RepliCel Life Sciences Announces Completion of last injection as part of its clinical study of tendon repair
First safety and clinical efficacy data of RCT-01 study will be available in December for analysis
VANCOUVER (BRITISH COLUMBIA), August 11, 2016. RepliCel Life Sciences Inc. (OTCQB: REPCF; TSX-V: RP; Frankfurt: P6P1) ( "RepliCel" or the "Company"), a regenerative medicine company, located is in clinical stage and is focused on developing autologous cell therapies, today announced that it has completed the last injection as part of its clinical Studio on RCT-01 concerning the treatment of patients with chronic Achillestendinopathie. The last scheduled patient visit to receive data after the treatment will take place in late November.
The safety and six-month effect data from the study are expected to be performed unblinded and be provided until the end of analysis and publication. As part of the follow-up of patients after injection numerous measurements are taken in terms of efficacy, including functional and pain scores and ultrasound images of the treated tendon.
"This study is a Phase 1 safety study to monitor and measure certain indication of effectiveness, however, statistically not suitable for efficacy data. We are looking for a convincing signs in at least some of the patients that the product with regard to the restoration of functioning, the pain relief and / or the regeneration based measured by ultrasound images tendon structure is clinically relevant, "said Dr. Rolf Hoffmann, Chief Medical Officer of RepliCel.
The data on the effectiveness of the treatment will provide information and benchmarks for the company's strategy in terms of product development and clinical trials - not only for the Achillestendinopathie, but also for numerous other tendon repair applications, including the treatment of Springer knee, Golferarms, the tennis elbow and rotator cuff ,
"We are confident that the data collected by the end of safety and preliminary efficacy data will represent a signal of the potential of the product, to reconstruct chronically injured tendons, which was not possible with other treatments. This will enable our team to plan the next steps for this asset, both clinically and commercially ", R. Lee Buckler, President and CEO of RepliCel.
"Positive safety data and an indication of the efficacy in this study will help the company to continue in 2017 with a study of the next phase, and could also bring the opportunity to be a licensing and / or developing cooperation agreement with a major partner to sign, "Buckler said.
RCT-01: tendon repair
RCT-01 is a proprietary cell therapy product consisting of non-bulbar Hautmantel- (NBDS) cells. Itinvolves collagen donating type 1 fibroblasts derived from hair follicles. When carried out in a single study center Phase 1 / Phase 2 study, which is currently in Vancouver (British Columbia) under way, the use of RCT-01 to treat chronically injured ankle tendon (Achilles tendon) which also Achillestendinopathie examines is called or tendinosis.
About the NBDS fibroblast platform RepliCel
The NBDS fibroblasts platform RepliCel has the potential to be suitable for a number of indications in which the tissue healing was reduced due to a lack of active fibroblast cells that are required for tissue remodeling and reconstruction. The own NBDS fibroblast cells of RepliCel that are isolated from healthy hair follicles, are a rich source of fibroblasts due to their high content of necessary proteins - are unique - such as type 1 collagen, which is needed to kick-start the delayed healing process , The company developed a number of products of this platform, which have the potential, large commercial markets in the field of musculoskeletal and to target skin diseases. To learn more about RepliCels RCT-01 treatment of chronic tendinosis, look at our video: www.youtube.com/watch?t=23&v=kaa0hiJyeV4
About RepliCel Life Sciences
RepliCel is a regenerative medicine company that is focused on the development of autologous cell therapies, which are suitable for conditions due to a lack of healthy cells that are needed for normalionstchtigkeit healing and Sparks. The product pipeline includes two ongoing clinical trials (RCT-01: tendon repair and RCS-01: Skin Rejuvenation) and the product RCH-01: hair restoration, for which theShiseido Company holds an exclusive license for certain Asian countries.
All product candidates are based on the innovative technology of RepliCel using cell populations that are isolated from healthy hair follicles of the patient. The company also developed its own injection unit (RCI 02), which has been optimized for the administration of its products and can also be licensed for use with other dermatological applications. For more information, please visit www.replicel.com .
For further information, please contact:
COMPANY:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com
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Forward-Looking Statements
This press release contains forward-looking information that involve various risks and uncertainties regarding future events in themselves. Such forward-looking information may include statements, including but not limited to, in terms of current expectations that involve a number of risks and uncertainties and no guarantees of future performance of RepliCel represent, such as statements regarding the Company's ability carry out orto sign a licensing and / or developing cooperation agreement with a major partner in 2017 a study of the nextphase. Such forward-looking statements and information are based on current expectations that involve a number of risks and uncertainties and are not guarantees of future performance of RepliCel. There are numerous risks and uncertainties that could cause differ materially actual results and plans and objectives of RepliCel materially from those expressed or implied in the forward-looking information, including: the inability approval of the CE marking, or to obtain required regulatory approvals; Delays in the registration of participants in the clinical trial; negative results of studies of the company; the impact of government regulations on the Company's business; Risks relating to the company's ability to obtain rights to its intellectual property and to protect; Risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Actual results and future events could differ materially from those expressed or implied by such information. These and all subsequent written and oral forward looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. RepliCel is not obligated to update these forward-looking statements - unless this is required by law.
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