Robert Kirsner, MD, PhD, To Present Results For Phase 2b 6-Month Follow-Up Trial Of Unique Investigational Cell-Based Therapy For Venous Leg Ulcers
FORT WORTH, Texas, July 25, 2012 /PRNewswire/ -- Healthpoint Biotherapeutics today announced that the results of a 24-week open-label follow-up to the HP802-247 Phase 2b trial will be presented by Robert Kirsner, MD, PhD, on Friday, July 27, 2012, from 3:55-4:15 pm, during the American College of Wound Healing and Tissue Repair held at the Swissotel in Chicago. HP802-247 is an allogeneic living cell bioformulation containing keratinocytes and fibroblasts currently being investigated for the treatment of venous leg ulcers.
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 24-week open-label extension of this Phase 2b trial was designed to evaluate the status of the target wound (e.g., open, re-opened or healed), as well as the status of the periwound area following the 12-week treatment period. HP802-247 was not administered to patients during this 6-month follow-up period, though subjects in the vehicle group crossing over to the open-label extension were allowed to receive other active interventions. Consistent with the results observed during the 12-week double-blind treatment period, the best dose group continued to perform best throughout the open-label follow-up study. At the end of the open-label follow-up study, 83% of wounds were healed in this cell-treated group vs. 58% in the vehicle group. Overall, most of the wounds healed at the end of the double-blind study remained healed at the end of the follow-up study, regardless of treatment group.
"Benefits in the active treatment groups were found to persist through six months of follow-up after dosing had stopped," noted Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint Biotherapeutics. "The durability of healing is just as important as getting the wound healed in the first place."
"The benefit of cell therapy persisted, both in terms of healed wounds remaining closed and the proportion of healed wounds exceeding what was seen in the control group," added Dr. Kirsner, who served as one of the lead investigators for the trial and is a tenured Professor and Vice Chairman in the Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine. "Despite receiving a variety of available treatments during this six month follow-up, the vehicle group never achieved a comparable proportion of wounds closed."
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. 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.
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.
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Posted: July 2012