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Apligraf Data in Diabetic Foot Ulcers Presented; Data Shows Apligraf Heals Significantly More Patients, Faster
CANTON, Mass.--(BW HealthWire)--April 26, 1999--Organogenesis Inc. (AMEX:ORG) announced the first results from the Apligraf(R) diabetic ulcer pivotal trial are being presented today at The Symposium on Advanced Wound Care meeting in Anaheim, California. The data show that use of Apligraf heals significantly more diabetic foot ulcers than high quality standard care alone. Use of Apligraf was also found to significantly reduce average time to healing compared with standard care alone. Apligraf is currently FDA-approved for use in venous leg ulcers. The Company plans to submit a PMA supplement for use in diabetic foot ulcers within the next twelve months.
An estimated 600,000 people in the US alone suffer from diabetic foot ulcers. These ulcers can frequently lead to amputation: 50,000 - 60,000 amputations are performed on US diabetics each year. In addition to the quality of life implications, these ulcers are costly to the medical system. Despite the medical need, achievement of better treatments for diabetic foot ulcers has been a major challenge in wound care. The goal is for more effective treatments that can heal more patients, faster, to reduce the risk of infection and the need for amputation.
The Apligraf pivotal trial in diabetic foot ulcers is a prospective, randomized, controlled study being conducted in twenty-four centers across the US with over 200 treated patients. Patients randomized to active control received high quality standard care; patients randomized to Apligraf received the product and standard care. Efficacy was assessed at 12 weeks; patients were followed for 6 months. The data being presented today are from the two largest centers in the study. It includes all patients treated at one of the centers and a comparable number of the first patients treated at the other center for a total of 46 patients.
These data show that Apligraf healed significantly more diabetic foot ulcers than standard care alone: 83% (19/23) of Apligraf-treated patients healed compared with 48% (11/23) receiving standard care alone (p<0.05). Use of Apligraf also significantly reduced the average time to healing, from a median of 91 days with standard care to 35 days with Apligraf (p<0.01). All baseline ulcer characteristics were comparable between the two treatment groups, as was the reporting of adverse events.
Michael L. Sabolinski, MD, Senior Vice President, Medical and Regulatory Affairs, said, "Our trial was designed to provide excellent standard care, setting a high hurdle for Apligraf. We are very encouraged by these preliminary results. Additional data from this study, including the full study results, are planned for presentation this year."
Apligraf is the only mass-produced product containing living human cells approved and marketed in the US today. Like human skin, Apligraf is living, void of synthetics and bi-layered, having both a differentiated epidermal layer and a lower dermal layer. Apligraf contains living human skin cells (fibroblasts and keratinocytes) and the structural protein, collagen. Unlike skin, Apligraf does not contain structures such as blood vessels, hair follicles and sweat glands.
Organogenesis Inc. designs, develops and manufactures medical products containing living cells and/or natural connective tissue. The Company's product development focus includes living tissue replacements, cell-based organ assist devices and other tissue-engineered products. Lead product Apligraf is marketed in the US and Canada; Novartis Pharma AG has global Apligraf marketing rights. The research pipeline also includes VITRIX(TM) living soft tissue replacement, a bioartificial liver and a vascular graft.
Statements in this press release which are not historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. There can be no assurance that an Apligraf PMA supplement for use in diabetic ulcers will be submitted within twelve months or that such a supplement will be approved by the FDA in a timely manner, if at all.
CONTACT:
Organogenesis Inc.
Carol Hausner, 781/575-0775
