carrying on development of its hair regrowth treatment. The short version, for all the readers out there hoping for better treatments, is that Histogen (if it can survive) is planning to conduct additional clinical trials of its hair regrowth product in Singapore. Those experiments are expected to take about two more years. But even if regulators approve this particular treatment, it will only be available in parts of Asia—not the United States.
In our conversation, Naughton highlighted these key points:
—The initial experiment testing the HSC treatment was done in Honduras. Naughton says there were no safety issues “clinically or histologically.” She says Histogen is expected to report results from a 1-year follow-up of the Honduras study by the end of this month, and the one-year data will be submitted to the International Society of Hair Restoration Surgery’s professional journal.
—Histogen plans to enroll 50 patients in another HSC experiment that will be done in Singapore. This study will begin “no later than June,” according to Naughton, who notes that Singapore has become a mecca for aesthetic and cosmetic medical treatments.
—Providing that the Singapore study is successfully completed, Naughton says Histogen plans to conduct a late-stage clinical trial of its hair regrowth treatment that will enroll between 200 and 250 patients from Hong Kong, India, South Korea, and Singapore. She says the trial is scheduled to begin in spring 2011. “If everything goes well,” Naughton says, “we expect to get pan-Asian approval [for the HSC treatment] everywhere but Japan.”
—Histogen plans to begin two additional pilot trials of HSC as a topical treatment (with no injections below the skin) in the United States over the next six months. Dr. Craig Ziering, a Southern California hair transplant surgeon, will oversee the tests. Ziering, an osteopath who has offices in Beverly Hills, Newport Beach, La Jolla, Las Vegas, NV, and Salt Lake City, UT, also sits on Histogen’s scientific advisory board. Naughton says one of the studies will apply HSC to transplanted hair follicles and is intended to test its suitability in preventing hair loss. The other U.S. study calls for applying HSC on scar tissue from previous hair transplant procedures.
So how is Histogen going to pay for all these clinical trials? Naughton says the startup also has made progress on that front, but she’s not ready to talk about it just yet. Standby for more news from Histogen in the weeks to come.
