PRZOOM - /newswire/ -
Winston-Salem, NC, United States, 2012/04/24 - SmallCapReview, A leading site for news and information on small caps, penny stocks and microcaps is adding Replicel Life Sciences (REPCF) to its list of stocks "On the Radar" - SmallCapReview.com.
RepliCel Life Sciences reported earlier this month that they expect to receive the first human Phase I/IIa trial results data on the world's first real cure for hair loss in men and women by the end of this month.
RepliCel was founded to advance the breakthrough findings of Dr. Kevin McElwee and Dr. Rolf Hoffmann, established research scientists in the fields of immunology, hair biology, hair growth, and dermatology. In the early 2000s, at Phillips University in Marburg, Germany, these doctors discovered that dermal sheath cup cells have the ability to initiate cellular growth of mature hair follicles in animals.
The scientists’ landmark study titled,"Cultured Peribulbar Dermal Sheath Cells Can Induce Hair Follicle Development and Contribute to the Dermal Sheath and Dermal Papilla," was published in the peer-reviewed Journal of Investigative Dermatology in 2003 and forms the basis of both the RepliCel™ technology and the patent filings.
RepliCel is now developing this discovery as a potential successful treatment for hair loss in humans.In addition to the discovery of the critical cell population believed to be responsible for hair follicle growth, RepliCel has created a proprietary method for extracting and replicating these cells, with the goal of developing a safe, minimally invasive procedure for inducing natural hair growth in men and women suffering from various types of hair loss.
The RepliCel™ procedure has shown significant promise in standard pre-clinical animal trials. The procedure is now undergoing rigorous human studies to establish safety and determine effectiveness. RepliCel began their first human clinical trial (Phase I/IIa) in the country of Georgia in December 2010. To date, there have been no adverse effects reported.
Initial results from this clinical trial are expected to be released in April 2012. Data from this clinical trial will be used for the development of a Phase IIb dose-ranging clinical trial of 100 patients which is expected to commence in the fall of 2012 in Europe and/or North America.
Patents for the technology are now issued in the Europe Union and Australia and are pending in the US, Canada, and Japan.
REPCF Investor Highlights
Recently reported that all 19 subjects have completed their six-month post injection follow-up visit and the company remains on schedule to release the initial review of efficacy results in April 2012.
The initial data from RepliCel's 6-month subject follow-up will be used in the Company's Investigational Medical Product Dossier (IMPD), which is presently being developed for a Phase IIb dose-ranging clinical trial of 100 patients that is expected to commence in fall 2012.
To date, no serious adverse events have been reported post injection in any of the 10 men and 9 women participating in the study.
RepliCel began conducting a ‘first-in-man’ clinical trial in December 2010 to study the safety and efficacy of its procedure to potentially treat androgenetic alopecia.Pre-Clinical process was proven safe and highly effective in the standard research Philpott SCID Mice model.
RepliCel has entered into a three year collaborative research agreement with First Affiliated Hospital of Sun Yat-Sen University in China and its head of Dermatology, Dr. Xingqi Zhan, for the development of cell culture methodology for mesenchymal hair follicles. The research will involve blinded studies on optimizing cell culture.
Based at established universities in Canada and Germany, RepliCel’s scientific founders and research scientists have studied immunology, hair biology and hair growth for more than two decades. This respected team has developed a strong scientific understanding of the mechanisms underlying alopecia.
Collectively, the company’s scientific founders and research scientists are highly published in peer-reviewed scientific and medical publications in the areas of immunology, hair biology, hair growth, alopecia, hair follicle endocrinology and morphogenesis and clinical dermatology.
Patents are now issued in Europe and Australia and are pending in the US, Canada, and Japan.
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