BioWorld International Correspondent

XCellentis NV, a subsidiary of Innogenetics NV, reported positive progress from its ongoing Phase II trial of LyphoDerm as a treatment for hard-to-heal venous leg ulcers, based on a preliminary analysis of a subgroup of participants.

Recruitment into the randomized, open-label, parallel-group study was completed in May. A total of 195 patients based at 24 centers in four countries are participating. Keith Harding, head of the department of surgery at the University of Cardiff in the UK, is leading the study, which has three treatment arms: standard care, which consists of a hydrocolloid dressing under compression; LyphoDerm, a lysate of freeze-dried human keratinocytes administered in a topical formulation; and the topical formulation alone. The primary endpoint is defined as the incidence of wound closure within 24 weeks.

An interim analysis of the first 60 subjects indicated a positive trend. Patients in both the LyphoDerm and the topical formulation arms exhibited a complete wound closure rate at least 20 percent better than those in the standard-care group. Company CEO Patrice Froidure declined to elaborate further.

"The reason we cannot say anything more is because it's only on 60 patients and we have more than 120 to go," he told BioWorld International. "All we know is the two [treatment] arms are doing better than the standard care." The Ghent, Belgium-based company plans to report the full results in January.

If the company classified LyphoDerm as a medicinal product, further clinical data would be required. However, if it classified the drug as a medical device, additional data would not be needed.

"If we go to Phase III, we'll do both the U.S. and Europe," Froidure said.

LyphoDerm is XCellentis' second-generation wound-care product. Its predecessor, Ceal, which consists of cultured keratinocytes grown into epithelial sheets, is on the market in several European countries.

"We don't intend to push it that much because of regulatory hurdles," Froidure said. Different countries have different designations for the product, he said, while others do not have any appropriate regulations in place. LyphoDerm, he said, is more user friendly and can be stored and reconstituted easily. It addresses a market worth about €1 billion, the company said. Standard care currently fails in about 40 percent of patients.

The product is thought to work by releasing growth factors that stimulate the wound-healing process. "That platform can be applied to indications other than wound care," Froidure said. It has potential application in soft-tissue regeneration, he added.

The company has a third product in development, UlcoDress Plus, a wound dressing that consists of a biocompatible and biodegradable hydrogel polymer matrix with bacteriostatic properties. Discussions with regulatory authorities with a view to a European launch next year are underway, Froidure said.

XCellentis was spun out of Innogenetics, also of Ghent, in February 2001 to develop the latter firm's wound-care business. It is still wholly owned by its parent, but will "probably" seek additional shareholders next year, Froidure said.

"It's on the cards that Innogenetics would be a minority shareholder down the road," he said.