Organogenesis Announces Success in Apligraf Diabetic Foot Ulcer Pivotal Trial; Statistical Significance Shown in Healing More Patients and in Healing Patients Faster.CANTON, Mass.--(BUSINESS WIRE)--Aug. 25, 1999--
Full Study Results Being Presented Today At
International Medical Meeting
Organogenesis Inc. (AMEX AMEX
See: American Stock Exchange :ORG) today announced that the results from the completed Apligraf(R) pivotal trial in diabetic foot ulcers show use of Apligraf heals significantly more ulcers and heals them significantly faster than standard care alone. Apligraf is the first living product - and the only skin construct - to show efficacy in diabetic foot ulcers in a prospective, randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. , controlled pivotal trial. The study results are being presented today at a medical symposium being held in conjunction with the joint European Tissue Repair Society/ Wound Healing Society multinational meeting in Bordeaux, France.
STUDY DESIGN AND FINDINGS
The Apligraf diabetic ulcer pivotal trial was conducted at twenty-four medical centers across the US. A total of 208 patients were treated with either Apligraf plus standard care or diabetic foot ulcer standard care alone. Patient baseline characteristics were comparable between treatment groups. Efficacy was assessed at twelve weeks; patients were followed for six months.
The study results are:
--56% of Apligraf-treated ulcers healed by twelve weeks, compared with 38% of ulcers receiving standard care alone (p=0.0082).
--Average time to healing was 65 days for Apligraf-treated ulcers, compared with 90 days for ulcers receiving standard care alone (p=0.0026).
Michael L. Sabolinski, MD, Senior Vice President, Medical and Regulatory Affairs, Organogenesis Inc. said, "Diabetic foot ulcers represent an important medical need as they commonly occur, are increasing in incidence and often lead to amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly . Apligraf is the only manufactured skin construct shown to heal significantly more ulcers, faster, in a large, randomized, prospective, controlled study. We plan to submit a PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.
PMA Progressive muscular atrophy supplement for use in diabetic foot ulcers within the next six months."
David R. Epstein, Chief Operating Officer Chief Operating Officer (COO)
The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. , Novartis Pharmaceuticals Corporation, said, "We are very pleased with the results of this pivotal trial evaluating the use of Apligraf for diabetic foot ulcers. In recent years Novartis has steadily increased its efforts to develop and market more effective treatments for diabetes and its destructive complications. Now Apligraf promises to be an important option for the millions of patients around the world who suffer from diabetic foot ulcers."
DIABETIC FOOT ULCERS - A LARGE AND GROWING MEDICAL PROBLEM
About 16 million people in the US, or six percent of the population, have diabetes. Approximately one in every seven diabetics will ultimately suffer from at least one diabetic foot ulcer. Currently, 600,000 to 800,000 people in the US have diabetic foot ulcers.
Foot complications are the most frequent cause of hospitalization among outpatient diabetics, and diabetic foot ulcers often lead to amputation. Each year, 50,000 - 70,000 amputations are performed on diabetics in the US. A panel of diabetic medical experts recently estimated that about one in every five diabetic foot ulcers ultimately leads to amputation. In addition to the high personal toll, diabetic foot ulcers are conservatively estimated to cost the healthcare system over $1 billion per year.
"Despite the important medical advances that have been made in the treatment of diabetic foot ulcers in the past fifty years, there remains a significant need for more effective therapies," said Aristidis Veves MD, DSc, Research Director at the Foot Center at the Beth Israel Deaconess Medical Center Both an international and regional referral center, Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts is a major teaching hospital of Harvard Medical School. It was formed out of the 1996 merger of Beth Israel Hospital (founded in 1916) and (formerly The Joslin Clinic). "We were pleased to participate in this trial and were impressed with the results seen at our center, which we have presented and published."
Like human skin, Apligraf is living, all-natural and bi-layered, with both an upper epidermal and a lower dermal layer. It contains living human skin cells - epidermal keratinocytes Keratinocytes
Cells found in the epidermis. The keratinocytes at the outer surface of the epidermis are dead and form a tough protective layer. The cells underneath divide to replenish the supply. and dermal fibroblasts Fibroblasts
A type of cell found in connective tissue; produces collagen.
Mentioned in: Skin Grafting . The keratinocytes are differentiated to form the strata of the human epidermis, including the outer stratum corneum. Unlike human skin, Apligraf does not contain Langerhans cells, melanocytes Melanocytes
Skin cells derived from the neural crest that produce the protein pigment melanin.
Mentioned in: Malignant Melanoma, Skin Pigmentation Disorders
melanocytes , macrophages Macrophages
White blood cells whose job is to destroy invading microorganisms. Listeria monocytogenes avoids being killed and can multiply within the macrophage. or lymphocytes, or structures such as blood vessels, hair follicles Hair follicles
Tiny organs in the skin, each one of which grows a single hair.
Mentioned in: Alopecia and sweat glands.
Apligraf is the only manufactured product containing living human cells to have gained FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. PMA marketing approval: in May 1998, Apligraf was approved for use in the treatment of venous leg ulcers, another type of chronic wound. Additional potential uses for Apligraf include use in skin surgery, burns, skin disruptive diseases such as epidermolysis bullosa Epidermolysis Bullosa Definition
Epidermolysis bullosa (EB) is a group of rare inherited skin diseases that are characterized by the development of blisters following minimal pressure to the skin. and other types of chronic wounds such as pressure sores.
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. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 six months, that such a supplement will be approved by the FDA in a timely manner, if at all, or that Apligraf will be the first living product commercialized for diabetic foot ulcers. Apligraf(R) is a registered trademark of Novartis.