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RepliCel Completes First Pre-Filing Review with German Competent Authority on its RCH-01 Autologous Hair Cell Manufacturing Process
Phase II Dose Ranging Trial on its Hair Cell Replication Technology Expected to Commence Mid-2013
By: Marketwired .
Nov. 7, 2012 02:19 PM
VANCOUVER, BRITISH COLUMBIA -- (Marketwire) -- 11/07/12 -- RepliCel Life Sciences Inc. (OTCBB:REPCF) (the "Company" or "RepliCel") is pleased to report on its pre-filing scientific meeting with the German Competent Authority responsible for cellular therapies - the Paul Ehrlich Institute (PEI).
During the latter part of 2012, the Company has been making enhancements to the RepliCel(TM) procedure to improve the quality, characterization, and shelf-life of its autologous hair cell product which has been named RCH-01. RepliCel's scientific team met with experts from the PEI on November 2, 2012 to discuss these important revisions and to receive guidance on its proposed current Good Manufacturing Practice (cGMP)-compliant manufacturing process and product specifications that will be used in the conduct of RepliCel's upcoming Phase II, dose-ranging clinical trial. The PEI experts agreed that the proposed manufacturing process for RCH-01 is acceptable for the conduct of a Phase II study and recommended some additional validation work on the manufacturing process be included in the investigational medicinal product dossier (IMPD) that forms part of the clinical trial application.
The results achieved at this meeting have laid the groundwork for the next pre-filing meeting with PEI experts during which time RepliCel's scientific team will discuss the design and methodology of its Phase II clinical trial to be implemented in Germany. This trial is designed to confirm the efficacy of injections of RCH-01 in over 100 male participants. In addition to augmenting the Company's information on the safety of injections of RCH-01, the trial will also provide insight into the optimal treatment regimen for hair growth. The meeting with the PEI, and subsequent confirmation of the design of the Phase II clinical trial, will be completed prior to the end of 2012.
RepliCel's scientific team anticipates the non-binding recommendations received at these meetings, in advance of submitting the formal clinical trial application, will help ensure that all regulatory requirements are met in order to facilitate a smooth review, approval, and implementation of future clinical research. The Company anticipates initiation of the Phase II study by mid-2013.
"We are pleased with the direction and counsel offered by the experts at the PEI," stated Darrell Panich, RepliCel's VP Clinical Affairs. "Our next step is to reappear before a different panel of experts at the PEI next month to obtain counsel that will assist us in finalizing the clinical design which will allow us to complete our application. We are delighted to be one step closer to the initiation of our Phase II trial."
About RepliCel Life Sciences
The Company has developed RepliCel(TM), a natural hair cell replication technology that has the potential to become the world's first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. RepliCel(TM) 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(TM) procedure has been developed over the past ten 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 www.replicel.com.
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 and include that RepliCel(TM) has the potential to become the world's first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women and that RepliCel will initiate the Phase II study by mid-2013. 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 inability to meet the proposed timeline for 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 statements speak 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, 2011 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
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