VANCOUVER, BC – January 30, 2012 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) is pleased to report that the six-month post injection follow-up period of its TS001-2009 clinical trial is nearing completion.
To date, 17 of 19 subjects have had their six-month follow-up visit, during which time subjects had their overall health evaluated. This included subjective and objective assessment of verum and placebo injected sites and digital images were taken of the scalp and injection areas. The digital images will be used to assess any treatment response and any post-injection changes in scalp health compared to baseline and between the two treatment areas. The remaining two patients are scheduled to complete their follow-up visits before the end of March. Four patients will complete 12-month follow-up visits in that same time frame.
To date, no serious adverse events have been reported post injection in any of the 10 men and 9 women participating in the study.
The TS001-2009 study team will be performing a thorough review of the collected study data throughout the months of March and April 2012. Once complete, the treatment groups will be revealed (‘un-blinded’) to the data analysis team and the data will be analyzed. RepliCel remains on schedule to release the initial review of efficacy results in April 2012.
Subject efficacy at 6-months post injection is the first step in measuring a treatment response. All subjects will continue to participate in the post injection follow-up period of the study until August 2013 and a review of final safety and efficacy results will commence before the end of 2013. The continued follow-up period is a key component of the study to confirm treatment safety profile and response trends at 6, 12 and 24 months.
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. The protocol will be submitted to the EMEA, FDA and Health Canada for review. A final decision on the location of the trial is pending.
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 and general hair lossin 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 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 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 www.sec.gov and with the British Columbia Securities Commission on Sedar at www.sedar.com.