BioWorld International Correspondent
LONDON - CellFactors plc said it made a breakthrough with its bone-regeneration product, Skeletex, demonstrating its ability to induce spontaneous formation of new bone in muscle, the orthopedic industry's key test of the effectiveness of bone-forming agents.
CEO Iain Cubitt told BioWorld International, "For the orthopedic industry, the critical proof for a bone-forming compound is ectopic bone formation in muscle. This is far more difficult to achieve than bone next to bone."
Several leading companies are evaluating Skeletex for uses such as spinal fusion and prosthetics, and Cubitt said he wrote to them all with news of the development. "In the animal model bone formed two weeks after putting Skeletex in the site, and there is bone forming around this bone. This meets the industry standard and elevates what we are doing from interesting to must-have."
The animal model indicates that Skeletex will form ectopic bone at lower doses than the current leading product, bone morphogenic protein. Skeletex, a mixture of cell factors extracted from a human chondrocyte cell line, also is much cheaper to produce.
CellFactors, based in Cambridge, also has taken the precaution of going back and remaking Skeletex from Australian sources to ensure it is free of new-variant Creutzfeldt-Jakob's disease. "The U.S. won't accept any cells of European origin because of CJD," Cubitt said.
Cubitt is in the process of trying to raise £8 million (US$12.3 million) in a private round. "It is taking time because at the moment venture capitalists only want to make follow-on investments in companies they already support," he said. CellFactors has raised £4.2 million since it was founded in 1997.