Histogen, a regenerative medicine company focused on stimulating the body’s stem cells to regenerate tissues and restore youthful function, has received approval of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to study its lead product in female diffuse hair loss. The Company also received renewal of its clinical manufacturing license from the Food & Drug Branch (FDB) of the State of California this week.
Stimulating Complex (HSC660) is a soluble formulation of a subset of naturally-secreted growth factors developed as an injectable treatment for hair growth. Through Histogen’s patented technology process, fibroblast cells are induced to become multipotent stem cells, and there is upregulation of growth factors which have been shown to be important in hair viability. HSC660 is manufactured from the purification of cell conditioned media to enrich for these growth factors. Key growth factors within HSC660 include KGF, VEGF, and follistatin, which have been shown to be important in hair formation and the stimulation of resting hair follicles. Follistatin, in particular, has been linked to hair follicle stem cell proliferation.
“HSC660 is the first complex biologic consisting of a cocktail of naturally-secreted growth factors to be approved by the FDA as an investigational injectable treatment for alopecia,” said Dr. Martin Latterich, Histogen Vice President of Technical Operations. “After seeing promising results in early trials of our cell conditioned media, we are excited to launch our first Company-sponsored clinical trial of HSC660 in women.”
Pilot and Phase 1/2 Clinical Trials of an HSC660 predecessor were completed in male pattern baldness outside the US, with results that produced statistically significant efficacy indicators and a clear safety profile. More recently, a physician-sponsored 10 patient study in the US showed cosmetically significant results in both men and women. In addition to seeing a 100% female responder rate in the physician-sponsored study, previous trials have shown efficacy in other difficult-to-treat populations including men over 40 years of age and temporal recession hair loss.