Biotech Co. Submits CTA for its 2nd Trial Launching in 2015

Written by Lee Buckler

RepliCel’s autologous cell therapy, RCS-01, to be investigated as a potential treatment for aged and UV-damaged skin.

RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP) today announced the submission of a Clinical Trial Application (CTA) to the German Competent Authority, the Paul-Ehrlich-Institut (PEI), requesting clearance to initiate a Phase 1 clinical trial investigating the use of RCS-01 to treat patients suffering from aged and UV-damaged skin. RCS-01 is a cell-based product highly expressive of type 1 collagen comprised of autologous, cultured fibroblast cells isolated from the non-bulbar dermal sheath (NBDS) of the hair follicle.

“RCS-01 is the second product, utilizing our hair follicle-derived fibroblasts, that we anticipate entering clinical testing in 2015 – the first being RCT-01 for chronic tendinosis. While the primary endpoint of this trial is to demonstrate the safety of RCS-01 injections into the skin, the trial is also designed to collect quantitative and qualitative data demonstrating the product’s effects, at a molecular level, on skin aging and UV-damage,” stated David Hall, RepliCel’s CEO. “This fibroblast-based program should be viewed as a broad platform which we will apply to multiple indications characterized by tissue damage and incomplete healing. We anticipate data from these NBDS trials (RCS-01 and RCT-01) will contribute to the early establishment of the commercial value of our fibroblast platform.”

“Initiation of this trial is another milestone in our 18-month strategy to create maximum value around the company’s fibroblast program,” stated Lee Buckler, RepliCel’s Vice-President of Business and Corporate Development. “In addition to our clinical trial programs, our team is working on manufacturing optimization involving state-of-the-art bioreactor technology and serum-free media, development of a proprietary injector device to reduce the human variability of our product injections, and pre-clinical research validating the immune-privilege of both our cell platforms in order to support the potential for allogeneic use of RepliCel’s products.”

Further details of the clinical program evaluating intra-dermal injections of RCS-01 will be provided once it has been cleared by the PEI.

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