For Those on Watch, Hope Springs Eternal as Hair Trials Inch Along
Waiting for the biotech industry to advance new treatments for male pattern baldness (as well as female hair loss) might seem about as exciting as watching hair grow. But some people have a lot of skin in the game, if you know what I mean.
More than just a few people, actually. San Diego’s Histogen estimates that hair loss affects some 40 million men and 21 million women in the United States alone. Histogen, which has been developing a bio-engineered treatment for stimulating hair growth, says less than 7 percent seek treatment for their hair loss “due to the limitations of available options.”
For these people, any incremental improvement in hair growth can be thrilling—even life-changing—which helps explain a burst of enthusiasm we’ve noticed in recent days in messages penned below a 2011 article about Boston-based Follica on the Xconomy Boston website. With close to 1,500 comments posted over the past 14 months our readers have shown no loss for words, making this one article a defacto online message board and a virtual support group for the follically challenged.
As I reported in 2010, few life sciences companies have gotten as much mileage from a pilot trial that enrolled two dozen patients as Histogen has for its much-anticipated treatment. The company says its formulation consists of proteins, including growth factor molecules, secreted by human fibroblast cells grown in a laboratory culture. The concoction is injected just below the scalp.
Over the past week, gentle and not so-gentle visitors to the Follica comment page have seized on the early results of Histogen’s latest experimental trial, which Histogen CEO Gail Naughton presented a week ago in Raleigh, NC, during the annual meeting of the Society for Investigative Dermatology. Naughton gave an oral summary of the data on May 11 and presented a poster the following day on “Stimulation of hair growth in humans by cell-secreted proteins.”
The data has not yet been published in a peer-reviewed scientific journal, according to a Histogen spokeswoman. “We are not releasing an announcement at this time,” she adds.
Yet Histogen has summarized its early findings on its website, where a PDF copy of the May 12 poster also can be downloaded. The company says 56 patients were enrolled in 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.”