By Mary Welch

Organogenesis Inc. filed a premarket approval application (PMA) supplement for its Apligraf skin construct in the treatment of diabetic foot ulcers.

"Apligraf was approved by the FDA in May 1998 for venous leg ulcers, and now we're applying for diabetic foot ulcers," said Carol Hausner, senior director of investor and public relations for the Canton, Mass., company. "We feel this is an exciting indication for Apligraf because there are lots of patients who could use Apligraf - some 600,000 to 800,000 Americans a year. But, in addition, it is a serious medical condition that frequently leads to amputation. It is a serious disease with serious consequences and hopefully this will help drive patient use."

About one in five ulcers lead to amputation, Hausner said.

The PMA supplement was filed based on a prospective, randomized pivotal trial involving 208 patients treated with either Apligraf plus standard care or diabetic ulcer standard care alone. The use of Apligraf healed 56 percent of the ulcers within 12 weeks compared to 38 percent healing with standard care alone (p=0.01). Use of Apligraf was also found to reduce time to healing, with complete healing achieved in a median of 65 days, compared to 90 days with standard care alone (p=0.01).

Apligraf is the first living product to show efficacy in diabetic foot ulcers in a prospective, randomized pivotal trial, Hausner said.

Apligraf is an all-natural product engineered from discarded foreskins of human infants. It is a living human skin equivalent containing both epidermis and dermis layers of skin. Rather than using a scaffold for the cells to grow around, Apligraf is made by culturing the cells in a 3-dimensional culture system that yields the two layers of skin.

Unlike human skin, Apligraf does not contain blood vessels, hair follicles or sweat glands.

In January 1996, Novartis Pharma AG, of Basel, Switzerland, licensed worldwide marketing rights for Apligraf in all indications for $37.5 million in equity investments, milestone payments and research support, plus manufacturing payments and royalties.

Organogenesis' stock (AMEX:ORG) closed Wednesday at $10, up 75 cents.