View Full Version : Some news for you JFSI - not sure what it means though

11-07-2012, 06:31 PM
I have just received this email today from Replicel. I have read it and don't fully understand what they are saying, I am not sure if this is good news or if it is just a routine press release for Replicel to keep their name out there. It might be something you want to mention on the news for the week section of the show:

RepliCel Completes First Pre-Filing Review with German Competent Authority on its RCH-01 Autologous Hair Cell Manufacturing Process

Phase II Dose Ranging Trial on its Hair Cell Replication Technology Expected to Commence Mid-2013

VANCOUVER, BC - November 7, 2012 - RepliCel Life Sciences Inc. (the "Company" or "RepliCel") (OTCBB: REPCF) is pleased to report on its pre-filing scientific meeting with the German Competent Authority responsible for cellular therapies - the Paul Ehrlich Institute (PEI).

During the latter part of 2012, the Company has been making enhancements to the RepliCel™ procedure to improve the quality, characterization, and shelf-life of its autologous hair cell product which has been named RCH-01. RepliCel's scientific team met with experts from the PEI on November 2, 2012 to discuss these important revisions and to receive guidance on its proposed current Good Manufacturing Practice(cGMP)-compliant manufacturing process and product specifications that will be used in the conduct of RepliCel's upcoming Phase II, dose-ranging clinical trial. The PEI experts agreed that the proposed manufacturing process for RCH-01 is acceptable for the conduct of a Phase II study and recommended some additional validation work on the manufacturing process be included in the investigational medicinal product dossier (IMPD) that forms part of the clinical trial application.

The results achieved at this meeting have laid the groundwork for the next pre-filing meeting with PEI experts during which time RepliCel's scientific team will discuss the design and methodology of its Phase II clinical trial to be implemented in Germany. This trial is designed to confirm the efficacy of injections of RCH-01 in over 100 male participants. In addition to augmenting the Company's information on the safety of injections of RCH-01, the trial will also provide insight into the optimal treatment regimen for hair growth. The meeting with the PEI, and subsequent confirmation of the design of the Phase II clinical trial, will be completed prior to the end of 2012.

RepliCel's scientific team anticipates the non-binding recommendations received at these meetings, in advance of submitting the formal clinical trial application, will help ensure that all regulatory requirements are met in order to facilitate a smooth review, approval, and implementation of future clinical research. The Company anticipates initiation of the Phase II study by mid-2013.

"We are pleased with the direction and counsel offered by the experts at the PEI," stated Darrell Panich, RepliCel's VP Clinical Affairs. "Our next step is to reappear before a different panel of experts at the PEI next month to obtain counsel that will assist us in finalizing the clinical design which will allow us to complete our application. We are delighted to be one step closer to the initiation of our Phase II trial."

11-07-2012, 10:08 PM
Don't expect an update from them for probably 8 months to a year, It's clear they went back to the planning stages in order to change the formula.

I do hope they find something though.