Results For Phase 2b Trial Of Unique Investigational Cell-Based Therapy In Venous Leg Ulcers Published In The Lancet

FORT WORTH, Texas, Aug. 2, 2012 /PRNewswire/ -- Healthpoint Biotherapeutics today announced that the results for its Phase 2b clinical trial investigating the efficacy of HP802-247 in venous leg ulcers is published on The Lancet, beginning August 3, 2012, with Online First access to the article, followed by print publication in the next issue. HP802-247 is an investigational allogeneic living cell bioformulation containing keratinocytes and fibroblasts currently under development for the treatment of venous leg ulcers.

"We are very pleased that the trial results are appearing in such a prestigious general medical journal, thus recognizing the impact chronic wounds have across multiple medical specialties," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint Biotherapeutics.

Venous leg ulcers affect approximately 2.5 million Americans and are associated with impaired circulation most commonly resulting from damaged veins and/or valves. They typically appear as an open lesion, or ulcer, on the lower extremities, are very slow to heal and often reoccur due to the chronic nature of the underlying disease process.

The Phase 2b trial was designed to determine the potential effectiveness of two cell concentrations and two dosing frequencies of HP802-247, when combined with standard care, compared to control plus standard care, in healing venous leg ulcers over a 12-week treatment period. The study was a randomized, double blind, dose-finding study involving 228 subjects enrolled across 35 investigational centers in the United States. Overall, HP802-247 achieved statistical significance, as compared with control plus standard care, in both the primary and secondary endpoints. HP802-247 was generally well tolerated in the study with the most frequently reported adverse events being skin ulcers, cellulitis, wound infection, and skin irritation.  The safety profile of the active groups was similar to the vehicle control.   

The citation for the Phase 2b study manuscript is: Kirsner RS, Marston WA, Snyder RJ, Lee TD, Cargill DI, Slade HB. A Multicentre Randomized Dosing Trial of Spray-Applied Cell Therapy With Human Allogeneic Fibroblasts and Keratinocytes for the Treatment of Chronic Venous Leg Ulcers. Lancet 2012;pending. The manuscript can be accessed online at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60644-8/abstract. 

The publication is accompanied by an expert Comment in which the authors note, "In a well-done clinical trial in The Lancet, Robert Kirsner and colleagues have clearly shown that a specific cell therapy for venous leg ulcers can lead to a significantly higher healing rate than for vehicle alone in hard-to-heal [venous] wounds for which compression treatment has been applied unsuccessfully."

About HP802-247

HP802-247 is an investigational allogeneic living human cell bioformulation that 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 believed to release various growth factors and cytokines into the micro-environment of the wound. These living cells are anticipated to interact with the patient's own cells to stimulate wound healing.  HP802-247 has been designed to deliver a defined cell ratio (keratinocyte:fibroblasts) to support optimal tissue regeneration.

About Venous Leg Ulcers

Venous leg ulcers are increasingly common and costly, and a cause of prolonged suffering for patients. These wounds are caused by swelling and inflammation secondary to blockage or backflow in the veins of the legs. Many venous ulcers fail to heal even after 3 months of standard treatment and develop into chronic, non-healing wounds. Based on an estimated figure of 2.5 million venous leg ulcers in the United States alone and a study of actual direct treatment costs of $9,685 per person, the annual cost of treating these wounds is likely in the many billions of dollars. Accordingly, the availability of innovative and more effective treatment strategies for such high-risk wounds could provide tremendous benefits to both patients and society.

About Healthpoint Biotherapeutics

Healthpoint Biotherapeutics is a biopharmaceutical company focused on the development and commercialization of novel, cost-effective solutions for dermal repair and regeneration. The company's research and development strategy is centered around next-generation bioactive therapies for the treatment of chronic wounds. Currently marketed products include Collagenase SANTYL^® Ointment, OASIS^® Wound Matrix, OASIS^® Ultra Tri-Layer Matrix and REGRANEX^® (becaplermin) Gel 0.01%. Healthpoint Biotherapeutics is also committed to advancing the care and treatment of wounds through support of industry leading continuing education from The Wound Institute^®. To learn more about this comprehensive and award winning educational resource, please visit TheWoundInstitute.com^®.  Healthpoint Biotherapeutics is a DFB Pharmaceuticals, Inc., affiliate company, and is based in Fort Worth, Texas. For more information, visit the company website at www.Healthpointbio.com.

HEALTHPOINT and related logo, SANTYL, THE WOUND INSTITUTE, THEWOUNDINSTITUTE.COM and REGRANEX are registered trademarks of Healthpoint, Ltd.

OASIS is a registered trademark of Cook Biotech, Inc.

SOURCE Healthpoint Biotherapeutics