Histogen added the following update re: the AAD conference to their site recently:
Histogen Hair Regrowth Clinical Trial Results to be Presented at AAD Annual Meeting
SAN FRANCISCO, March 7, 2009 - Attendees of the American Academy of Dermatology Annual Meeting, taking place March 6-10, 2009 in San Francisco, will receive a peek of Histogen’s preliminary hair regrowth clinical trial results in two presentations during the event. Data will be shared within an electronic poster from Histogen throughout the event, as well as within a podium presentation being given by Dr. Kenneth Washenik on advances in the treatment of hair loss on Sunday, March 8th.
Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, has recently released data from the 12 week timepoint of the Company’s first human clinical evaluation of ReGenicaTM for hair regrowth. This clinical trial is the first time that a single application of a treatment has shown an increase in new follicles, thickness of existing hairs, and number of hairs in pre-existing follicles, in a human study.
ReGenica, a proprietary liquid containing naturally secreted embryonic proteins and growth factors, is the first naturally stabilized and bioactive formulation of Wnt proteins and natural cofactors, which have been implicated in the formation of new hair follicles.
“It is definitely exciting to see the laboratory promise of Wnt’s effect on hair growth successfully translated into a clinical study,” said Dr. Washenik, who is the Medical Director of Bosley, the nation’s largest hair restoration group, and a faculty member in the Department of Dermatology at NYU’s School of Medicine.
Histogen scientists reported on the upregulation of several Wnt genes in response to the embryonic conditions in the Company’s proprietary bioreactors. In addition, the data has confirmed the activity of these Wnt proteins, through the nuclear translocation of beta catenin in human keratinocytes, the downstream signaling of Wnt-responsive TCF/ Lef promoter, and the presence of secreted Wnt 7a through western blot analysis.
Histogen began its outside-U.S. clinical trial 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. Dr. Craig Ziering, the principal investigator on the trial, is a leading hair transplant specialist and the founder of Ziering Medical.
“For the millions of men and women who grapple every day with their hair loss, the results of our early testing indicate the potential for a phenomenal treatment option, particularly for women and men presenting with diffuse hair loss who are not good candidates for hair transplant surgery,” said Dr. Ziering. “In addition to growing new hair, it increases the diameter of existing hair, creating more volume and coverage, which are the primary goals of those seeking help for their thinning or balding hair.”
The trial is currently in progress, with the final scheduled 5 month timepoint upcoming. The Company expects to release full results from this first clinical trial in the first half of 2009.
Histogens’ electronic poster presentation, entitled Tissue-engineered human embryonic-like conditioned media for therapeutic applications, will be available for viewing throughout the American Academy of Dermatology Annual Meeting.
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 ReGenica, Histogen’s proprietary liquid formula.