Histogen Announces Initial Results from Phase I/II Clinical Trial of HSCData shows significant efficacy at all time points and all treated hair loss regions
SAN DIEGO, October 19, 2012 - Histogen, Inc., a regenerative medicine company developing innovative therapies based on the products of cells grown under simulated embryonic conditions, will present preliminary data from the ongoing clinical trial of its Hair Stimulating Complex (HSC) today at the International Society of Hair Restoration Surgery (ISHRS) Annual Meeting. Statistically significant improvement was seen across all targeted hair growth parameters in this Phase I/II clinical trial, with an 86% responder rate.
The double-blind Phase I/II clinical trial was undertaken to further examine the safety and efficacy of intradermal injections of HSC in 56 men with androgenetic alopecia. In addition to other safety outcome measures, clinical evaluation of blood serum chemistry, hematology and urinalysis showed no indication of toxicity over 12 weeks. The treatment was well-tolerated and no study-related adverse events have been reported.
In this second clinical trial of HSC, which was designed with an additional treatment timepoint, the increase in total hair count was 46.5% above that seen in the pilot HSC trial at 12 weeks. Statistical significance was noted in all efficacy endpoints, which include increases in total hair count (p=0.0013), terminal hairs (p=0.0135), and hair thickness (p=0.026). A significant increase in vellus hair count (p=0.033) was seen for the first time, supporting the hypothesis that the HSC treatment rescues dying follicles, in addition to converting vellus to terminal hairs and increasing the number of hairs per follicle. Statistical significance continued to be seen at the 24 week time point.
"We are excited that HSC has not only continued to show unprecedented results, but that the addition of a second treatment time point in the Phase I/II clinical trial has resulted in even greater hair growth than the pilot study," said Gail K. Naughton, Ph.D., Histogen CEO and Chairman of the Board. "Particularly compelling is the growth seen in more difficult types and stages of hair loss. Without limitations to treatment area, age or stage of balding, HSC has the potential to expand the hair restoration market by offering a successful option to those that currently have none."
Available non-surgical treatment options for alopecia focus on younger patients in the earlier stages of hair loss, with a primary purpose of retaining existing hair and supporting limited hair regrowth. This is not the trend seen in the clinical trials of HSC. In both the pilot and Phase I/II clinical trial, HSC treatment has shown efficacy across age groups, with subjects age 40-59 seeing cosmetically significant results beginning at 12 weeks, including a mean increase of 39% in terminal hairs and 19.4% in total hair count in this age group in the current trial.
Importantly, the efficacy of HSC is not limited by hair loss region. The Phase I/II clinical trial has shown noted new hair growth in subjects treated in all regions of the scalp, including temporal recession, mid-scalp and vertex. Subjects receiving HSC in the temporal recession, which is known to be more difficult to treat than other areas of hair loss, saw marked improvement in terminal hair count, with a mean increase of 22.6% at 12 weeks and 25.2% at the 24 week time point.
In addition to the Phase I/II data, Dr. Naughton will present results from a Physician-sponsored IND of HSC conducted by Dr. Craig Ziering, an ISHRS member and leading hair restoration surgeon. Five men and five women received up to four treatments of HSC, with all subjects showing positive hair growth. Increased hair growth was seen as early as 6 weeks, with clinically and cosmetically relevant results seen as early as 18 weeks.
"The clinical data seen to date with HSC is very compelling," said Dr. Craig Ziering, Founder and CEO of Ziering Medical. "Not only is the strong safety profile clinically important, but we have seen cosmetically significant results, with coverage of thinning areas, in a clinical setting. In addition, the response seen in women treated with HSC is unprecedented."
HSC is a complex of proteins and growth factors naturally secreted by multipotent cells under Histogen's proprietary growth conditions. The proteins within HSC, such as KGF, VEGF, and follistatin, are involved in signaling stem cells in the body, and have been shown to be key in hair formation and the stimulation of resting hair follicles.
"Scalp Injection of Active Embryonic-like Cell-secreted Proteins and Growth Factors" will be presented by Dr. Naughton at the ISHRS Annual Meeting, taking place October 17-20, 2012, in the Bahamas.
