Histogen Announces Start of Hair Regrowth Clinical Evaluation
SAN DIEGO, November 20, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced the start of the Company’s first human clinical evaluation of ReGenicaTM for hair regrowth. The primary objective of the study is to evaluate safety in the clinical application of the ReGenica product.
ReGenica is a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment, and then harvesting the naturally secreted growth factors, anitoxidants and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of wnt proteins and natural cofactors, which are thought to act in the formation of new hair follicles.
Histogen’s in-vitro and preclinical research to date has shown ReGenica to be safe, and has indicated the complex’s ability to increase hair growth and new follicle formation. Based on the results of preliminary research, and the potential of ReGenica as a hair regrowth treatment, Histogen has moved forward with this outside-U.S. study to more rapidly obtain human safety data which will allow the Company to progress with product development.
We are excited to be on schedule with the initiation of our first human clinical evaluation of ReGenica for hair growth,” said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. “We look forward to the results of this preliminary safety evaluation, which we can parlay into further studies.”
The ReGenica study, which began today, will be a double-blind, placebo-controlled, randomized single site study. Dr. Craig Ziering, renowned hair transplant surgeon and founder of Ziering Medical, is serving as Principal Investigator on the study with Dr. David Perez-Meza as Sub-Investigator. Results of this first human hair regrowth product clinical evaluation will be released by Histogen in the first half of 2009.
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 ReGenica, Histogen’s proprietary liquid formula. For more information, please visit http://www.histogeninc.com.