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

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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.