Skin and Hair Replacement
Intercytex (www.intercytex. com) is a cell therapy company using ordinary cells rather than stem cells, focusing on wound care and skin and hair replacement. Lead product ICX-PRO is a dressing containing human dermal fibroblasts in a human fibrin-based gel matrixa combination that can "kick start" the healing process, according to CEO Nick Higgins.
Phase II gave promising results in venous leg ulcers, with 85% of participants showing a reduction in wound size and 41% with smaller ulcers showing complete wound closure. ICX-PRO has now gone on to Phase III.
ICX-SKN is a skin replacement in preclinical development that consists of human dermal fibroblasts in a collagen matrix, overlaid by human keratinocytes and is intended for grafting onto chronic and acute wounds and burns. "We are further ahead in this than anyone else," Higgins says. "We can make skin that looks and feels like skin and can be sutured."
Finally, the hair replacement product, ICX-TRC is "the first example of organ generation," according to Higgins, and will address the huge and under-served market for treatment of hair loss in men and women. The therapy involves taking a biopsy from the patient's scalp and culturing the dermal papilla cells which, when transplanted, produce new hair. In Phase I, five out of seven patients showed new hair growth.
Integragen (www.integragen.com) is involved in genetic tests for complex diseases in the area of metabolism and neuropsychiatry. The company has a predisposition test, carried out in accredited labs, for autism based on four genes that can be used in the very young so that therapy can be started earlier.
"The genes involved in the test play a major role in brain development and will lead to better understanding and treatment of autism," said David Brady, vp, business development. The company is also interested in other neuropsychiatric conditions such as schizophrenia, bipolar disorder, and Alzheimer's disease, and is working with the National Institute for Mental Health tissue collection.
Integragen is also working on a test for MODY, a form of type 2 diabetes where early and accurate diagnosis is important, as the disease needs to be treated differently from other types of diabetes. In what would be a natural development of this work, the company intends adding diagnostics for other types of diabetes to its portfolio.
"The findings will advance our understanding of diabetes generallymaybe helping to find genes that predispose toward complications, such as retinopathy," said Brady.
Santhera (Liestal, Switzerland) was formed in 2004 as a merger between Graffinity and MyoContract and is focused on developing small molecule drugs, rather than gene therapies, for neuromuscular disease, working with only validated targets. The lead program involves a known drug, idebenone (SNT-MC17), which is about to enter Phase II in a collaboration with the NIH involving 48 patients who have Friedreich's ataxia, a rare and life-threatening disorder. A Phase III trial in Europe is planned for later this year.
The company also just announced a Phase IIa trial of SNT-MC17 in Duchenne muscular dystrophy. The drug is an antioxidant that supports mitochondrial function. It protects the muscle cells of the heart from oxidative stress, which otherwise leads to complications in these neuromuscular disorders and often proves fatal.
"What makes us unique is our use of a relevant animal model of neuromuscular diseases," said CSO Thomas Meier, Ph.D. The company has a preclinical pipeline that it will develop in neuromuscular disease and out-license in other therapeutic areas. It has licensed its program on novel DPP (dipeptidyl peptidase) IV inhibitors for metabolic disease to Biovitrum (www.biovitrum.com).
Oxford Biomedica (www. oxfordbiomedica.co.uk) is advancing its lead product, Trovax. "All patients in Phase II showed an immune response to the therapy, there were no safety issues, and 90 percent had disease control. The level of clinical benefit is superior to chemotherapy alone. What is specially significant is that the higher the immune response, the higher the clinical benefit," explained Nick Woolf, senior vp, corporate strategy. Phase III is due to start in 2006. The company recently outlined its plan for the trial in renal cell carcinoma with the FDA and is in discussion with a number of potential licensing partners. Trovax is potentially applicable to all kinds of solid tumors.
MetXia, the company's pro-drug therapy, is in Phase II in pancreatic cancer and has shown encouraging results. Meanwhile, positive preclinical data was recently presented on Oxford Biomedica's antibody conjugate therapy, targeted to the tumor antigen 5T4, which is found in most cancers. This program has been licensed out to Wyeth.
The rest of the pipeline includes a neurology program involving lentiviral delivery. "We will have three products in clinical trials in the next 12 months," said Woolf. Revenue is being generated by alliances such as that signed recently with Sigma Aldrich (www.sigmaaldrich.com) for the commercialization of Oxford Biomedica's LentiVector, a lentivirus-based gene delivery technology.