BioWorld International Correspondent

LONDON - Intercytex Ltd. raised £12 million (US$21.3 million) in its third funding round, enabling it to start a multicenter Phase III U.S. trial of the lead product ICX-PRO, a cell therapy for treating chronic wounds.

At the same time the Cambridge, UK-based company released results of the Phase IIb trial of ICX-PRO in which all the patients who were treated with the higher dose of the product (that will be used in the Phase III study) achieved complete closure of chronic venous leg ulcers.

Nick Higgins, CEO, told BioWorld International: "This was an internal round with six of our eight VCs investing. £12 million was the amount we were looking for, and gives us enough money to get ICX-PRO through Phase III and file a biologics license application in the first quarter of 2007."

ICX-PRO consists of active, allogenic human dermal fibroblasts in a fibrin-based gel. The cells, which are not modified in any way, are isolated, cultured and manufactured in Intercytex's approved GMP facility in Manchester. The product is delivered as a disk of gel five centimeters in diameter, and with a shelf life of 21 days.

The Phase IIb trial treated patients who had suffered from a venous leg ulcer for at least six months and failed to respond to standard therapy. Alongside 44 percent on the higher dose who had complete wound closure, 31 percent of patients who received ICX-PRO at a lower dose showed a measurable reduction in wound size.

The FDA has approved a blinded, randomized multicenter Phase III trial in which about 200 patients with non-responsive leg ulcers will be treated. Half will receive the active product, a quarter will get placebo of fibrin with no active cells and a quarter will receive standard therapy. The end point will be 100 percent wound closure at 12 weeks.

Higgins said Intercytex is starting to make approaches to potential partners. "Once you get to Phase III people start to take you seriously. We will probably do a mix of building our own sales force for specialist, end-of-the-road wound care centers in the U.S. and partnering for other parts of the market."

The funding round will allow the company to move its second cell therapy product for treating male pattern baldness into Phase II trials. This is an autologous treatment in which dermal cells are extracted from a small biopsy, cultured and expanded over three weeks and then microinjected into the scalp, using a specialized delivery system.

In the Phase I trial in seven volunteers there were no safety issues and five had hair regrowth. Intercytex now is planning a Phase II trial in the U.S. and UK.

"The existing system of follicular hair transplants only gives one-for-one. We've put in an amplification step which gives us 4,000 [dermal papilla] cells for every one we take out," Higgins said.

Intercytex refers to this product as an "aesthetic medicine." However, there are several hurdles to be overcome to develop an acceptable cosmetic procedure, as it costs around £20,000 currently, is painful and requires several visits to complete the treatment.

A third skin-replacement product is expected to reach the clinic next year. This is an allogenic product that is intended to provide an off-the-shelf replacement for skin grafts. It consists of human dermal fibroblasts in a collagen matrix overlaid with keratinocytes, and is strong enough to be sutured into place.

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