BioWorld International Correspondent

LONDON - Tissue therapy specialist Intercytex Group plc is raising £12 million (US$23.9 million) in a placing, enabling it to commercialize its first product, an anti-wrinkle treatment, and complete a U.S. Phase III trial of ICX-Pro in treating venous leg ulcers.

"We are very pleased with the outcome," Richard Moulson, the company's chief financial officer, told BioWorld International. "We had a good case and got a good hearing, but I wouldn't say there is a wall of money out there waiting for small biotechs."

The Manchester, UK-based company is placing 21.1 million shares at £0.52 each, a 13.3 percent discount. Intercytex joined London's Alternative Investment Market in July 2006, raising $26.5 million. Moulson said existing investors are following on.

Intercytex is currently in discussions over alterations to its Phase III trial of ICX-Pro. Following a review of the first 108 patients to join the proposed 216-patient trial, the data safety and monitoring board told the company its forecasts for the control arm were too low.

"They told us to continue with the trial, so we infer it is working," Moulson said. "But assumptions about the control arm were too low; the bandaging-only arm was healing more patients than expected."

It is thought that a further 150 patients will need to be added, pushing the completion of enrollment out to the end of 2007, with data expected late summer 2008.

"If we were GlaxoSmithKline, we'd just get out the small change. For a company of our size, it is a significant increase in cost and timing," Moulson said. "However, in effect, we've been told it works, so you have to look at the extra nine months from that perspective."

Once completed, the Phase III trial is designed to provide sufficient data to support a biologics license application filing. Initially, the product will be directed at the 20 percent to 30 percent of ulcers that do not heal after three to six months, but Intercytex believes that the ease of use of the product and the speed of healing it induces will support health economics arguments that move it into the dressing market over time.

The new money also allows Intercytex to launch its first product, Vavelta, a fibroblast treatment for wrinkles. Although it is classified as a drug in the U.S. and some countries in Europe, in the UK, it is not regulated as a medicine. A Phase II trial is ongoing, but the product will be launched in the UK on the basis of the Phase I safety trial.

Vavelta is administered by injection, and Intercytex will target specialist aesthetic surgeons as the route to market. It is intended to institute a certification process and training in the injection technique. The model here is Isolagen, an anti-aging treatment prepared from the recipient's own fibroblast cells.

Further back in the pipeline, in January Intercytex began a Phase II trial of ICX-Trc for treating male pattern baldness. Unlike wrinkles, the UK regulators consider baldness to be a disease, and along with other finer distinctions related to the mode of action, ICX-Trc will be classified as a medicine.

"This is going to be a high-value product, and its application will be restricted to specialists," Moulson said.

No Comments