LONDON ¿ The cell therapy company CellFactors plc announced the U.S. Patent Office gave it notice of allowance on its bone regeneration product, Skeletex, and said it now has data to show the product stimulates bone growth in vivo.

The company plans to start a clinical trial in periodontal disease in 2002 and to fund it currently is raising #3 million (US$4.3 million) in a private round.

Skeletex is not a cell line, but cartilage matrix containing a mixture of the growth factors and other proteins that initiate the process of bone formation in humans. It is produced in a human chondrocyte cell line.

CEO Iain Cubitt told BioWorld International, ¿The way our intellectual property portfolio is going, we think we really will be a leader in the cell therapy industry. We think this patent means that if you want to grow human cells that form bone, you need a license from CellFactors.¿

Earlier this year CellFactors, based in Cambridge, made a similar claim when it was granted a U.S. patent on its method of immortalizing human neural cells. That patent covers the immortalization of neural stem cell lines using any gene or other immortalizing agent, and the use of any mechanism to control the proliferation of the cells after administration.

Cubitt said that in time the cell therapy industry will coalesce around a handful of companies with strong IP portfolios, as has happened with monoclonal antibodies. ¿It¿s important to be in there with lots of chips, and we are building a good position,¿ he said.

He added that the animal data on Skeletex are encouraging. ¿This is the first time we have seen the formation of vascularized bone stimulated by a product added to a damaged bone area.¿

Preparations are being made for a clinical trial that is expected to start in the first half of 2002. Because bone formation is a fast process, Cubitt expects to have data showing proof of principle three months after the trial begins.

There is interest from potential partners in licensing the technology, Cubitt said, adding that that rather than granting one overall license, he will ¿slice and dice¿ the market into different application areas. The cost of the licenses will take into account that ¿there is no other way of stimulating bone growth.¿

CellFactors is focusing on Parkinson¿s disease as the first target in neural cell therapy. Cubitt said this is going more slowly than Skeletex, but the #3 million funding will allow the company to ramp up its neural work.

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