For Those on Watch, Hope Springs Eternal as Hair Trials Inch Along

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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Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.