Dr. Gail Naughton of Histogen has agreed to do a small Q&A with our community. The Q&A will be limited to approximately 10 questions. Forum members are welcome to submit your questions in this thread, in an orderly fashion. Kindly note that Dr. Naughton has NO OBLIGATION to answer each and every question submitted here. Please be respectful with your questions and stay on topic.
For those who are not familiar with Histogen’s Hair Stimulating Complex (HSC) clinical trial, please read the following press release.
Histogen Hair Regrowth Clinical Trial Presented at ISHRS Annual Meeting
Data shows statistical significance at three key efficacy endpoints
SAN DIEGO, July 27, 2009 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, shared the results of the Company’s preliminary clinical trial of Histogen’s HSC human hair regrowth product for the first time at the International Society of Hair Restoration Surgeons (ISHRS) Annual Scientific Meeting. Dr. Craig Ziering, founder of Ziering Medical and principal investigator on the clinical trial, addressed attendees on July 25th, 2009 during the conference, taking place in Amsterdam July 22-26, 2009.
Patients treated with Histogen’s Hair Stimulating Complex (HSC)
Hair count + 22.4%
Terminal hair + 27.8%
Thickness + 23.9%
Hair count + 23.7%
Terminal hair + 24.2%
Thickness + 22.2%
HSC is a proprietary formulation of naturally secreted embryonic proteins, growth factors and contains the first naturally stabilized, bioactive solution of Wnt proteins and their cofactors, which have been implicated in the induction of new hair follicle formation and growth.
The five-month double-blind, placebo-controlled clinical trial was focused on evaluation of safety in the clinical application of Histogen’s Hair Stimulating Complex (HSC), formerly known as ReGenica. The 24 subject clinical trial was designed to examine the safety and efficacy of a single injection of HSC alone, as well as in combination with three different perturbation methods. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy.
Efficacy at 12 weeks with one Application of HSC
cumulative thickness density (mm/cm2) p=0.0249
thickness mean (um) p=0.0402
terminal hair density (n/cm2) p=0.0029
84.6% of the patients receiving one injection of Histogen’s serum-free HSC showed an increase in terminal hair 12 weeks post-injection, with a statistically significant (p<0.05) increase in the number of terminal hairs, cumulative hair thickness density and hair thickness mean. Perturbation did not enhance the results seen with HSC. There were no adverse reactions seen in any of the treated 24 patients at baseline, 12 weeks, or the 22 week endpoint.
“We are excited that our trial demonstrated safety and efficacy of our HSC product, which contains Wnt proteins and other growth factors important to hair follicle maintenance and growth,” said Dr. Gail K. Naughton, CEO of Histogen. “Wnt signaling has been shown by a number of experts in the field to be responsible for initiating epidermal stem cells to form new hair follicles in mice, and to be important in maintaining the hair inducing activity from existing follicles. Histogen’s trial is the first demonstration that compounds containing bioactive Wnt increase hair growth in humans.”
While additional clinical evaluation is needed to further examine product safety, efficacy and treatment specifications, the preliminary clinical trial of HSC represents a potentially significant new treatment option for the millions suffering from hair loss. Of the 87 million people in the United States that suffer from hair loss, it is estimated that only 2-7% seek surgical or pharmacological treatment. The same is true internationally due to the general lack of effective medical options for this widespread condition.
“Hair restoration treatments range in effectiveness and invasiveness. All of the current treatment options share the common goal of saving and redistributing existing hairs,” said Dr. Craig Ziering. “For the millions of men and women who grapple every day with their hair loss, the results of our HSC trial indicate the potential for a phenomenal treatment option that stimulates growth of new hairs along with increasing the thickness of existing hairs. Histogen’s HSC represents a potentially major paradigm shift from conventional treatment options to one that can promote the growth of new or dormant hairs using principles of the body’s own regenerative mechanisms.”
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen’s proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.