As Seen In
August 7, 2014 – Mark Landy from Summer Street Research Partners Comments on RepliCel in August’s issues of The Life Sciences Report
To read the full report click here: Mark Landy on New Growth Ideas for Biotech Investors
The following is an excerpt from The Life Sciences Report, with Mark Landy’s comments on RepliCel:
“RepliCel Life Sciences Inc. is at the forefront of the utilization of stem cells to treat disorders and defects.”
TLSR: Your universe of coverage includes medical technology and regenerative
medicine. Would you talk about some names, please? Do you have a regenerative
medicine story you can share?
ML: While I don’t formally cover RepliCel Life Sciences Inc. (RP:TSX.V;
REPCF:OTCQB), I do find it an interesting and exciting story. I have been doing
diligence on the company to learn more about its technology and opportunities. It
falls into a new category of medicine that is very intriguing to me: regenerative
medicine and gene therapy. RepliCel and another company I follow, Harvard
Apparatus Regenerative Technology Inc. (HART:NASDAQ), are at the forefront of
the utilization of stem cells to treat disorders and defects, which is definitely the
future of medicine.
TLSR: RepliCel has two proposed Phase 2 trials with its RCT-01 (non-bulbar
dermal sheath fibroblasts) cells, which should be initiated before the end of this
year. One trial will be for the Achilles tendinosis indication. I realize that as a Phase
2, this is not designed to be a pivotal trial. But will 82 patients, 41 of whom will
receive RCT-01, be enough to get an indication of efficacy?
ML: To me, the real questions are: What could go wrong and is it safe? My
hypothesis is: Not a whole lot can go wrong and the therapy will be safe, as the
company is using autologous cells. Autologous cells are taken from an individual
and returned to the body. They are a perfect immunological match, and if handled in
a safe and appropriate manner, should not cause the patient any harm. At this
stage, I think what we are all interested in is the safety of RepliCel’s therapy, and I
do not see a lot of risk.
With that said, you are right: The numbers in this study may be too small to determine scientific evidence of efficacy. However, companies like to get some understanding
or signal indicating that there could be efficacy, and they like to learn how to power
larger studies. Also, and more important, in some countries, the pathway to
approval and commercialization for stem cell therapy is being altered so that
companies only need to generate safety data in trials. Then, within a specified
amount of time, they must provide data on efficacy to maintain the therapies on the
market. This is an opportunity that RepliCel can take advantage of, shortening the
cost and time to market in some countries.
TLSR: The other proposed Phase 2 study will be in androgenic alopecia (male
pattern baldness). This study will be with a total of 160 male patients—two
experimental arms, one with 66 single injections and one with 66 repeat injections,
with a 28-patient control arm. What could this trial tell us?
ML: RepliCel could get an indication of efficacy, and could also use this study to
solidify a commercial partner with the financial resources to take the product to
market. This is RepliCel’s strategy: to develop new products and therapies, and
then license the commercial rights to companies with deep pockets and strong
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