VANCOUVER, BC – April 3, 2012 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) is pleased to report 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 data collected from the first six months following injection will be used for assessment of the primary safety and secondary safety and efficacy endpoints for the TS001-2009 clinical trial.
In March and throughout the month of April 2012, the TS001-2009 study team will be retrieving data from the study centre in Tbilisi, Georgia and sending it to an independent clinical research organization data management team in Munich, Germany. Once received, it is entered into a database and reviewed for any anomalies in the collected data. These anomalies are then sent to the study centre for clarification and/or correction. These standard reviews ensure accuracy in the information collected for the study.
The TS001-2009 study is being conducted in a placebo-controlled and ‘blinded’ fashion; that is, neither patient, nor assessor is aware of what site received injections of placebo or active treatment with cells. This blinding is maintained throughout the data collection, entry, and cleaning process as the treatment assignments are maintained by an independent party removed from patient assessment or data management. Only when all reviews have been completed and queries answered, the database containing the collected information will be ‘locked’ (a state where information in the database is final) and the treatment assignments revealed (also referred to as ‘un-blinding’).
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 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 www.replicel.com.
For more information please contact:
Tammey George, Director of Communications
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.