RepliCel Provides Update on First-in-man Clinical Trials and Recent Corporate Activity
(firmenpresse) - VANCOUVER, BRITISH COLUMBIA -- (Marketwire) -- 11/01/11 -- . (the "Company" or "RepliCel") (OTCBB: REPCF) held its annual meeting of shareholders on Thursday, October 27, 2011, which included an update on recent corporate events.
TS001-2009 Clinical Trial Update
RepliCel is now well into the post-injection follow-up period of its TS001-2009 clinical trial. Subjects are returning to the study centre to have their overall health assessed, as well as to have subjective and objective assessments of the areas that were injected either with verum or placebo. To date, no serious adverse events have been reported post injection in any of the 10 men and 9 women in the study. Digital images are being taken of the scalp to assess any changes post-injection and the differences in health and hair growth between the two treatment areas. RepliCel remains on-track to issue results from all 19 subjects' six-month follow-up visit in March/April 2012. Subjects will continue to participate in the post-injection follow-up period of the study until August 2013 and final analysis of safety data should be available in late 2013.
Data from RepliCel's 6-month patient 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. The protocol will be run through the EMEA, FDA and Health Canada. A final decision on the location of the trial is pending.
Collaborative Research Agreement
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.
Press Coverage
In September 2011, RepliCel President and CEO, David Hall, was interviewed by Spencer Kobren of The Bald Truth, America's longest running radio talk show for balding men. Excerpts from this interview were featured on the and the full interview can be heard on .
On October 18, 2011, RepliCel was featured on , a website dedicated to providing research on healthcare issues. The article titled, RepliCel's Cell-based Solution to Hair Loss can be viewed at . On the same day, Standard & Poor's commenced on the Company. RepliCel's 10-page report will be updated weekly by S&P and is accessible to a wide audience of Buy and Sell-side investors and millions of self-directed investors.
Earlier in the week, Equities.com wrote an editorial piece titled, .
Tammey George, Director of Communications comments, "The hair loss and investment community is becoming aware of RepliCel's hair cell replication technology. We are seeing significant increases in our website traffic and increased dialogue on our social media platforms. RepliCel's corporate videos have received over 10,000 hits combined and can be viewed at ."
About RepliCel Life Sciences
The Company has developed RepliCel™, a natural hair cell replication technology that has the potential to become the world's first, minimally invasive solution for androgenetic alopecia (pattern baldness) and general hair loss in men and women. RepliCel™ is based on autologous cell implantation technology that replicates a patient's hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, the Company hopes to initiate natural hair regeneration. Patents for the technology have been issued by the European Union and Australia and are pending in other major international jurisdictions. The RepliCel™ procedure has been developed over the past nine years by the Company's recognized research scientists and medical experts - specialists in the fields of hair growth, hair biology and dermatology. Additional information on RepliCel is available at .
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements that relate to the Company's expected timeline regarding the timing and objectives of the interim analysis to be completed after the completion of the final patient's six month follow-up visit, the participation of subjects after completion of such analysis and the timing of the expected commencement of the Company's Phase IIb clinical trial. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including: negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2010 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at and with the British Columbia Securities Commission on Sedar at .
Contacts:
RepliCel Life Sciences Inc.
Tammey George
Director of Communications
604-248-8696
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Datum: 01.11.2011 - 08:00 Uhr
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