a certain rate. It can't be too fast or too slow. If too fast, the wound will dry out and it won't heal properly. If too slow, there's a real risk of increased contamination."



Prof. Zilberman's new wound dressing, which does not yet have a formal name, is designed to mimic skin and the way it protects the body. It combines positive mechanical and physical properties with what medical researchers call "a desired release profile of antibiotics."



Slashing mortality statistics



Unlike oral antibiotics, locally-applied antibiotics can target and kill harmful bacteria before they enter the body to cause further infection, sepsis, or death. "People who suffer from large burns don't usually die from the condition itself. The fatal culprits are the secondary bacterial infections that invade the body through these vulnerable burned areas," says Prof. Zilberman.



The new TAU dressing inhibits bacterial growth and is biodegradable, which helps doctors avoid constant wound cleaning and redressing, allowing the body to do the work on its own. "When administered at the wound, a doctor can give relatively high but local doses of antibiotics, avoiding any toxicity issues that arise when the same amount of antibiotic passes through the body," explains Prof. Zilberman, who worked on this research with Jonathan Elsner, her Ph.D. student.



Prof. Zilberman is now starting the early stages of clinical trials on animal models. So far, her wound dressing has passed physical and mechanical tests in vitro and in bacterial inhibition tests in the laboratory. She is also seeking a strategic partner to co-develop the research and take it to the commercial stage.

Shire Reports Positive Efficacy And Safety Results From FAST-3 Study Of Firazyr® (icatibant) For Acute Attacks Of Hereditary Angioedema

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced topline results from FAST-3 (For Angioedema Subcutaneous Treatment), the largest of the Phase III trials studying the use of Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema (HAE).


The study showed that patients receiving treatment with Firazyr experienced a significantly faster time to onset of symptom relief from individual and combined cutaneous and abdominal HAE symptoms, compared to those receiving placebo.


Firazyr provided a highly statistically significant and clinically meaningful benefit relative to placebo for the primary endpoint of time to onset of symptom relief for the first attack after study enrollment. This was measured by a 50% reduction in a composite symptom score assessed by the patient. The median time to onset of symptom relief for Firazyr by this measure was 2.0 hours, compared with 19.8 hours for placebo.


Firazyr also provided a significantly shorter time to onset of symptom relief of the patient's primary (main) symptom. This secondary efficacy endpoint was measured by a 30% reduction in symptom score. The median time to onset of relief for Firazyr by this measure was 1.5 hours, compared with 18.5 hours for placebo.


The results for both of these endpoints were highly statistically significant (p

A Lack In Research And Effective Treatments For Body Dysmorphic Disorder

Medication and psychotherapy may be beneficial for patients suffering from body dysmorphic disorder (BDD). But a new Cochrane Review found that much more research is required to determine the most effective treatment and whether both approaches should be used in combination.



Body dysmorphic disorder affects as many as one in 20 people. Patients suffering from BDD worry obsessively about their physical appearance, with concerns frequently but not exclusively focused on the skin, hair and nose, and often have very low levels of self-esteem. Many are also diagnosed with depression and around a quarter may attempt suicide. According to Cochrane Researchers, however, there is currently very little evidence regarding the relative effectiveness of drug treatment and psychotherapy approaches.



"Given the number of people suffering from BDD and the level of distress caused, it is surprising that so little data is available on treatments. This is certainly a field that deserves additional attention and funding," said lead researcher, Jonathan Ipser, who works at the MRC Research Unit for Anxiety and Stress Disorders at the University of Stellenbosch, South Africa.



Ipser and colleagues carried out a systematic review of currently available evidence, analysing data from four trials, which together included 169 patients. They found that over half of people treated in a single trial with the antidepressant fluoxetine for 12 weeks showed improvement, compared to less than a quarter of those given a placebo. And in two 12 week trials of cognitive behavioural therapy (CBT), symptom severity was significantly reduced. Both types of treatment were well tolerated, with no severe adverse effects reported.



"Both approaches seem to be acceptable to patients with this condition, as shown by low drop-out rates in trials. There was also some suggestion that psychotherapy could reduce the risk of future relapse, although we need more data on long term treatment effects to confirm this," said Ipser.

ERBITUX(R) Meets Primary Endpoint Of Increasing Survival In Phase III Lung Cancer Study

ImClone Systems
Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY)
today announced that a Phase III study of ERBITUX(R) (Cetuximab) in
combination with platinum-based chemotherapy (vinorelbine plus cisplatin)
met its primary endpoint of increasing overall survival compared with
chemotherapy alone in patients with advanced non-small cell lung cancer
(NSCLC). This large, randomized multi-national study, known as FLEX
(First-Line Treatment for Patients with Epidermal growth factor inhibitor
(EGFR)-EXpressing Advanced NSCLC) was conducted by Merck KGaA, Darmstadt,
Germany and enrolled patients with Stage IIIB or Stage IV NSCLC who had not
previously received chemotherapy.



"Based on the FLEX results, ERBITUX is the only member of the class of
epidermal growth factor inhibitors to demonstrate survival in the
first-line treatment of patients with advanced non-small cell lung cancer.
Previous pivotal trials involving other agents targeting EGFR have failed
to demonstrate a survival advantage for these patients," stated Eric K.
Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone
Systems. "These are important results for lung cancer patients and health
care professionals treating this devastating disease, since there have been
very few treatment advances for lung cancer in recent years."



"Studies have shown that ERBITUX improves overall survival for patients
with certain head and neck cancers, and now, with the FLEX data, for
patients with advanced non-small cell lung cancer," said Martin Birkhofer,
M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers
Squibb. "We look forward to sharing these data with the medical community."



Results from this study will be submitted for presentation at an
upcoming medical conference.



Merck KGaA, Darmstadt, Germany, is ImClone Systems' ERBITUX partner
outside of North America.



About Lung Cancer



The American Cancer Society estimates that in the U.S., more than
213,000 people will be diagnosed with lung cancer in 2007. Lung cancer is
the leading cause of cancer-related death in men and women in the U.S.,
with 160,000 deaths estimated in 2007. Approximately 80 to 85% of these
patients will be diagnosed with non-small cell lung cancer, with the
majority being diagnosed with locally advanced or metastatic disease.



About ERBITUX(R) (Cetuximab)



ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the
function of a molecular structure expressed on the surface of normal and
tumor cells called the epidermal growth factor receptor (EGFR, HER1,
c-ErbB-1). In vitro assays and in vivo animal studies have shown that
binding of ERBITUX to the EGFR blocks phosphorylation and activation of
receptor-associated kinases, resulting in inhibition of cell growth,
induction of apoptosis, and decreased matrix metalloproteinase and vascular
endothelial growth factor production. In vitro, ERBITUX can mediate
antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor
types. While the mechanism of ERBITUX's anti-tumor effect(s) in vivo is
unknown, all of these processes may contribute to the overall therapeutic
effect of ERBITUX. EGFR is part of a signaling pathway that is linked to
the growth and development of many human cancers, including those of the
head and neck, colon and rectum.
















ERBITUX (Cetuximab), in combination with radiation therapy, is
indicated for the treatment of locally or regionally advanced squamous cell
carcinoma of the head and neck. ERBITUX as a single agent is indicated for
the treatment of patients with recurrent or metastatic squamous cell
carcinoma of the head and neck for whom prior platinum-based therapy has
failed.



ERBITUX is indicated for the treatment of EGFR-expressing, metastatic
colorectal carcinoma (mCRC) in combination with irinotecan for patients who
are refractory to irinotecan-based chemotherapy, and as a single agent for
patients who are intolerant to irinotecan-based therapy. The effectiveness
of ERBITUX for the treatment of EGFR-expressing mCRC cancer is based on
objective response rates. Currently, no data are available that demonstrate
an improvement in disease-related symptoms or increased survival with
ERBITUX for the treatment of EGFR-expressing mCRC.



For full prescribing information, including boxed WARNINGS regarding
infusion reactions and cardiopulmonary arrest, visit
ERBITUX.



Important Safety Information



Grade 3/4 infusion reactions, rarely with fatal outcome (

TargeGen Announces Initiation Of Clinical Trial Of JAK2 Inhibitor TG101348 In Myeloproliferative Disease Patients

TargeGen, Inc. announced that
the Company has started a multi-center Phase I/II clinical trial of
TG101348, an oral, potent, and highly selective inhibitor of JAK2 in
patients with myeloproliferative diseases.


The V617F mutation of JAK2 is implicated in the pathogenesis of certain
myeloproliferative diseases, including polycythemia vera (PV), essential
thrombocytopenia (ET) and primary myelofibrosis (PMF). In preclinical
models of myeloproliferative diseases, TG101348, administered orally, was
shown to reduce V617F-expressing cell populations in a dose-dependant
manner without adversely impacting normal hematopoeisis. The reduction of
V617F-expressing cell populations correlated with improved survival and
reduced morbidity. There are no currently approved specific therapies for
PV, ET and PMF. These disorders are estimated to affect approximately
200,000 patients in the United States and more than twice that total
worldwide.



The current clinical trial is being conducted at multiple centers in
the USA. The trial is expected to enroll between 40-80 patients. Primary
goals of this open label dose escalating protocol include identification of
a maximum tolerated dose (MTD), accumulation of safety data, measurement of
drug effect on surrogate markers, biomarkers, and presumptive clinical
endpoints.



About TargeGen, Inc.



TargeGen, Inc. is a privately held vascular biology-focused
biopharmaceutical company based in San Diego, CA. TargeGen primarily
develops small molecule kinase inhibitors that target vascular leakage
(edema), vascular proliferation (angiogenesis) and inflammation. Edema,
angiogenesis and inflammation are involved in the pathology of many major
human diseases.



TargeGen initiated operations in 2002 and has raised capital from top
tier venture capital sources. Current investors include VantagePoint
Venture Partners, Forward Ventures, Enterprise Partners, Chicago Growth
Partners, BB BIOTECH VENTURES, Innovis Investments, H&Q Capital Management,
Pappas Ventures, CTI Life Sciences and other investors.


TargeGen, Inc.

targegen

Cordis Corporation Starts Pivotal Trial For ExoSeal(TM) Vascular Closure Device

Cordis Corporation, a
worldwide leader in developing and manufacturing interventional vascular
technology, announced today the start of the pivotal trial for the
ExoSeal(TM) Vascular Closure Device. The ECLIPSE Trial is a multicenter,
non-blinded, randomized study designed to measure the safety and efficacy
of the ExoSeal(TM) Vascular Closure Device versus manual compression to
close vascular access sites in patients having undergone diagnostic or
interventional procedures. The trial will encompass 400 patients from 18
medical centers across the United States.


On February 13, Principal Investigator Chiu Wong, M.D., Associate
Professor of Medicine, New York-Presbyterian Hospital/Weill Cornell Medical
Center and a Cordis Corporation Consultant, treated the first patient in
the trial. Prior to the start of the ECLIPSE Trial, the ExoSeal(TM)
Vascular Closure Device had been used in 150 patients participating in a
first-in-human study for the device.



"The results from the first-in-man study were very encouraging, and
this trial will help us determine whether those results can be maintained
in a larger number of patients," said Dr. Wong. "As an interventional
cardiologist, I welcome the opportunity to investigate a device that could
help patients recover faster from a catheterization procedure."



The ExoSeal(TM) Vascular Closure Device features a synthetic
bioabsorbable polymer and is being studied to determine whether it can
enable expedited hemostasis (the cessation of bleeding), faster patient
ambulation (ability to walk) and reduced bed-stay after a catheterization
procedure. It also represents Cordis' entry into the vascular closure
device market. Nearly eight million patients undergo cardiac
catheterization procedures annually.



"The swift progress of the ExoSeal(TM) Vascular Closure Device from the
proof-of-concept stage to a pivotal trial in only seven months marks a
major milestone in Cordis' efforts to accelerate the development of new
devices to improve the treatment of vascular diseases," said Campbell
Rogers, M.D., Chief Technology Officer, Cordis Corporation. "The ECLIPSE
Trial will help us evaluate whether the ExoSeal(TM) Vascular Closure Device
could make a significant and positive difference in patients' comfort as
well as recovery time following a catheterization procedure."



Catheterization procedures involve the temporary insertion of a
catheter into an artery, usually the femoral artery, through a vascular
puncture. While a variety of methods, such as manual compression, sandbags
and mechanical clamps have been used to close the puncture site and stop
the bleeding after the catheter is removed, many of these methods cause
significant discomfort and require several hours of bed-rest.



About Cordis Corporation



Cordis Corporation, a Johnson & Johnson company, is a worldwide leader
in developing and manufacturing interventional vascular technology. Through
the company's innovation, research and development, physicians worldwide
are better able to treat the millions of patients who suffer from vascular
disease. For more information, visit cordis.


Cordis Corporation

cordis

Promising Results From 2 Trials Highlighting Pomalidomide Presented At ASH

Celgene International Sarl (Nasdaq: CELG) has announced that its next IMiDs compound, pomalidomide, has shown promising activity with manageable safety and tolerability for the treatment of relapsed/refractory multiple myeloma (MM) and myelofibrosis. The data were presented at the 50th Annual American Society of Hematology meeting in San Francisco, CA.



Early analysis of the Phase II MM study, in which half of the 60 patients with relapsed MM received combined low-dose dexamethasone with pomalidomide, showed that 76 percent of the patients experienced disease improvement or stabilization. Another key finding showed a 29 percent response rate among patients who previously did not respond to REVLIMID® therapy. Objective response was achieved by 58 percent of patients. Eight of the 60 patients had dose reductions. The most commonly occurring major adverse events were neutropenia (32%), thrombocytopenia (3%) and anemia (3%). Investigators concluded that for most patients, pomalidomide plus low-dose dexamethasone was generally well tolerated with manageable adverse events. However, there was one patient death due to pneumonia while neutropenic in this refractory, pre-treated population.



The study's conclusion was that pomalidomide was highly active in this segment of multiple myeloma patients.



The second Phase II trial, evaluating 84 patients with advanced myelofibrosis with myeloid metaplasia, was a four-arm blinded adaptive design trial. The study evaluated two different doses of pomalidomide with or without prednisone, with a prednisone-only arm as a control. All but one patient had failed prior therapies. The Grade 2 or greater side effects were infrequent and comparable to the prednisone control except for thrombocytopenia that was experienced in one of 22 patients and one of 19 patients treated with 2 mg of pomalidomide with or without prednisone. Thirty-five percent of the treated pomalidomide patients experienced blood cell transfusion independence. At the time of this presentation, 15 of the 16 responders remain in remission. Granulocytopenia and normal spleen size correlated with response, but the percent of abnormal cytogenetics and the presence of a JAK2 mutation did not.



"The interest in our next IMiDs compound, pomalidomide, by the hematological community was demonstrated by both clinical abstracts being selected for oral presentations at the annual meeting of the American Society of Hematology," stated Jerome B. Zeldis, Chief Medical Officer, Celgene Corporation. "Based on these findings and others, Celgene will be developing pomalidomide for relapsed multiple myeloma and other hematological conditions."




















About Pomalidomide



Pomalidomide is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. These immunomodulatory agents, taken orally, have unique multiple mechanisms of action that involve the microenvironment of the cancer cell, not just the malignant cell itself. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions.



About Multiple Myeloma



Multiple myeloma is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. Most patients with multiple myeloma, however, have cells that produce a form of immunoglobulin called paraprotein (or M protein), which does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.



About Myelofibrosis



Myelofibrosis with myeloid dysplasia is often referred to as a chronic form of leukemia. It is a serious bone marrow disorder that begins in stem cells that form blood cells. Too few red cells are produced with an overproduction of white cells and platelets. That in turn results in a buildup of collagen in the bone marrow cavity, causing extensive scarring. The results are anemia, fatigue and susceptibility to infection.



About Celgene International Sarl



Celgene International Sarl, located in Boudry, in the Canton of Neuchatel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at celgene.



This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.

Acambis Is First Company To Test A West Nile Virus Vaccine In Older Adults

Acambis plc (Acambis) (LSE: ACM) announces that
clinical testing of its investigational West Nile virus vaccine,
ChimeriVax(TM)-West Nile, is underway in older adults, those most in need
of protection against West Nile virus infection. Acambis' ChimeriVax-West
Nile is the most advanced West Nile virus vaccine in development and the
first to be tested in older adults.


According to the Centers for Disease Control and Prevention, people
over the age of 50 are more likely to develop serious symptoms from West
Nile virus infection; however, individuals of all ages living in areas
where West Nile virus has been identified are at risk. West Nile virus
continues to be a high-profile problem in the US, causing 4,256 cases and
165 deaths in 2006. This is a more than 41% increase in the number of cases
and 38% increase in deaths compared with 2005.



Acambis' Chief Executive Officer Gordon Cameron commented: "The
significant increase in the number of cases and deaths from West Nile virus
last year reinforces the need for a protective human vaccine. Acambis is
the leader in developing a West Nile virus vaccine and we've taken another
important step by testing ChimerVax-West Nile in older adults, the group
most at risk of severe disease from West Nile virus infection."



The trial is designed to evaluate the safety, tolerability and
immunogenicity of ChimeriVax-West Nile in older adults and is being
conducted in the US. The randomised, double-blind, placebo-controlled study
is the second part of a Phase 2 trial evaluating the vaccine.



Previously, Acambis announced encouraging results from the first part
of the Phase 2 trial, which involved younger adults aged 18-40 years. Over
97% of subjects who received a single dose of ChimeriVax-West Nile
developed neutralising antibodies above the predefined cut-off level 28
days after vaccination. The majority of adverse events were mild in nature.



ChimeriVax-West Nile is being developed to provide a safe, single-dose
West Nile virus vaccine for at-risk individuals. There is currently no
human vaccine against this disease so efforts to reduce the incidence of
infection revolve around preventive measures to protect against mosquito
bites, the cause of nearly all human infections of the virus.



While the majority of West Nile infections are mild and asymptomatic,
approximately 20% of those infected will develop symptoms such as fever,
headache, body aches and swollen glands. The more severe West Nile
encephalitis is estimated to occur in one out of every 150 infections.
Symptoms include high fever, neck stiffness, stupor, convulsions, coma and
sometimes paralysis. Death can occur in the most severe cases when the
virus crosses the blood-brain barrier, leading to encephalitis or
inflammation of the brain.
















Since the West Nile virus emerged in the US in 1999, there have been
almost 24,000 cases and 946 deaths.



About ChimeriVax-West Nile



- ChimeriVax-West Nile is being developed to provide a safe,
single-dose West Nile virus vaccine for those at risk from the virus.




- Development of Acambis' investigational vaccine, ChimeriVax-West
Nile, was supported by a $3m grant from the US National Institutes of
Health.



- It is a live, attenuated, injectable vaccine and was developed using
Acambis' proprietary ChimeriVax(TM) technology, which was developed in
association with St Louis University.



- The level of immune response required for protection against West
Nile virus is yet to be determined.



About Acambis



Acambis is a leading biotechnology company targeting infectious
diseases with novel vaccines. Acambis' development-stage pipeline includes
vaccines that could either offer improvements over existing products or
target unmet medical needs. As well as ChimeriVax-JE, Acambis' proprietary
ChimeriVax technology has also been used to develop ChimeriVax-West Nile,
which is undergoing Phase 2 clinical testing, making it the most advanced
investigational vaccine against the West Nile virus. Acambis also has the
only vaccine in development against Clostridium difficile bacteria, a
leading cause of hospital-acquired infections. Recognised internationally
as the leading producer of smallpox vaccines, Acambis is developing an
investigational smallpox vaccine, ACAM2000, and is manufacturing
emergency-use stockpiles of this investigational vaccine for the US
Government and other governments around the world.



Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and
is listed on the London Stock Exchange (ACM). More information is available
at acambis/.



"Safe Harbor" statement under the Private Securities Litigation Reform
Act of 1995:



The statements in this news release that are not historical facts are
forward-looking statements that involve risks and uncertainties, including
the timing and results of clinical trials, product development,
manufacturing and commercialisation risks, the risks of satisfying the
regulatory approval process in a timely manner, the need for and the
availability of additional capital. For a discussion of these and other
risks and uncertainties see "Risk management' in the Company's 2005 Annual
Report and "Risk factors' in its Form 20-F, in addition to those detailed
on the Company's website and in the Company's filings made with the
Securities and Exchange Commission from time to time. These forward-looking
statements are based on estimates and assumptions made by the management of
Acambis and are believed to be reasonable, though are inherently uncertain
and difficult to predict. Actual results or experience could differ
materially from the forward-looking statements.


Acambis plc

acambis/

From Fruit Fly Wings To Heart Failure. Why Not(ch)?

Almost a century after it was discovered in fruit flies with notches in their wings, the Notch signalling pathway may come to play an important role in the recovery from heart attacks. In a study published today in Circulation Research, scientists at the European Molecular Biology Laboratory (EMBL) in Monterotondo, Italy, are the first to prove that this signalling pathway targets heart muscle cells and thus reveal its crucial role in heart development and repair.


The Notch pathway is a molecular mechanism through which cells communicate with each other. Scientists in Nadia Rosenthal's group at EMBL used sophisticated genetic mouse models to uncover critical roles for this pathway in heart muscle cells. When they inactivated Notch specifically in the heart muscle precursor cells of early mouse embryos, the scientists discovered that the mice developed heart defects. Curiously, increasing Notch signalling in the heart muscle cells of older embryos had the same detrimental effect, uncovering different requirements for Notch as development proceeds.


"The cardiac malformations we observed are characteristic of Alagille syndrome, a human congenital disorder," said first author Paschalis Kratsios. "Therefore, our findings could help to explain the cardiac symptoms associated with Alagille syndrome and related forms of congenital heart disease."


Intriguingly, the scientists were able to improve the cardiac function and survival rate of adult mice that had suffered heart attacks by re-activating Notch, suggesting new therapeutic approaches to help the heart recover from damage.


"Overall, these results highlight the importance of timing and context in biological communication mechanisms," Nadia Rosenthal concludes: "Our findings also lend support to the notion that, in certain situations, redeployment of embryonic signalling pathways could prove beneficial for tissue regeneration in the adult."

In Patients With Metastatic Prostate Cancer Therapeutic Vaccine Prolongs Survival And Improves Quality Of Life

A new prostate cancer vaccine may give hope to men with metastatic prostate cancer by enabling their immune systems to fight the disease. Researchers from the University of Iowa presented data on the adenovirus/PSA (Ad/PSA) vaccine during the Annual Scientific Meeting of the American Urological Association in Orlando. In recent years, the concept of vaccine immunotherapy for advanced prostate cancer has become increasingly high profile as research has expanded. Major advances in the field have contributed significantly to the discussion of this important cancer therapy as researchers explore new ways to prolong survival and improve the quality of life in patients with metastatic disease.



Researchers present their findings in a special press conference on May 18, 2008 at 2:00 p.m.



Prostate cancer cells produce a protein known as prostate-specific antigen (PSA). The goal of immunotherapy for metastatic disease is to manipulate the body's immune system to identify and destroy these cancer cells throughout the body. The Ad/PSA vaccine was developed by inserting the PSA gene into bacteria and viruses and using immune-stimulatory deoxyribonucleic acid (DNA) to modulate the body's anti-tumor response. Enabling a patient's immune system to produce anti-antigens and attack cancer cells can improve quality of life and extend survival. Earlier studies in mice demonstrated the vaccine's efficacy as it produced strong anti-PSA and, as a result, powerful anti-prostate cancer immunity.



This Phase I clinical trial assessed the performance of the Ad/PSA vaccine in men with measurable metastatic prostate cancer. Patients with D2 or D3 cancers (median age 71, median PSA 128 ng/ml) were treated with one of three dose levels of the vaccine and were followed with physical and clinical chemistry exams at two and three weeks and two, four, eight and 12 months. Median follow up was 12 months and median survival was 18 months.



After receiving the vaccine, at least 40 percent of patients developed immune responses to PSA, with anti-PSA antibodies produced in 42 percent of patients and anti-PSA T-cell responses in 71 percent. 57 percent of patients survived longer than predicted, with doubling time increased in 48 percent. Longest survival was 71 months - nearly six years.







Lubaroff DM, Konety BR, Link BK, Ratliff TL, Madsen T, Williams R: Outcomes from a phase I trial of an adenovirus/PSA vaccine for prostate cancer. J Urol, suppl., 2008; 179: 184, abstract 526.



About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs members and their patients, including UrologyHealth, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.

Enrollment In Amoxicillin PULSYS Phase III Trial Completed

Advancis
Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today
announced that it has completed enrollment in the Company's Amoxicillin
PULSYS Phase III clinical trial for the treatment of
pharyngitis/tonsillitis due to Group A streptococcal infections. Advancis
concluded enrollment with a total of 620 adult/adolescent patients as of
close-of-business May 31, 2006.


Advancis' adult and adolescent pivotal program is designed as a 600-
patient, double-blind, double-dummy, non-inferiority Phase III trial and
began on November 9, 2005. Over the coming weeks, patients will complete
their treatment and follow-up visits, and Advancis and its clinical
research organization will collect and analyze the clinical data. The
Company expects to publicly report top-line results around mid-August 2006.
If the trial is successful, Advancis expects to file a 505(b)(2) New Drug
Application (NDA) with the U.S. Food and Drug Administration for the
product early in the first quarter of 2007.


"We are very pleased to have completed enrollment in our adult and
adolescent Phase III trial on schedule," said Edward M. Rudnic, Ph.D.,
Advancis president and CEO. "We are hopeful that, if successful,
Amoxicillin PULSYS will provide physicians a tool to deliver the
established safety and efficacy of amoxicillin in the first and only
once-daily presentation in the U.S."


Advancis is comparing its Amoxicillin PULSYS dosage form for the
treatment of pharyngitis/tonsillitis in adults delivered in a once-daily,
775 milligram tablet for a period of 10 days to 250 milligrams of
penicillin dosed four times daily, for a total of one gram per day, for 10
days. The primary endpoint for the study is bacterial eradication, as
measured by throat cultures obtained both before and after treatment.


More than 59 million prescriptions for amoxicillin were written in 2005
with total retail sales of approximately $640 million. Amoxicillin is
indicated for a broad range of infections, and is commonly prescribed as a
first-line therapy for common infections such as otitis media (middle ear
infection), pharyngitis (sore throat), and sinusitis (sinus infection).
According to data from IMS Health, a pharmaceutical research company,
approximately one-quarter of amoxicillin prescriptions are written for
pharyngitis, strep throat, and tonsillitis in adults and children.



ABOUT ADVANCIS PHARMACEUTICAL:


Advancis Pharmaceutical Corporation (Nasdaq: AVNC) is a pharmaceutical
company focused on the development and commercialization of anti-infective
drug products that fulfill substantial unmet medical needs in the treatment
of infectious disease. The Company is developing a portfolio of
anti-infective drugs based on its novel biological finding that bacteria
exposed to antibiotics in frontloaded staccato bursts, or "pulses," are
killed more efficiently and effectively than those under standard treatment
regimens. Based on this finding, Advancis has developed a proprietary,
once-a-day pulsatile delivery technology called PULSYS. By examining the
resistance patterns of bacteria and applying its delivery technologies,
Advancis has the potential to redefine infectious disease therapy and
significantly improve drug efficacy, shorten length of therapy, and reduce
drug resistance versus currently available antibacterial products. For more
on Advancis, please visit advancispharm.















This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
statements are based on Advancis' current expectations and assumptions.
These statements are not guarantees of future performance and are subject
to a number of risks and uncertainties that would cause actual results to
differ materially from those anticipated. The words, "believe," "expect,"
"intend," "anticipate," "plan," "hope," and variations of such words, and
similar expressions identify forward-looking statements, but their absence
does not mean that the statement is not forward-looking. Statements in this
announcement that are forward- looking include, but are not limited to,
statements about the Company's future development plans, clinical trials,
and financial results. The actual results realized by Advancis could differ
materially from these forward-looking statements, depending in particular
upon the risks and uncertainties described in the Company's filings with
the Securities and Exchange Commission. These include, without limitation,
risks and uncertainties relating to the Company's financial results and the
ability of the Company to (1) reach profitability, (2) prove that the
preliminary findings for its product candidates are valid, (3) receive
required regulatory approvals, (4) successfully conduct clinical trials in
a timely manner, (5) establish its competitive position for its products,
(6) develop and commercialize products that are superior to existing or
newly developed competitor products, (7) develop products without any
defects, (8) have sufficient capital resources to fund its operations, (9)
protect its intellectual property rights and patents, (10) implement its
sales and marketing strategy, (11) successfully attract and retain
collaborative partners, (12) successfully develop, receive regulatory
approval, and commercialize any new Keflex products, and (13) retain its
senior management and other personnel. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of today's date. Advancis undertakes no
obligation to update or revise the information in this announcement,
whether as a result of new information, future events or circumstances or
otherwise.


Advancis Pharmaceutical Corporation

advancispharm/

Vertex Pharmaceuticals Initiates Phase I Development For VX-770 In Cystic Fibrosis

Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has
initiated a Phase I clinical study for VX-770, a novel, oral drug candidate
that specifically targets a key mechanism underlying cystic fibrosis (CF).
The study will evaluate the safety, tolerability and pharmacokinetics of
escalating single and multiple doses of VX-770 in healthy volunteers, and
also will evaluate single doses of VX-770 in patients with CF. The study is
expected to enroll more than 50 individuals. In March 2006, Vertex and
Cystic Fibrosis Foundation Therapeutics Inc. (CFFT) entered into a
collaboration to accelerate clinical development of VX-770. CFFT is the
nonprofit drug discovery and development affiliate of the Cystic Fibrosis
Foundation. Vertex retains worldwide rights to develop and commercialize
VX-770.


"This first clinical study for VX-770 signifies an important milestone
in the productive collaborative history that we have shared with Vertex in
the discovery of novel CF therapies," said Robert J. Beall, Ph.D.,
President and Chief Executive Officer of the Cystic Fibrosis Foundation and
CFFT. "We believe that compounds such as VX-770 have great potential to
change the course of CF, and we are pleased to support the accelerated
development of VX-770 in early clinical studies."


"VX-770 is the first drug candidate to have emerged from our innovative
CF research efforts, and the initiation of this Phase I study represents an
exciting new stage in the development of this compound," said John Alam,
M.D., Executive Vice President, Medicines Development, and Chief Medical
Officer of Vertex. "Laboratory results for VX-770 have been highly
encouraging and support the initiation of this first clinical study. We
look forward to evaluating VX-770 in both healthy volunteers and patients
with CF in the coming months to determine the next steps for the VX-770
development program."


Study Design


The Phase I study for VX-770 announced today is expected to enroll more
than 50 individuals, including healthy volunteers and patients with CF.
Dosing has been initiated in the first cohort of healthy volunteers, and is
expected to progress to patients with CF later this year. Healthy
volunteers in the Phase I study will receive escalating doses of VX-770 for
treatment durations of up to 14 days, and patients with CF will receive
single doses of VX-770.



Fast Track Designation for VX-770


Vertex also today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation to VX-770. The FDA granted Fast
Track designation to VX-770 for the following reasons:


Cystic fibrosis (CF) is a serious and life-threatening illness in which
mucus plugging, infection, and inflammation in the lungs lead to a
decline in pulmonary function and significant morbidity and mortality.















VX-770 is intended to preserve pulmonary function, decrease morbidity,
and prolong survival in patients with CF by decreasing cycles of mucus
plugging, infection, and inflammation in the lungs.


Under the FDA Modernization Act of 1997, Fast Track designation
indicates that the FDA will facilitate the development and may expedite the
review of a drug if it is intended for the treatment of a serious or
life-threatening condition and demonstrates the potential to address an
unmet medical need for such a condition.


About VX-770


VX-770 was advanced into preclinical development based on a successful
research collaboration with CFFT that incorporated capabilities and
proprietary research from Vertex's San Diego research site. VX-770 may act
to restore the function of the cystic fibrosis transmembrane conductance
regulator (CFTR) protein, the defective cell membrane protein responsible
for the progression of CF. Defects in the CFTR protein affect the transport
of chloride and other ions across cells, and lead to the accumulation of
thick, sticky mucus in the lungs of patients with CF. This mucus fosters
chronic infection and inflammation, and results in irreversible lung
damage. Potentiator compounds such as VX-770 are designed to increase the
probability that the CFTR channel is open, which could result in an
increase in chloride transport across the cell surface in some patients. In
laboratory experiments, using cells from patients with CF where CFTR
proteins are present on the cell surface, VX-770 has restored the gating
activity of defective CFTR channels.


Collaborative History with CFFT



Vertex initiated its CF research program in May 2000 in collaboration
with CFFT, which offers special expertise and experience in CF drug
discovery and development. Vertex and CFFT expanded the agreement in May
2004, and in March 2006, entered into a new collaboration for the
accelerated development of VX- 770. Under the collaboration, CFFT will
provide to Vertex approximately $13.3 million to support clinical
development of VX-770 through the fourth quarter of 2007. In addition to
the development collaboration for VX-770, in January 2006, Vertex and CFFT
entered into an expanded research collaboration to discover novel compounds
known as correctors, which may work by increasing the number of CFTR
channels on the cell surface. To date, CFFT has provided to Vertex more
than $40 million for CF research.


About Cystic Fibrosis and the Cystic Fibrosis Foundation


Cystic fibrosis is a genetic disease affecting approximately 30,000
people in the United States. A defect in the CFTR gene causes the body to
produce abnormally thick, sticky mucus that leads to chronic,
life-threatening lung infections and impairs digestion. When the CF
Foundation was established in 1955, few children lived to attend elementary
school. Today, because of research and care supported by the CF Foundation
with money raised through donations from families, corporations and
foundations -- the median predicted age of survival for people with CF is
now more than 36 years.


The Cystic Fibrosis Foundation, headquartered in Bethesda, MD, is a
donor-supported, nonprofit organization committed to finding therapies and
ultimately a cure for CF, and to improving the lives of those with the
disease. For more information on CF and the programs of the CF Foundation,
call (800) FIGHT CF or visit cff.


Vertex Safe Harbor Statement


This press release may contain forward-looking statements, including
statements that Vertex expects (i) that the Phase I clinical study for
VX-770 is expected to enroll more than 50 individuals; (ii) that the study
will evaluate the safety, tolerability and pharmacokinetics of escalating
single and multiple doses of VX-770 in healthy volunteers and single doses
of VX-770 in patients with CF; (iii) that compounds such as VX-770 have the
potential to change the course of CF; (iv) that it will evaluate VX-770 in
the coming months to determine the next steps for the VX-770 development
program; (v) to begin dosing VX-770 in patients with CF later this year;
and (vi) VX-770 may act to restore the function of the cystic fibrosis
transmembrane conductance regulator (CFTR) protein. While management makes
its best efforts to be accurate in making forward-looking statements, such
statements are subject to risks and uncertainties that could cause Vertex's
actual results to vary materially. These risks and uncertainties include,
among other things, the possibility that CFFT could terminate its financial
support under its agreements with Vertex early, risks that efforts to
develop VX-770 may not proceed due to financial, technical, scientific,
commercial or other reasons, that clinical trials may not proceed as
planned due to technical, scientific, supply or patient enrollment issues,
that actual clinical studies of VX-770 will not reflect the results
obtained in pre-clinical and nonclinical testing, and other risks listed
under Risk Factors in Vertex's Form 10-K filed with the Securities and
Exchange Commission on March 16, 2006.


Lexiva is a registered trademark of the GlaxoSmithKline group of
companies.


Vertex's press releases are available at vrtx.


Vertex Pharmaceuticals Incorporated

vrtx



View drug information on Lexiva.

GlaxoSmithKline Discontinues Clinical Development Of Investigational Protease Inhibitor Brecanavir

GlaxoSmithKline plc (GSK) today confirms that, due to insurmountable issues regarding formulation, development of brecanavir, an investigational protease inhibitor for the treatment of HIV, has been discontinued. Brecanavir was in phase II clinical development.


Clinical trial investigators have been notified and directed to transition their patients to marketed antiretrovirals, or appropriate treatments available through expanded access programmes.


???GSK is dedicated to excellence in the care of individuals with HIV infection, and we will continue our efforts to find effective treatments with improved resistance profiles for these patients,??? said Lynn Marks, MD, Senior Vice President, GSK Medicine Development Centre for Infectious Diseases. ???Despite this disappointing outcome with brecanavir, we remain unwavering in our commitment to find new solutions to meet the challenges of HIV/AIDS.???


GlaxoSmithKline one of the world??™s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer.


Cautionary statement regarding forward-looking statements


Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2005.


GlaxoSmithKline

gsk/

New HARMONIC FOCUS™ Provides Advantages In Surgical Efficiency, Performance And Patient Outcomes

Ethicon Endo-Surgery announced at the American College of Surgeons 93rd Annual Clinical Conference the launch of the HARMONIC FOCUS™ Curved Shears, a new nine centimeter advanced energy device specifically designed for fine and delicate dissections in open surgeries. The HARMONIC FOCUS™ Curved Shears, part of the HARMONIC advanced energy family of ultrasonic surgical devices from Ethicon Endo-Surgery, is designed to help improve patient outcomes.


Data show use of HARMONIC devices is associated with reduced intraoperative blood loss, and less analgesic consumption1 in thyroidectomy (vs. electrosurgery); reduced blood loss in superficial parotidectomy when compared with cold knife parotidectomy; and reduced serous drainage and drain days in axillary dissection vs. electrosurgery.


The HARMONIC FOCUS™ Curved Shears enhances surgical efficiency by allowing surgeons to precisely dissect, grasp, coagulate and cut without exchanging instruments. The innovative device also seals five-millimeter vessels, as well as lymphatics, and offers advantages in terms of efficiency, innovation and performance, and safer dissection near vital structures than electrosurgery.


"A significant benefit of the HARMONIC FOCUS™ Curved Shears is the minimal thermal spread, which is important to help reduce the risk of nerve injury for patients," said Peter Angelos, MD, PHD, University of Chicago.


The HARMONIC FOCUS™ Curved Shears can be used for procedures where precise dissection and efficiency are vital, including thyroidectomies, parotidectomies and axillary dissections, offering surgeons improved comfort with a smaller, lighter hand piece that enhances balance.


"The HARMONIC FOCUS™ Curved Shears is an important new option in the HARMONIC line of products," said Professor Paolo Miccoli, Chief of Surgery, University of Pisa. "This innovation will help cut down on instrument transfers making surgery more efficient than traditional cut, clamp and tie methods."


HARMONIC devices use ultrasonic energy to simultaneously cut and coagulate soft tissue and vessels at much lower temperatures than RF-based devices, resulting in minimal thermal damage to the surrounding tissue. Since there is no electrical current on the active blade of HARMONIC, there is no electrical energy being transferred to or through the patient.


HARMONIC technology has been used in more than 6.5 million procedures worldwide, including a variety of open and laparoscopic procedures in the areas of general surgery, gynecologic, colorectal, otolaryngologic, orthopedic and plastic surgery.


"The introduction of the HARMONIC FOCUS™ Curved Shears represents our dedication to working with the surgical community to transform patient care through innovation," said Kevin Lobo, president, Ethicon Endo-Surgery, U.S. "Ethicon Endo-Surgery further demonstrated this commitment in 2007 through the introduction of 12 new products worldwide in various areas of surgical focus."















2007 Product Launch Highlights at ACS


The ECHELON™ 45 ENDOPATH® STAPLER, featuring system-wide compression, provides a true 45 mm staple line and a 21 mm wide jaw aperture, while allowing for easy tissue positioning and manipulation. The Echelon™ 45 ENDOPATH® Stapler is designed to be a new standard in endoscopic stapling for use in bariatric, thoracic, general and gynecologic surgery.


The new ENDOPATH® DEXTRUS™ MINIMALLY INVASIVE ACCESS SYSTEM is comprised of the DEXTRUS™ Hand Access Port, Retractors and the DEXTRUS™ Finger-mounted Instruments. Together, they form the first complete hand-assisted laparoscopic system designed to maximize laparoscopic surgery. The Access Port along with the five finger-mounted instruments can be used for a broad base of procedures within colorectal, gynecologic, urologic and general surgery.


The ENDOPATH® XCEL™ BLADELESS 15 mm TROCAR is designed for bariatric surgeons to enhance gastric banding procedural performance by minimizing the risk of gastric band damage and providing smooth, one handed instrument exchange through the lowest drag force and greatest abdominal wall retention of any 15 mm trocar currently on the market. The ENDOPATH® XCEL™ BLADELESS 15 mm TROCAR features with a bladeless tip features a durable universal seal and stability threads designed to stay in place for hassle-free device insertion and retention.


The MAMMOTOME® EX Probe with enhanced technology is designed to decrease force to penetrate, allowing for rapid and precise positioning. Tests demonstrate the sharper EX tip reduces penetration force into the breast tissue by 63 percent.


The NEOPROBE neo2000® BLUETOOTH® Probe is the first Bluetooth® gamma-guided cordless probe from Ethicon Endo-Surgery in partnership with Neoprobe Corporation. The gamma-guided surgery device features a single user-controlled button and is used intraoperatively to better detect and quantify radioactive emissions from body tissues or organs.


The PROXIMATE® LINEAR CUTTER 75 mm GOLD CARTRIDGE is sized between the blue and green cartridges with a closed staple height of 1.8 mm and offers surgeons more stapling options for open surgery. The PROXIMATE® LINEAR CUTTER has intermediate locking positions allowing for accurate repositioning of tissue.


About Ethicon Endo-Surgery


Ethicon Endo-Surgery, Inc., develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information on the company can be found at ethiconendo. ECHELON™, ENDOPATH® XCEL™, HARMONIC, HARMONIC FOCUS™, MAMMOTOME®, AND PROXIMATE® are trademarks of Ethicon Endo-Surgery. NEOPROBE and neo2000® are trademarks of Neoprobe Corporation. The Bluetooth® word mark and logos are owned by Bluetooth SIG, Inc., and any use by Neoprobe or its representatives is under license.


References


1 Evaluation of the ultrasonic dissector in thyroid surgery: a prospective randomized study. Defechereux T, Rinken F, Maweja S, et al. Acta Chir Belg (2003); 103:274-277.


2 Use of the HARMONIC SCALPEL® in Superficial and Total Parotidectomy for Benign and Malignant Disease. Jackson LL, Gourin CG, Thomas DS, et al. Laryngoscope, 115:1070-1073, 2005.


3 Usefulness of Ultrasound Scissors in Reducing Serous Drainage After Axillary Dissection for Breast Cancer: A Prospective Randomized Clinical Study. Lumachi F, Burelli P, Basso SMM, et al. The American Surgeon Jan 2004 Vol 70, 80-84.

Ten Percent Screened In European Phase III Study Of Diamyd® Diabetes Vaccine

Ten percent of the children participating in the European phase III study have been screened and about a dozen have received their first injection.


"The studies are progressing as planned and we expect to keep on schedule," says Erika Hillborg, Director of clinical trials at Diamyd Medical. "The Swedish part of the study began right before summer and we are just starting in Holland, England, Germany, France, Finland, Slovenia, Italy, and Spain. We have already injected the first patients in the parallel phase III study in the US."


Strategically, the most important date for the study is when the last patient receives his/her first injection (last patient in) since this determines the results date. If all goes as planned, the study's 15-month results will come in during the latter part of 2010, after which the market registration application for the Diamyd® vaccine can be completed.


"Diamyd Medical could have the world's first diabetes vaccine out on the market in 2011," says Elisabeth Lindner, President and CEO. "We are going through big changes and are preparing the company to become a pharmaceutical company. There is enormous potential for the future."


Diamyd Medical is a Swedish biopharmaceutical company focusing on development of pharmaceuticals for treatment of autoimmune diabetes and its complications. The company's most advanced project is the GAD-based drug Diamyd® for type 1 diabetes and for which Phase III trials are ongoing in both the US and Europe. Furthermore, the company has initiated clinical studies within chronic pain, using its Nerve Targeting Drug Delivery System (NTDDS). The company has also out-licensed the use of GAD for the treatment of Parkinson's disease.


Diamyd Medical has offices in Sweden and in the US. The share is quoted on the OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). Further information is available on the company's web site: diamyd


This information is disclosed in accordance with the Securities Markets Act, the Financial Instruments Trading Act or demands made in the exchange rules.

Diamyd Medical

Preliminary Data From Experimental Study Demonstrate Increased Mortality In Stroke Patients Treated With Epoetin Alfa

Ortho Biotech has become
aware of preliminary data from an investigator-initiated experimental study
of the effects of Epoetin alfa in patients with acute ischemic stroke. In
this study, patients suffering acute ischemic stroke who were treated with
Epoetin alfa within six hours of the onset of stroke symptoms died more
frequently than patients receiving placebo. Ortho Biotech has reported this
information to the U.S. Food and Drug Administration and to European
regulatory authorities. Additional analyses are underway to better
understand these preliminary results.



Epoetin alfa is marketed as EPREX(R) / ERYPO(R) outside the U.S. by
Janssen-Cilag, as PROCRIT(R) in the U.S. by Ortho Biotech and as EPOGEN(R)
in the U.S. by Amgen. None of these products are approved in any country
for use in patients with acute ischemic stroke. Epoetin alfa is a member of
the class of erythropoiesis-stimulating agents (ESAs). ESAs should be used
strictly in accordance with their approved indications and dosing
recommendations.



This investigator-initiated experimental study was designed and
conducted by an investigator in Europe. Ortho Biotech provided study drug
and funding, but the company had no role in designing or conducting the
study. The investigator has informed the company that the results of this
study will be submitted for publication promptly.


Ortho Biotech

orthobiotech

Early-Life Exposure To BPA May Affect Testis Function In Adulthood

Exposure to environmental levels of the industrial chemical bisphenol A, or BPA, in the womb and early life may cause long-lasting harm to testicular function, according to a new study conducted in animals. The results are being presented Monday at The Endocrine Society's 92nd Annual Meeting in San Diego.


"We are seeing changes in the testis function of rats after exposure to BPA levels that are lower than what the Food and Drug Administration and Environmental Protection Agency consider safe exposure levels for humans," said Benson Akingbemi, PhD, the study's lead author and an associate professor at Auburn (Ala.) University. "This is concerning because large segments of the population, including pregnant and nursing mothers, are exposed to this chemical."


Many hard plastic bottles and canned food liners contain BPA, as do some dental sealants. BPA acts in a similar manner as the female sex hormone estrogen and has been linked to female infertility. This chemical is present in placenta and is able to pass from a mother into her breast milk. In their study of the male, Akingbemi and colleagues saw harmful effects of BPA at the cellular level, specifically in Leydig cells. These cells in the testis secrete testosterone, the main sex hormone that supports male fertility. After birth, Leydig cells gradually acquire the capacity for testosterone secretion, Akingbemi explained.


The process of testosterone secretion was decreased in male offspring of female rats that received BPA during pregnancy and while nursing. The mothers were fed BPA in olive oil at a dose of either 2.5 or 25 micrograms of BPA per kilogram of body weight. Akingbemi said this is below the daily upper limit of safe exposure for humans, which federal guidelines currently put at 50 micrograms per kilogram of body weight. A control group of pregnant rats received olive oil without BPA. Male offspring, after weaning at 21 days of age, received no further exposure to BPA.


Using a combination of analytical methods, the investigators studied the development of Leydig cells in male offspring. The capacity for testosterone secretion was assessed at 21, 35 and 90 days of age. The amount of testosterone secreted per Leydig cell was found to be much lower in male offspring after early-life exposure to BPA than in offspring from control unexposed animals.


"Although BPA exposure stopped at 21 days of age, BPA's effects on Leydig cells, which were seen immediately at the end of exposure and at 35 days, remained apparent until 90 days of age, when the rats reached adulthood," Akingbemi said. "Therefore, the early life period is a sensitive window of exposure to BPA and exposure at this time may affect testis function into adulthood."


Funding from this study came in part from the Graduate Research Scholars Program of Alabama EPSCoR (Experimental Program to Stimulate Competitive Research), Tuscaloosa, Ala., and the National Institute of Environmental Health Sciences.

HIV Vaccine Study First To Show Some Effectiveness In Preventing HIV

A Phase III clinical trial involving more than 16,000 adult volunteers in Thailand has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection. According to final results released by the trial sponsor, the U.S. Army Surgeon General, the prime boost combination of ALVAC(R)( )HIV and AIDSVAX(R) B/E( )lowered the rate of HIV infection by 31.2% compared with placebo.


"This is the first HIV vaccine candidate to successfully reduce the risk of HIV infection in humans. We are very excited and pleased with the outcome of this trial and congratulate all those who participated in it," said Lieutenant General Eric Schoomaker, Surgeon General, U.S. Army. "In addition, this study is an outstanding example of international and interagency collaboration involving many partners from the Thai and U.S. governments, private companies, non-profit organizations and volunteers."


In the final analysis, 74 placebo recipients became infected with HIV compared to 51 in the vaccine regimen arm. The efficacy result is statistically significant. The vaccine regimen had no effect on the amount of virus in the blood of volunteers who became HIV-infected during the study. More detailed results of this study will be presented next month at the AIDS Vaccine Conference, October 19 through 22 in Paris, France.


This finding has important implications for the design of future HIV vaccines and how they are tested, however additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection. Given the significant threat of HIV infection worldwide, an efficacious vaccine is urgently needed, as part of a broader prevention effort to help control the epidemic.


Collaborating partners on this study, referred to as RV144, include the U.S. Army, the Thai Ministry of Public Health, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, sanofi pasteur, and Global Solutions for Infectious Diseases (GSID). The collaborators are already working with external experts to determine the need for additional studies on this vaccine regimen and consider the impact of this study's findings on other HIV vaccine candidates.


"These results show that development of a safe and effective preventive HIV vaccine is possible, " said Colonel Nelson Michael, Director, Division of Retrovirology, Walter Reed Army Institute of Research and Director, U.S. Military HIV Research Program (MHRP). "While these results are very encouraging, we recognize that further study is required to build upon these findings."


Colonel Jerome Kim, Deputy Director, Science, MHRP and the HIV vaccines product manager for the U.S. Army added that, "knowledge gained through this study will be used to accelerate future study design and testing as researchers continue the search for a safe, globally-effective HIV vaccine."


The U.S. Army would like to thank the more than 16,000 Thai men and women who consented to participate in this trial and the efforts of the Thai Ministry of Public Health and all collaborators for their hard work in achieving this important milestone.


RV144 Phase III Trial Background


RV144 tested a prime-boost vaccine strategy that combined two vaccines based on strains (subtypes) of HIV that circulate in Thailand. The first, or "prime" vaccine, known as ALVAC HIV, was developed by sanofi pasteur and the booster vaccine, AIDSVAX B/E, was originally developed by VaxGen and is now licensed to Global Solutions for Infectious Diseases.


The proof-of-concept study, which began in 2003, was designed to evaluate the vaccine strategy's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood of those who became infected after they enrolled in the study.


More than 16,000 HIV-negative men and women between the ages of 18 to 30 participated in the study; half of these participants received the prime-boost vaccine regimen and half received placebo. Volunteers received vaccinations over the course of six-months and were followed for an additional three-years. Before agreeing to participate, all volunteers were informed of the potential risks associated with receiving the experimental vaccine regimen used in this study and consented to participate in the study. Volunteers continued to receive an HIV test every six-months for three-years following vaccination, in addition to counseling on how to prevent becoming infected with HIV.

Depression: Neuralstem Files FDA Application For First Drug Therapy

Neuralstem, Inc. (NYSE Amex: CUR) announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin two Phase I safety trials to test NSI-189, its first small molecule compound, for the treatment of major depression. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in depression.



"This marks more than just a significant milestone for the company: we believe our compound represents the next generation of antidepressant treatment based on a new mechanism of action that may, for the first time, fundamentally modify the disease," said Neuralstem President & CEO Richard Garr. "NSI-189 also validates Neuralstem's proprietary neural stem cell screening approach as a source for discovering novel compounds that affect complex stem cell biology rather than a single molecular target."



"The antidepressants that are available today are based on the theory of serotonin deficiency," explained Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "NSI-189 is based on a new theory that chronic exposure to stress hormones can inhibit the growth of new neurons in certain regions of the brain. This can lead to hippocampal atrophy and depression. We believe that this neurogenic approach to brain self-repair may be applicable in multiple diseases including: Alzheimer's disease, mild cognitive impairment, dementia, schizophrenia, cognitive complications from diabetes, post-traumatic stress syndrome and traumatic brain injury, all of which are indications that the company intends to pursue with this new class of drugs."



About NS-189: Stimulating Neurogenesis To Address Central Nervous System Conditions



NS-189 is the first in a class of compounds that Neuralstem plans to develop into orally administered drugs. These appear to have the effect of "recruiting" the patient's own neural stem cells to repair or protect against damage to the Central Nervous System (CNS) from disease or injury.



NSI-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in- vitro. In mice, NSI-189 both stimulated neurogenesis of the hippocampus and increased its overall volume as well. Therefore, NSI-189 may reverse the human hippocampal atrophy seen in major depression and schizophrenia. This program has received significant support from both the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).



The Neuralstem small molecule platform results from discoveries made through Neuralstem's ability to generate stable human neural stem cell lines suitable for screening large chemical libraries. The platform complements Neuralstem's cell therapy platform, in which brain and spinal cord stem cells are transplanted directly into diseased areas to repair and/or replace diseased or dead cells.



About the Trial



Neuralstem has filed an IND with the FDA to conduct two Phase I safety trials. The first trial will involve normal healthy volunteers testing the safety of escalating doses of a single administration of NSI-189. The second trial is designed to test the safety of escalating doses of daily administration for 28 days in depressed patients. The entire trial is expected to be approximately one year in duration.



Further information will be available on the Neuralstem website after the FDA approves the trial.