RepliCel Life Sciences Inc. reports that further analysis of results from its successful first-in-man clinical trial revealed substantial hair growth including seven participants with growth in excess of 10%, including 17.2%, 19.2% and 19.6%. Furthermore, there were no negative health effects.
"The RepliCel TS001-2009 trial was a first-in-man trial with a primary endpoint of safety and this was confirmed emphatically," stated Dr. Rolf Hoffmann, Chief Medical Officer at RepliCel. "Even though the size of the trial was only powered for safety measures, secondary endpoints were included in interim analysis to give us an early look at efficacy to allow us to better drive the design of the next steps of the clinical development of the RepliCel(TM) procedure," Dr. Hoffmann concluded.
Darrell Panich, Vice-President of Clinical Affairs at RepliCel said, "While the interim analysis results show us that significantly more subjects (63%) had an increase in hair density of greater than 5% (vs. control) at six months post injection, some subjects had not yet shown an increase at this time point. Participants demonstrated changes from baseline, as much as 19.6%, while others showed decreases of as much as 6.2%. The overall average, as previously reported, was 6.2%." Mr. Panich went on to say, "A negative measurement from baseline at six months is not unexpected as many hair fibres in the area of injection typically fall out from trauma; not unlike hair transplant surgery. Further analysis of the data we collected from our small, first-in-man trial will help us characterize the many factors that determine an individual's response to treatment with injected autologous Dermal Sheath Cup Cells (DSCC) which will lead to an improved treatment regimen."
RepliCel is currently performing an in-depth analysis of the interim data collected during the TS001-2009 clinical trial to identify factors that may impact the efficacy DSCC. The extent of subject response will be reviewed in relation to subject-factors (age, gender, health status, etc.), cell culture factors (duration of cell culture, cell morphology, cell protein markers, gene expression, etc.), and environmental factors (duration between biopsy and culture preparation, shipment durations/temperatures, etc.). "By cross-referencing the subject-response data collected by the primary investigator against other measured variables and against results from histopathological analysis of biopsies collected from treatment zones, we will develop an improved understanding of the factors that impact the efficacy of our technology in humans and therefore the protocol for treatment going forward," said Kevin McElwee, PhD, Chief Scientific Officer of RepliCel. "The development of this technology is an iterative process beginning with our first-in-man trial. The next research steps are driven off the back of the data points that have been collected and will enable development of the next treatment protocol," Dr. McElwee commented further.
RepliCel's next (Phase IIb) trial is designed to be a dose-finding study which will assess the number of characterized cells and the appropriate treatment pattern necessary to promote optimal hair growth. Subject to regulatory approval, the Company is planning a 12-24 month clinical trial that will include multiple subject cohorts studying different doses of DSCC. Each subject will be given several different injections, while some cohorts will receive additional injections at subsequent time points. The Company will also review its standard operating procedures (SOPs) of cell biopsy, cell isolation, cell culture media, cell carrier, and injection media to fine-tune those processes in advance of a regulatory submission for a Phase IIb dosing trial.
Subjects in RepliCel's Phase I/IIa clinical trial 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 Company's first-in-man trial has accomplished the regulatory and corporate goal of providing the required safety data, as well as an early proof of principle in humans of response to treatment," stated David Hall, CEO of RepliCel. "Further analysis of our data and iteration of SOPs will together define the protocols for our next stage of development designed to increase both response and efficacy. We now have the basis for the development of our Investigational Medical Product Dossier and to initiate direct meetings with the appropriate regulatory bodies. We are excited by the results and the opportunity they provide to advance our autologous DSCC therapy towards a successful treatment for pattern baldness in men and women," concluded Mr. Hall.