Intercytex, the UK’s first dedicated regenerative medicine company, is stepping increasingly closer to bringing pioneering new treatments for baldness and chronic wounds to market, an achievement which would earn it a place in medical history books.

The Manchester-based company, which commenced operations in 2000, is a world leader in regenerative medicine which concerns repairing or replacing damaged tissue or organs, and is led by scientists with exceptional credentials in the field. Founder and chief executive Dr Paul Kemp previously worked in the United States for Organogenesis Inc where he was one of the principal scientists engaged in research which led to the US Food and Drug Administration’s approval of the first manufactured organ for sale.

Having worked on first generation cell-based therapies, Kemp and his 48 strong team are now developing innovative second generation cell therapies aimed at billion dollar global markets. The company, in which Scottish Equity Partners invested £2 million in 2003, has two lead products. TrichoCyte is a revolutionary hair transplant technology involving the injection of cultured follicular cells into the scalp to induce hair growth.

Millions of bald people spend up to $20,000 on hair treatments each year, adding up to a hefty annual spend of $1.5 billion on hair loss therapies. “There are 54 million people with substantial hair loss in America alone,” says Kemp, who is confident that Intercytex can make a lucrative entry into the market.

He says TrichoCyte involves less pain and discomfort than conventional transplants and there is evidence it is also more effective. “We’re just finishing a Phase I trial in Manchester involving 10-15 patients and the data is very encouraging,” he says.

The plan is initially to market the product through hair transplant surgeons but Kemp predicts that eventually it will move down the skill chain like Botox, with more people licensed to carry out the procedure.

Trials are at a more advanced stage with the company’s other lead product ProtoDerm, which stimulates repair in chronic wounds such as venous stasis ulcers and diabetic foot ulcers. ProtoDerm is close to concluding a multi-site Phase II clinical trial involving 90 patients in both the UK and Poland. “The initial results are very exciting. The risk of ProtoDerm failing now is relatively small,” Kemp says.

The wound treatment market is fragmented but Kemp estimates it is worth around $500 million annually in the U.S. ProtoDerm has the potential to save money for healthcare providers and also to ease suffering for patients, especially those with severe diabetic foot ulcers which can lead to lower limb amputation. Intercytex maintains that early detection and treatment of these ulcers may reduce amputations by up to 85%.

Intercytex is also developing a novel treatment for end-stage renal disease which offers an alternative to dialysis or donor transplants. Kemp hopes to licence the technology which involves the transplant of kidney precursors which have the capacity to grow into a fully functional kidney. The company’s research pipeline also includes two more skincare products, EpiDerm and ProtoSkin which are expected to enter clinical trials in 2006.

Pushing back the boundaries of science requires exceptional talent and skills, but Kemp knows that launching a commercial product takes a lot more. He gained invaluable insight into the process during nine years as a top research scientist in the United States.

“I learned how much more there needs to be done above and beyond the science and how to break it up into bite-size chunks and achieve it bit by bit,” he says.

Kemp also acknowledges the support provided by SEP in helping the company to achieve its objectives:

“SEP has been really helpful in mentoring us and in giving us a really good insight to the outside world at any given time,” he says. “They have benchmarked us against competing companies of the same size. We find these things very helpful, they definitely provide an added strength for us.”