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.
четверг, 23 июня 2011 г.
среда, 22 июня 2011 г.
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.
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.
вторник, 21 июня 2011 г.
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
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
понедельник, 20 июня 2011 г.
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."
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."
воскресенье, 19 июня 2011 г.
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.
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.
суббота, 18 июня 2011 г.
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
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
пятница, 17 июня 2011 г.
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.
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.
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