HISTOGEN TO PRESENT PRELIMINARY HAIR REGROWTH CLINICAL RESULTS AT STEM CELL SUMMIT
Hair Stimulating Complex (HSC)
Histogen’s Hair Stimulating Complex (HSC) is a proprietary liquid formula created by the culturing of newborn cells in a simulated embryonic environment of suspension and very low oxygen, and then harvesting the naturally secreted growth factors, proteins and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of Wnt proteins and their cofactors, which have been implicated in hair follicle development and growth.
Histogen’s HSC is currently being developed and evaluated as an injectable for hair growth. The combination proteins and growth factors, including Wnts and follistatin, making up the formulation have been shown to both stimulate resting hair follicles and induce new follicle formation.
HSC Clinical Development
The pilot 24 subject clinical trial of HSC was a double-blind, placebo-controlled evaluation of safety in the clinical application of the product as an injectable for hair growth. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy. No adverse events were seen at any timepoint, including the one year follow-up. HSC also achieved statistical significance in its efficacy endpoints, including hair count, hair thickness, and hair density at the 12 week endpoint and patients continued to see statistically significant additional growth at 12 months, even though they received only one treatment at baseline.
For the latest information on Histogen’s hair regrowth pilot clinical trial, please visit our news page: www.histogen.com/aboutus/news_events.htm#25
The next clinical trial of HSC is currently in planning stages, and is scheduled to begin in Singapore in early 2011, with plans for pan-Asian approval in 2014. Estimated U.S. market introduction of the injectable for hair regrowth in the treatment of male pattern baldness is 2015, with potential for earlier introduction in certain identified countries.
Market Capabilities for Hair growth
While additional clinical evaluation is needed to further examine product safety, efficacy and treatment specifications, the pilot 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.
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 – ExceltrixTM, Histogen’s human Extracellular Matrix (ECM) and ReGenicaTM, Histogen’s proprietary liquid formula. For more information, please visit http://www.histogeninc.com.