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an early stage clinical trial (conducted in the Philippines) of its Hair Stimulating Complex (HSC). The patients received eight injections of HSC (double the number of injections in the 2010 pilot study), with a repeat dose at week six. The treatment was well-tolerated and no study-related adverse effects were reported. At 12 weeks, the patients showed a 46.5 percent increase in total hair count above and beyond the “statistically significant” improvement in hair growth and density that was reported at 12 weeks in the 2010 pilot study.
An additional physician-sponsored investigational new drug (IND) study is being conducted in the United States by Dr. Craig Ziering with 10 subjects, both men and women. Histogen says the study was initiated to evaluate the safety and efficacy of HSC, and also produced “hair growth effects in patients with diffuse hair loss.”
The company’s disclosure triggered a flurry of hopeful comments on Xconomy, beginning with a post by “Hope for Baldness,” who linked to Histogen’s PDF file and wrote, “I always read comments here and never post but I was force to post this. Very exciting!!!!! The cure is near for real. No bullshit!!!!!!! I have proof!!!!!!”
You could say they got their dander up. But Histogen’s findings barely scratch the surface. These are only partial results from an early stage, phase I/II trial. Even if the company continues to show positive results, it will be years before Histogen could bring its HSC treatment to market.
In response to my query about Histogen’s timeline for development, the company passed along an email from CEO Naughton:
“We anticipate pivotal trials in the U.S. or Asia will begin next year. As it is Histogen’s business model to bring each of its product applications to market through partnerships with leaders in different industries and geographic locations, strategy for future clinical trials of HSC will be largely dependent upon the regions of interest for such partners. We hope to have an NDA [new drug application] filed in the U.S. or Asia before the end of 2015.”
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