Stem Cell Therapeutics to conduct two phase 2 trials of Ntx-265 for stroke

By E. Janene Geiss

Philadelphia, Jan. 20 - Stem Cell Therapeutics Corp. said Friday that it will soon begin two phase 2 human clinical trials to evaluate the company's lead therapy, Ntx-265, as a treatment for stroke.

These plans were made possible by several recent achievements, including the completion of an initial public offering that raised $8.5 million, according to a company news release.

Other recent milestones that make these phase 2 studies possible include positive preclinical results, identifying the lead therapeutic regimen, Ntx-265, completing dosing of a phase 1 study and discussing development with potential partners, officials said.

"Each year there are approximately 15 million people worldwide that suffer a stroke, many of whom require an effective treatment to promote functional recovery following that stroke. Stem Cell continues to focus its efforts toward developing drugs that will address this major unmet medical need," Joseph Tucker, president and chief executive officer, said in the release.

The company said its therapeutic approach has shown efficacy in animal models of central nervous system disorders, including stroke.

Stem Cell said it is taking advantage of these findings with a strategy to rapidly proceed with clinical development in diseases where there are significant market opportunities and unmet medical needs.

Some upcoming milestones for the company include animal studies validating proposed clinical regimen with Ntx-265, release of phase 1 clinical trial results, initiating Ntx-265 phase 1a single site, open-label safety study in the first quarter, initiating Ntx-265 phase 2b multi-site, proof-of-concept study with anticipated completion in the second quarter of 2008 and starting development of a second program.

Stroke, which is the third leading cause of death in the United States and second worldwide, has an incidence of 700,000 victims in the United States each year. The American Heart Association estimated the U.S. economic costs at $56.8 billion for 2005.

Because of the lack of effective therapies currently available, it is estimated that about 4% of stroke patients are treated with interventional drugs, officials said.

Stem Cell Therapeutics is a Calgary, Alta., biotechnology company focused on the development of its technology platform and intellectual property to selectively induce a patient's own stem cells to proliferate in the brain.

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