FORT WORTH, TX, JANUARY 21, 2010 – Healthpoint today announced its acquisition of two cellbased technologies from Intercytex Limited along with the corresponding intellectual property (including patents), validated fibroblast and keratinocyte cell banks, and related production and testing equipment. Terms of the deal were not disclosed by Healthpoint.
The therapeutic candidates acquired include CYZACT™--human dermal fibroblasts delivered via a fibrin sheet and produced utilizing a streamlined manufacturing process as compared to similar products—and ICX-SKN--a combination of fibroblasts and fibrin matrix that are remodeled to produce a collagen matrix that allows the engineered tissue to remain intact in a hostile wound environment. The validated cell banks and equipment will be transferred to Healthpoint’s cell-based manufacturing facility in Lausanne, Switzerland, which is authorized by Swissmedic (the Swiss Regulatory Agency) for the production of both allogeneic (i.e., derived outside of patient’s own body) cell therapies and autologous (i.e., derived from patient’s own body) tissue products.
“Healthpoint is pleased to add these complimentary assets to our ongoing wound healing and cell sciences development programs,” said Travis E. Baugh, President and Chief Operating Officer of Healthpoint. “Incorporating these unique three dimensional cell therapy constructs into our portfolio extends the range of potential therapeutic targets for our regenerative medicine pipeline.”
The acquired technologies will join two other cell-based therapies in the Healthpoint portfolio:
KERAGRAF™ -- one of the first human stem cell-derived products developed for wound care (an autologous epidermal equivalent)—and the novel biologic treatment, HP802-247 (a cell therapy spray suspension), which entered into Phase IIb evaluation in the United States last year.
CYZACT™ is a topical wound care product comprised of active, allogeneic human dermal fibroblasts embedded in a human fibrin gel matrix. The product is designed to stimulate active repair and closure in persistent chronic wounds.
ICX-SKN is an early stage technology that has been designed to replace autologous skin grafts in severe burn patients, eliminating the need for tissue excision, skin grafting and creation of donor site wounds, which can lead to additional scars and risk of infection. ICX-SKN provides an architecture that is sufficiently durable to integrate and persist in burns, and provide immediate and long-term closure that is robust enough to withstand the proteases (enzymes that break down proteins and peptides) present during wound repair. These unique differentiating characteristics of ICX-SKN also make it ideal for treatment of other skin deficits that require a surgical graft.
“We intend to evaluate a full range of options as part of the overall integration of these assets into our ongoing development operations,” commented Duncan Aust, PhD, Senior Vice President, Research and Development at Healthpoint. “Our opportunity assessment will include a variety of delivery formats optimized for specific indications—for example, gel, spray and/or three-dimensional scaffold delivery systems—as well as appropriate clinical trial designs for each condition we ultimately choose to pursue.”
About KERAGRAF™
KERAGRAF™ is a differentiated, autologous epidermal equivalent, cultured from outer root sheath progenitor cells located in the hair follicles. The resulting product, which has the appearance of small “dermal wafers”, stimulates proliferation of keratinocyte leading edges that are critical to successful wound closure.
Commercial opportunity assessment for the possible introduction of KERAGRAF™ to the US and European markets is currently underway.
About HP802-247
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 and Phase IIa studies, HP802-247 is expected to release various growth and angiogenic factors into the micro-environment of the wound through administration of these living, metabolically active, but non-proliferating cells that are trapped on the wound surface in a thin fibrin matrix. The secreted growth and angiogenic factors are believed to stimulate the patient’s own cells to heal the wound.
In March 2009, Healthpoint initiated a Phase IIb clinical trial investigating the efficacy of HP802-247 in venous leg ulcers. The randomized, double blind, dose-finding study will involve approximately 235 recruited subjects at more than 25 investigational centers in the United States.
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® Ointment, OASIS® Wound Matrix, HYDROFERA BLUE® Bacteriostatic Wound Dressings, SURGICEPT® Waterless Surgical Hand Antiseptic and ULTRACEPTTM Antiseptic Handwash. HEALTHPOINT 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 is a DFB Pharmaceuticals, Inc. affiliate company, and is based in Fort Worth, Texas. For more information, visit the HEALTHPOINT website at www.healthpoint.com.
OASIS is a registered trademark of Cook Biotech, Inc.: HYDROFERA BLUE is a registered trademark of Hydrofera, LLC.
SANTYL, SURGICEPT, THE WOUND INSTITUTE and THEWOUNDINSTITUTE.COM are registered trademarks of Healthpoint, Ltd.
ULTRACEPT, CYZACT and KERAGRAF are trademarks of Healthpoint, Ltd.
