Healthpoint Biotherapeutics Initiates Phase III Study of Unique Investigational Cell-Based Therapy for Venous Leg Ulcers
Published: Sep 11, 2012
FORT WORTH, Texas, Sept. 11, 2012 /PRNewswire/ -- Healthpoint Biotherapeutics today announced the initiation of a Phase III clinical trial investigating the efficacy of HP802-247 for the treatment of venous leg ulcers. HP802-247 is an investigational allogeneic living cell bioformulation containing keratinocytes and fibroblasts. The study is designed to evaluate complete wound closure in subjects receiving HP802-247 plus compression therapy compared to those receiving vehicle control plus compression therapy over the 12-week treatment period.
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.
"Following the favorable results achieved in our Phase IIb trial, we are very pleased to be initiating the Phase III study for this first-in-class cell-based therapy," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint Biotherapeutics. "In addition to this multicenter North American study, our development strategy includes a second multicenter trial, which we plan to initiate next year at centers across Europe."
The North American study is a randomized, double-blind study involving subjects 18 years of age and older with venous leg ulcers of at least 6 weeks but not more than 24 months duration. The ulcers must be between 2 cm2 and 12 cm2 in area at presentation. Approximately 440 subjects will be enrolled across 45 investigational centers in the United States and Canada.
"As is evidenced by our ongoing $60 million investment in a state-of-the-art cell sciences research and manufacturing facility at our headquarters in Fort Worth, Healthpoint Biotherapeutics is committed to advancing the development of our lead pipeline candidate," said Travis E. Baugh, President and Chief Operating Officer of Healthpoint Biotherapeutics. "We look forward to the results of the pivotal registration studies for HP802-247 and, ultimately, to bringing a significant advance in the treatment of venous leg ulcers to the millions of patients suffering from this debilitating condition."
For more information about the HP802-247 North American clinical trial, go to www.LegSoreStudy.com, or call 866-910-2020 to speak with a clinical trial recruitment specialist.
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.
Positive results for a Phase IIb clinical trial investigating the efficacy of HP802-247 in venous leg ulcers were recently published in The Lancet. The study was a randomized, double blind, dose-finding study involving 228 subjects enrolled across 35 investigational centers in the United States and Canada. 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.
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