RepliCel Life Sciences
OTCQB : NCSLF

RepliCel Life Sciences

May 17, 2011 09:01 ET

RepliCel Update on First-In-Human Clinical Trial TS001-2009

VANCOUVER, BRITISH COLUMBIA--(Marketwire - May 17, 2011) - RepliCel Life Sciences(1)(the "Company" or "RepliCel") (OTCQB:NCSLF) is pleased to provide an update on its first-in-human clinical trial TS001-2009. As of today, all 20 subjects have been enrolled in the study and have provided biopsy samples for processing using the proprietary RepliCel™ technology. Furthermore, the first injection of hair follicle cells prepared using RepliCel™ technology was completed on March 10, 2011. The final injections of hair follicle cells are anticipated to take place before the end of July 2011.

The first injection of hair follicle cells represented the beginning of the next stage of the TS001-2009 study. In this stage, the post-injection follow-up period, subjects return to the study centre to have their health closely monitored to ensure that there have been no adverse effects associated with receiving the injections and to determine the hair growth stimulating efficacy of the hair follicle cell injections.

All subjects are expected to complete their six-month follow-up visit by the end of January 2012. Once the final patient has completed their six-month follow-up visit, an interim analysis of all collected data will be performed to assess the primary outcome measure of the TS001-2009 study. The analysis will involve assessment of the local (at treatment sites) safety profile of autologous hair follicle cells compared to placebo as defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness. Secondary outcome measures of systemic (overall) safety (through review of adverse events in a similar fashion as described above) and efficacy (hair growth at treatment sites) will also be performed at this time. Data from the interim analysis should be available for review in early 2012. Subjects will participate in the follow-up period of the study until July 2013 and final analysis of data should be available in Q3 2013.

TS001-2009 Clinical Trial Overview

The TS001-2009 clinical trial is designed to test the safety and efficacy of the RepliCel™ technology in men and women with androgenetic alopecia. This single-centre study enrolled 20 subjects with alopecia categorized as either vertex pattern type II or type III on the Ludwig Scale (female) or as type III vertex to type VI on the Norwood Scale (male). At the beginning of the trial, subjects provided blood samples to confirm their health status and biopsies were taken from their scalps from which hair follicle cells were/are being processed using RepliCel™ technology. Once cell processing is complete, subjects return to the study centre to have baseline measurements of their overall health and the health of their scalps. They then receive injections of their own replicated cells (autologous cells) in medium (verum) and medium alone (placebo) into two pre-selected treatment areas in their scalps.

In the follow-up period, subjects return to the clinic for 10 visits over the next 24 months. At these visits, subjects have their overall health assessed, as well as subjective and objective assessments of the areas that were injected either with verum or placebo. Digital images will be taken of the scalp to assess any changes to the scalp post-injection and the differences in health and hair growth between the two treatment areas. Furthermore at 6, 12, and 24 months post-injection, four subjects at each time point will provide biopsies of the injection sites for histopathological analysis. The total duration of subject participation in the study is approximately 27 months.

About RepliCel Life Sciences

To properly reflect the Company's business focus, Newcastle Resources Ltd. is doing business as 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 www.replicel.com.

(1) Newcastle Resources Ltd. is doing business as RepliCel Life Sciences.

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 can include, without limitation, statements based on current expectations involving a number of risks and uncertainties which are not guarantees of future performance of the Company such as the statement that the RepliCel™ hair cell replication technology 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 and statements with respect to the anticipated timing for injections and data analysis. 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, including that the Company's hair cell replication technology may not work as planned or may not be effective at causing the re-growth of hair follicles or the rejuvenation of damaged, miniaturized follicles; the effects of government regulation on the Company's business; the viability and marketability of the Company's hair cell replication technology; the Company's failure to successfully implement its marketing plan; the development of superior technology by the Company's competitors; the failure of consumers and the medical community to accept the Company's technology as safe and effective; risks associated with the Company's ability to obtain and protect rights to our 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 Canadian Securities Commissions on SEDAR at www.sedar.com.

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