Is Histogen Hair to Stay? Amid Patent Lawsuit That Is Mane Event, CEO Updates Plans to Advance its Hair Regrowth Treatment
San Diego-based Histogen became something of a high-wire act on the local biotech scene last year after a cross-town rival filed a patent infringement lawsuit against the startup—upending Histogen’s plans to develop a variety of regenerative medical treatments.
The patent suit, which was filed a year ago by Carlsbad, CA-based SkinMedica, hit just as Histogen was preparing to report early results of its experimental treatment to stimulate hair regrowth among 24 men with male-pattern baldness. As we reported at the time, the prospect of costly litigation prompted a group of angel investors to withdraw their planned $2.4 million investment, and Histogen was forced to lay off all 36 employees.
At that time, it seemed likely that the teetering startup was headed for a fall, and Histogen would soon be history.
That still could be the outcome. Lawyers for Histogen filed a request for a summary judgment last August that would dismiss the case. Lawyers for SkinMedica filed their response in September, arguing to keep the lawsuit on track and headed for trial. I reviewed the filings in San Diego federal court yesterday, and U.S. District Judge Thomas J. Whelan has yet to rule on the arguments over Histogen’s bid for an early dismissal.
Meanwhile, as I reported in an end-of-the-year summary, many Xconomy readers continue to root for success in Histogen’s experimental treatment for male pattern baldness.
But we haven’t heard much from Histogen since July, when the startup reported final results of its early study. In the experiment, a single injection of the company’s hair regrowth product—formerly known as ReGenica, now called Hair Stimulating Complex, or HSC—was made just beneath the scalp. Histogen says nearly 85 percent of the two dozen balding men had more hair three months after being treated, and they experienced an increase in hair thickness and density.
To get an update, I recently spoke by telephone with Histogen CEO Gail Naughton, who highlighted the company’s latest plans for 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.