By Karen Pihl-Carey

Organogenesis Inc. said its skin-graft product, Apligraf, heals more diabetic foot ulcers and at a faster rate than standard care, according to results from its recently completed pivotal trial.

"We are very excited by these results," said Carol Hausner, director of investor and public relations for the Canton, Mass.-based company. "The company does plan to submit a PMA [premarket approval application] supplement to the FDA within the next six months. The diabetic foot ulcer is a large market and an important medical need."

Study results were presented Wednesday at a medical symposium held with the European Tissue Repair Society and the Wound Healing Society's multinational meeting in Bordeaux, France. They provided data for a trial started in 1996 and including 208 patients treated at 24 medical centers in the United States. Patients with comparable baseline ulcer characteristics received either Apligraf or standard care and results were assessed at 12 weeks. The patients were then followed for six months.

Results showed 56 percent of patients treated with Apligraf healed by the end of the 12 weeks, while 36 percent of patients receiving standard care healed by that time (p=.0082). Another finding: It took Apligraf-treated ulcers an average of 65 days to heal, compared with the 90 days it took ulcers receiving standard care (p=.0026).

About 600,000 to 800,000 diabetics in the United States develop a foot ulcer in their lifetime. About one in five ulcers lead to amputation, the company said. And diabetics are more frequently hospitalized for foot complications than for anything else.

"One of the things that is very interesting about this market is over 50,000 amputations will be done each year, underscoring the need for new therapies in this area," Hausner told BioWorld Today.

Preliminary data released in April from 46 patients in the pivotal trial showed Apligraf healed 83 percent of patients treated, compared with the 48 percent healed under standard care, and the median time to heal with Apligraf was 35 days, compared with 91 days to heal with standard care. (See BioWorld Today, April 26, 1999, p. 1.)

The investment community was not swayed by Wednesday's news, however. Organogenesis' stock (AMEX:ORG) closed at $9.125 Wednesday, up 6.25 cents per share.

Apligraf is the first living product to show efficacy in diabetic foot ulcers in a prospective, randomized, controlled pivotal trial, and it is the only product containing living human cells to have gained FDA PMA marketing approval, the company said. It was approved in May 1998 for use in the treatment of venous leg ulcers. It has the potential to be used in burns, chronic wounds and skin disruptive diseases, such as epidermolysis bullosa. Organogenesis also is conducting a pivotal trial using Apligraf for the cosmetic outcome of skin surgery.

Similar to human skin, Apligraf contains an upper epidermal and a lower dermal layer, as well as the living human skin cells, epidermal keratinocytes and dermal fibroblasts. It does not contain Langerhans cells, melanocytes, macrophages, lymphocytes, or blood vessels, hair follicles and sweat glands.