|
Histogen to Present Preliminary Hair Regrowth Clinical Results
at Stem Cell Summit |
reprinted with
permission from Histogen
Company will Share Sneak
Peek at Safety and Efficacy Results from In Progress Clinical Trial
NEW YORK, February 16, 2009 – Dr. Gail Naughton, CEO
of Histogen, Inc., a regenerative medicine company developing
solutions based on the products of newborn fibroblasts grown under
embryonic conditions, will address attendees tomorrow at the 4th
Annual Stem Cell Summit in New York. Dr. Naughton will be presenting
preliminary mid-trial results from Histogen’s first human clinical
evaluation of ReGenicaTM for hair regrowth.
The primary objective of this double-blind, placebo-controlled,
randomized study is to evaluate safety in the clinical application
of the ReGenica product for hair regrowth. Histogen is also
examining product efficacy as a secondary objective, specifically
looking at the same end-points the Company has seen in the animal
model – new hair growth, and the thickness of new and existing hair.
The study is in progress, but the Company has reviewed data from the
scheduled 12 week time point and is pleased with the results to
date.
“Histogen’s clinical trial was designed to assess the safety of its
product over a five month period,” commented Dr. Craig Ziering,
principal investigator of the study and founder of Ziering Medical.
“In addition to seeing no adverse reactions, we were delighted to
see more hair, thicker hair shafts, and what appears to be the
growth of completely new hair follicles in the areas that received
the ReGenica treatment.”
ReGenica is a proprietary liquid formula created by the culturing of
newborn fibroblasts in an embryonic-like environment, and then
harvesting the naturally secreted embryonic wnt proteins, growth
factors, 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.
“Wnt signaling has been shown to be responsible for initiating
epidermal stem cells to form new hair follicles in mice, and is also
important in maintaining the hair inducing activity from existing
follicles,” said Frank Zeigler, General Manager at Histogen. “We are
excited to be the first group to show these effects in a clinical
setting using human WNT proteins.”
Histogen began this outside-U.S. study of ReGenica for hair regrowth
in November, with the goal of more rapidly obtaining human safety
data which will allow the Company to progress with product
development. The trial is currently ongoing, and Histogen expects to
release full results from this first clinical study in the first
half of 2009.
Dr. Gail Naughton has spent more than 15 years extensively
researching the tissue engineering process, and holds more than 90
patents in the field. Dr. Naughton founded Histogen in 2007, and
currently serves as Chief Executive Officer and Chairman of the
Board for the Company, in addition to her position as Dean of the
College of Business at San Diego State University.
BASELINE - Before
treatment
12 weeks
Side by Side Comparison
About Histogen
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, email
hairsite@aol.com
