HEALTHPOINT-Sponsored Venous Leg Ulcer Clinical Trial Enrolls First Subject For Second Phase II Study
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HEALTHPOINT, Ltd. announced that it has enrolled the first of a planned 235 subjects into a Phase II dose response study investigating an experimental, cell-based wound therapy ---HP802-247---intended for the treatment of venous leg ulcers. HP802-247 is a topical spray containing living keratinocytes and fibroblasts. The first patient was enrolled at The Center for Clinical Research near San Francisco, Calif., led by the site's principal investigator, Alexander Reyzelman, DPM. The study is being conducted by 28 investigators in 18 states.
"The start of enrollment into this multi-center, randomized trial is an important milestone for HEALTHPOINT," said Bert Slade, M.D., FAAAAI, Chief Medical Officer at HEALTHPOINT and co-author of the trial protocol. "This is the largest cell therapy dose ranging trial ever undertaken in the area of wound healing."
The trial is the second of two planned-dose response trials, extending the dose range being tested and exploring two plausible dose frequencies. Enrollment into the trial is preceded by screening and run-in phases and is expected to continue through the middle of 2010. The first trial showed promising results over a four-fold range of cell concentrations administered weekly.
This trial is evaluating the benefits and safety of enhancing wound healing by using metabolically active donor cells to support the patient's own skin cells' healing ability. HP802-247 utilizes allogeneic cells, which are living human cells derived from an individual donor that are subsequently grown in a tissue culture, and then applied to an unrelated patient. The HP802-247 product consists of both keratinocytes and fibroblasts, the two major cell types found in human skin. Using a unique delivery system, the cells are sprayed onto the wound surface in a self-polymerizing protein mesh intended to help the cells to adhere to the tissue.
Previous research strongly suggests that wound healing is accelerated by the application of living cells, particularly when both keratinocytes and fibroblasts are present together. By allowing the cells to be in contact with each other following spraying onto the wound surface, it is thought that growth promoting and healing signals will be generated that can support healing of the wound by the patient's own cells.
Typically caused by impaired microcirculation secondary to venous hypertension, venous leg ulcers are increasingly common, are costly, and are often a cause of prolonged suffering for patients. Characterized as difficult to heal, many such ulcers develop into chronic, nonresponsive wounds despite application of standard treatments.
"Making an innovative, effective treatment available is a strategy that can help such high risk wounds and provide tremendous benefits to both patients and society," said Dr. Slade. "Based on an estimated 2.5 million venous leg ulcers in the United States alone and actual direct treatment costs reported to be over $9,000 per patient, the current annual cost of treating these wounds is likely in the many billions of dollars."
"We are excited to be working with HEALTHPOINT on this important study," said Dr. Reyzelman. "We're aided greatly by HEALTHPOINT's investment in cutting edge technology to support this trial, including new laser-equipped digital cameras that can measure wound size at each clinic visit."
"We believe development of our HP802-247 product will result in helping millions of patients worldwide who suffer from these ulcers," said Travis E. Baugh, President of HEALTHPOINT. "The novel format of this cell-based therapy shows great potential to deliver a compelling, cost-effective option."
The current trial is part of HEALTHPOINT's ongoing development strategy for advancing wound care therapies and further enhances HEALTHPOINT's evidence-based dossier for regulatory filings in both the United States and Europe, according to Mr. Baugh.
About the Study
The study is a randomized, double-blind, dose-finding study involving subjects 18 years of age and older who have had venous leg ulcers for a minimum of six weeks and a maximum of 24 months. The ulcers must be between 2 cm2 and 12 cm2 in area at presentation. The study will assess both the time to complete wound closure and the proportion of complete wound closures in each cohort. It is designed to determine the effectiveness of two cell concentrations and two dosing frequencies of HP802-247 when combined with standard care, compared to placebo plus standard care, in healing venous leg ulcers over a 12-week treatment period. All trial patients undergo compression bandaging with a four-layer system (Profore(R) System) in order to control leg swelling caused by the underlying vein dysfunction.
HP802-247 consists of two components that are sprayed sequentially on the wound bed at the time of treatment: a fibrinogen solution and a cell preparation containing a mixture of growth arrested, living, allogeneic epidermal keratinocytes and dermal fibroblasts. Based on in vitro studies, HP802-247 is expected to release various growth and angiogenic factors into the microenvironment of the wound through administration of these living, metabolically active, but nonproliferating cells that are trapped on the wound surface in a thin fibrin matrix. The secreted growth and angiogenic factors are anticipated to stimulate the patient's own cells to heal the wound.
About HEALTHPOINT, Ltd.
Since 1992, HEALTHPOINT has been dedicated to innovative technologies for the prevention and treatment of acute, chronic and burn-related wounds. The company is presently focused on the research and development of novel biologics and pharmaceuticals intended to improve clinical and quality of life outcomes. Currently marketed products include: Collagenase SANTYL(R) Ointment, OASIS(R) Wound Matrix, HYDROFERA BLUE(R) Bacteriostatic Wound Dressings, and SURGICEPT(R) Waterless Surgical Hand Antiseptic. HEALTHPOINT is also committed to advancing the care and treatment of wounds through support of industry leading continuing education from THE WOUND INSTITUTE(R). To learn more about this comprehensive and award winning educational resource, please visit TheWoundInstitute.com(R). HEALTHPOINT is a DFB Pharmaceuticals, Inc. affiliate company, and is based in Fort Worth, Texas.
OASIS is a registered trademark of Cook Biotech, Inc.; HYDROFERA BLUE is a registered trademark of Hydrofera, LLC; and PROFORE is a registered trademark of Smith & Nephew.
HEALTHPOINT, SANTYL, SURGICEPT, THE WOUND INSTITUTE, and TheWoundInstitute.com are registered trademarks of HEALTHPOINT, Ltd.
Source: HEALTHPOINT, Ltd
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