RepliCel Releases Positive Results from the Interim Analysis of Data from its First-i

[HARIRI]

RepliCel Releases Positive Results from the Interim Analysis of Data from its First-in-man TS001-2009 Clinical Trial

 

VANCOUVER, BRITISH COLUMBIA--(Marketwire -05/02/12)- RepliCel Life Sciences Inc. (the "Company" or "RepliCel") (REPCF.OB - News) is pleased to report positive results from its interim analysis of six-month post-injection data collected from its first-in-man clinical trial (TS001-2009) designed to test the safety and efficacy of the RepliCel™ technology in men and women with androgenetic alopecia (pattern baldness). The primary protocol objective of the study is to assess the local (at treatment sites) safety profile of injections of autologous dermal sheath cup cells (DSCC) at six months post-injection compared to placebo. Secondary protocol objectives are to assess systemic (overall) safety and efficacy (hair growth at treatment sites) at 6 and 24 months post-injection and local safety at 24 months post-injection. The six-month interim analysis was designed to provide the Company with safety information to support the regulatory filing for a Phase IIb clinical trial.

The Company is delighted to report that the six-month interim analysis results support the continued development of DSCC for the treatment of androgenetic alopecia. "The assessment of the primary endpoint of the TS001-2009 clinical trial shows a favourable local safety profile for injections of autologous hair follicle cells," said Darrell Panich, RepliCel's Vice-President of Clinical Affairs. "We are also encouraged that the early analysis of efficacy endpoints has shown a trend for improvement in hair growth parameters and a statistically significant number of participants showing a treatment response. The results of this first-in-man trial tell us that we are on the right track in developing an effective treatment for people suffering from pattern baldness."

All 19 subjects (10 male and 9 female) completed six-month post injection follow-up visits and the data collected from these visits was used for the interim analysis of the primary and secondary safety and efficacy endpoints for the TS001-2009 study.

In regards to the primary objective of assessing the local safety, the primary investigator monitored the injection sites for signs of bleeding (hematoma), bacterial infection (pyoderma), foreign body reaction or cysts (papules) or other skin reactions like eczema (inflammation), atrophy (shrinking of tissue) and any reports of local sensations such as burning and itching at the injection sites from the treatment-blinded patients. The results show that injections of autologous DSCC were very well-tolerated with only a few mild scalp irritations reported. There were no statistically significant differences in the number of local adverse events (AEs) reported at DSCC injection sites as compared to placebo sites.

"Beyond the initial primary endpoint of safety, the interim analysis of our first-in-man trial also provided the Company an early indication of the efficacy of injections of hair follicle cells prepared using the RepliCel™ procedure," said David Hall, President and CEO of RepliCel. "The early safety data is essential for the continued development of the Investigational Medicinal Product Dossier that will support RepliCel's application to conduct a Phase IIb dosing trial of our technology. This initial look at efficacy at six months shows us that these DSCC injections are having a positive effect on hair growth and support a decision to invest in our next clinical program."

The efficacy of injections of autologous DSCC in the treatment of androgenetic alopecia was assessed through measurements of hair growth for those patients treated according to the protocol (16 patients). (Note that 3 patients were removed from this analysis because their injection products were shipped outside of the temperature range stated in the protocol). Relative to measurements taken prior to injection (baseline), the total hair density (the total number of hairs in a given area per cm2) at sites injected with autologous DSCC increased 6.1%. Vellus hair (small/intermediate sized-hair: approximately 10-40um thick) density and terminal hair (thick hair) density increased by 12.5% and 3.2%, respectively. Cumulative hair thickness per area (an estimate of scalp hair coverage; the sum of thickness of all hair diameters in a given area per cm2) also improved (by 4.3%) at DSCC-injected treatment sites relative to baseline measurements.

The response to treatment was assessed for the entire study population by calculating the number of patients demonstrating a greater than or equal to (greater than =) 5% change from baseline hair measurements. The interim analysis results showed a statistically significant difference (P=0.020) between the number of patients demonstrating a greater than =5% increase in total hair density at sites injected with DSCC relative to sites injected with placebo 6 months post-injection. Where 63% of patients demonstrated a greater than =+5% change from baseline at DSCC-treated sites, only 37% showed such an increase at placebo-treated sites. "The significant response shown at DSCC-treated sites and improved hair growth measures, even at this early 6-month time point, fully support further development of the RepliCel™ technology in a larger Phase IIb clinical trial," said Mr. Panich. "Our upcoming study will explore optimum dosing and treatment regimens to improve treatment with injections of autologous DSCC while adding to our data on the safety of these injections."

Secondary safety endpoints at the six-month post-injection time point included assessment of systemic AEs (those being AEs not at treatment sites) and results from independent raters' assessments of injection sites during the first six months post-injection. A total of 25 systemic adverse events were reported by 12 patients during the first six months after study injections were completed. None of the reported events were considered serious or related to the study treatment. Overall, the results from the independent assessment showed no statistically significant differences between assessments of reactions at DSCC and placebo injection sites.

Further analysis of these findings in relation to other study factors will be taking place over the upcoming weeks. Detailed results from this interim analysis will be presented along with results from histopathological analysis of six-month post-injection site biopsies from four patients at the 16th meeting of the European Hair Research Society in Barcelona, Spain, June 21st-23rd, 2012. All results from this interim analysis will be incorporated into the regulatory filings presently being developed for the initiation of a Phase IIb clinical trial.

About 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 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 ten 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 Hair Loss Solution: Replicel's Potential Solution is Under Development.

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 include that RepliCel™ has the potential to become the world's first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. 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; the effects of government regulation on the Company's business; risks associated with the Company's ability to obtain and protect rights to its 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, 2011 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at U.S. Securities and Exchange Commission (Home Page) and with the British Columbia Securities Commission on SEDAR at Welcome to the SEDAR Web Site / Bienvenue au Site Web SEDAR.

Contact:

 

RepliCel Life Sciences Inc.

Tammey George

Director of Communications

604-248-8696

tg@replicel.com

Hair Loss Solution: Replicel's Potential Solution is Under Development

[BadBeat]

Is it just me or are the initial results just mediocre? It just seems that the growth that they achieved is probably the same as Rogaine or Propecia would give you. I'm curious as to what others think about this....

[mahhong]

I think you'll find that is the sort of results they are aiming for to be honest.

 

There has become a misconception that all these current medical trials are researching "the cure". Replicel would see results on a par with finasteride as positive; it would essentially be propecia minus the lifetime commitment, cost and potential side effects (though no doubt may involve its own set of side effects or specific issues).

 

That's obviously disappointing but this is how medicine and medical research works I guess. We're just not going to go from 0-100mph straight away. These techniques are in their infancy and the first stage is really just to make them as effective as their competitors in the marketplace. If Replicel can offer an alternative to finasteride, that would be deemed worthy of a place in the market. To us that might seem disappointing, but to investors it's proof the product can compete.

 

That's why we need to lower our expectations somewhat with Replicel and Histogen and all these other "on the horizon" medical ideas. I have no doubt in the next 10 years some of them will become new products in the fight against hairloss, but they'll just be another string in the bow. This is what doctors mean when they tell you not to refuse hair transplantation and current medical treatment in the hope of a future magic bullet. It isn't going to work like that; evolution, not revolution unfortunately.

[bonkerstonker]

Waste of time waiting for stuff like this there's always something just round the corner that never happens hair cloning was due to be in use by 2012 when intercytex started testing on humans in 2006. I very nearly bought shares in them i'm glad i didn't.

[orlhair1]

Waste of time waiting for stuff like this there's always something just round the corner that never happens hair cloning was due to be in use by 2012 when intercytex started testing on humans in 2006. I very nearly bought shares in them i'm glad i didn't.

 

Agree......all along, Replicel's standard for success was a very low level of growth. I hate to be a skeptic, but with this kind of stuff, I will believe it when I see it and I might not live long enough for that

[aaron1234]

OMG! If RepliCel failz y'all I'm gonna shoot myself! :eek:

 

Or... I'll just get another hair transplant.

[JustOne]

There are companys all over the world trying to cure balding .. companys we have never even heard of . Companys with bald employees trying to find a solution as if their life depended on it...as for replicel . lol . they talked a big game .. all show .. no go . . I realize its in its infancy but they do have a long way to go before they get anything worth while, its time they crack the whip.

So don't show your face around here until you got something worth my time! .... (maniacal laugh)

 

Peace and love to all my balding brothers and sisters , maybe if we rub our bald heads together our hair will grow back.

[bjk1903]

Yes this may not be ground breaking results but you all have to remember that this is just the beginning. Im sure they are looking for ways to improve the result. And even if they don't and this is the max they can get, it is still good for people who are just starting hair loss. The results mean that it stops further hair loss and can even get a little bit of growth. If you are beginning hairloss and just get the Replicell treatment and combine that with a hair transplant, I think you'll be just dandy. Lets wait and see

[bonkerstonker]

If this ever did work It would be ideal to give our sons when they're 16 but no good for us as a life changer I'm sticking to the knife it grows hair every time.

[aaron1234]

I'm sticking to the knife it grows hair every time.

 

Ditto. :cool:

[ShiningDome]

Looks like investors are not happy with the Interim Analysis.