By Mary Welch

Organogenesis Inc. said preliminary data from a pivotal trial show Apligraf, its skin-graft product, healed diabetic foot ulcers in less time than the standard quality care.

Carol Hausner, director of investor and public relations for the Canton, Mass.-based company, said the results represent 46 patients at the two largest centers of 24 in the study.

¿An important thing to remember is that the endpoints were hard, [such as] wound closure, as opposed to soft endpoints like wound improvement,¿¿ Hausner told BioWorld Today.

The preliminary results of the pivotal trial are expected to be presented at the Symposium on Advanced Wound Care, in Anaheim, Calif., today.

Begun in 1996, the study has completed its enrollment of 200 patients, randomized for some to receive high-quality standard care, while others receive the same standard care as well as Apligraf. Results were assessed at 12 weeks, with patient follow-up continuing for six months. All baseline ulcer characteristics were comparable between the two treatment groups at the start of the study, as was the reporting of adverse effects.

The study will be completed next month, with a pre-market approval application supplement filing expected within the next 12 months.

Preliminary results showed Apligraf healed significantly more diabetic foot ulcers than standard care alone. Of those treated with Apligraf, 83 percent experienced complete wound closure, versus 48 percent with standard care.

The second endpoint was average time to heal. Again, Apligraf provided statistically significant results, with the median time to heal being 35 days using Apligraf, versus 91 days with standard care.

¿That is an important endpoint because the longer the wound is open, the greater the risk of infection, which unfortunately may lead to amputation,¿ Hausner said. ¿The goal is to get healed as quickly as possible to reduce the risk of infection and amputation. Of course, the faster the healing, the fewer medical resources you use.¿

Some 600,000 people in the U.S. alone suffer from diabetic foot ulcers, with 50,000 to 60,000 amputations performed on U.S. diabetics yearly.

Apligraf is a manufactured skin replacement composed of living human dermal and epidermal skin cells and collagen. During manufacture, the cells self-organize and differentiate to establish their natural three-dimensional arrangement, the company said. Unlike human skin, Apligraf does not contain structures such as blood vessels, hair follicles and sweat glands.

Apligraf was approved by the FDA last May for venous leg ulcers, and was launched the following month. Novartis AG, of Basel, Switzerland, is Organogenesis¿ marketing partner. (See BioWorld Today, May 27, 1998, p. 1.)

For the first quarter of 1999, some 1,600 units of Apligraf were used, up significantly from the 500 units used during the third quarter of 1998, the first quarter it became available. About 500 medical centers are currently using the product. Cost is about $975 per unit.

In addition to the already-approved venous leg ulcer indications and the trials for diabetic foot ulcers, Organogenesis completed a study in burns, from which some data were published in February. The company has also completed two studies in skin surgery, and some data from that research also have been published. More are expected to be disclosed later this year.

Under way is a large pivotal trial using Apligraf for the cosmetic outcome of skin surgery. Trials with Apligraf for pressure sores will be started this year.

Organogenesis¿ stock (AMEX:ORG) closed Friday at $12, up $0.062. n