Five-year safety data firmly establishes
product safety and confirms ongoing
clinical and product development strategy
VANCOUVER, March 14, 2017 /CNW/ - RepliCel Life Sciences
Inc. (OTCQB:REPCF) (TSXV:RP) (FRA:P6P2) ("RepliCel" or the
"Company"), a clinical stage regenerative medicine company
developing unique biologic products for pattern baldness and
thinning hair, aging and sun-damaged skin, and chronic tendon
degeneration, today announced the successful completion of its
first-in-human clinical study of the Company's autologous cell
therapy for the treatment of androgenetic alopecia (pattern
baldness).
The Company reports the trial succesfully met its endpoints and
sets the stage for next steps in the ongoing research and
development of its product, RCH-01, for the treatment of male and
female androgenetic alopecia. "As we march toward commercialization
of this product based on this first-in-human data, our aim is to
revolutionize the way we prevent, treat, and even reverse hair
loss," stated RepliCel President and CEO, R. Lee Buckler.
Safety
The five-year trial data set has confirmed the
complete safety profile of a high-dose of dermal sheath cup cells
(DSCC) for patients with pattern baldness due to androgenetic
alopecia.
These DSCC form the basis for the Company's RCH-01 product. The
long-term safety of DSCC injections was demonstrated through
multiple physician, patient and independent measures of local and
systemic tolerance including evaluation of adverse events with
respect to causality, incidence, severity and seriousness. No
serious adverse events were reported over the entire 60.5-month
follow-up period of the trial. Local injection tolerance was
confirmed with only a few minor scalp irritations reported around
injection sites that resolved quickly soon after injection.
Furthermore, histopathological evaluation of injection site
biopsies taken six, 12, and 24 months after injection did not
reveal any pathology that was suggestive of tumour, granuloma or
foreign body formation. An analysis of injection site biopsies
taken 60.5 months after injection is currently ongoing with results
expected in the next few weeks. Long-term systemic safety of RCH-01
was also confirmed as none of the systemic adverse events reported
during the extended safety evaluation were related to
treatment.
Indications of Potential Efficacy
The trial was
designed to gather data related to the product's potential efficacy
through 24 months post-injection, but was not designed for
statistical significance related to any efficacy endpoints. The
efficacy data collected from all 19 patients, while not
statistically significant, provides useful and potentially exciting
insights into the product's potential for the treatment of those
with androgenetic alopecia.
"We have a much greater understanding and opportunity for
further insights from the hair density responses recorded in this
first-in-human trial," stated RepliCel President and CEO,
R. Lee Buckler. "This data will
feedback into our R&D programs and help us develop the best
possible product and treatment protocol for men and women suffering
from androgenetic alopecia."
The seven top-tier responders in the trial saw >10% increase
in hair density at six months post-injection (see May 17, 2012 announcement). At 24 months, the
average hair density increase for these same seven participants was
8.3% over baseline, and three of these seven trial participants
maintained a >10% increase in density over baseline. The largest
increase in hair density over baseline observed in this group was a
21% increase at 24 months.
The top 10 participants reported at least a 5% or greater
increase in hair density at six months post-injection with an
average increase of 11.8% (as reported in the May 17, 2012 announcement). This group
demonstrated a sustained response at 24 months which averaged a
4.2% increase over baseline hair density. While there was a
high degree of variability in hair density between individual
participants at 24 months post-injection compared to baseline, an
overall stabilization of hair loss was observed among all the
patients treated per protocol.
Management Commentary
"The purpose of collecting
efficacy data in these early-stage trials," stated RepliCel's
Clinical Consultant, Darrell Panich, "is for our clinical team
and management to obtain data that can be used to inform basic
decisions about further development, provide provocative insights
into the product's potential, and ¾ perhaps most importantly
¾ provide useful feedback which we can use to drive decisions about
process and product development, ongoing research, and future
clinical trial parameters."
"We are very pleased with the unquestionable safety profile of
RCH-01," stated RepliCel's co-founder and Chief Medical Officer,
Dr. Rolf Hoffmann. "Five-year safety
follow-up is rare for cell therapy products and demonstrates our
commitment to the highest quality of clinical research.
Furthermore, the efficacy signals we see validate the research and
development strategy we have had in place since we saw the
six-month post-injection data in 2012."
Hoffmann continued: "Over the past 36 months, we have invested a
great deal in both basic research and manufacturing optimization
which we believe will be critical to minimizing batch-to-batch
variability and further improving efficacy. We have invested in
process and product development initiatives including a modified
tissue culture technique, improved culture media with addition of
12 new ingredients, introduction of a cell activity promoting step,
and cryopreservation storage to improve cell stability and
viability. We believe these programs have already resulted in a
significantly more robust and better-defined product than the one
used in this trial by many measures and look forward to translating
our continued R&D into next-phase clinical trials in due
course."
"This trial involved the injection of a very high dose of DSCC
in order to identify any potential toxicity ceiling in accordance
with the primary safety objectives of the trial. The efficacy data
we saw in this trial, together with recent animal research data,
suggests that long-term survival of injected cells improves both
with smaller dose size and with several sessions of injections
spaced-out over a set time course to cumulatively increase injected
cell numbers," stated RepliCel's co-founder and Chief Scientific
Officer, Dr. Kevin McElwee. "We
expect cell number and long-term cell survival to be correlative
with hair density efficacy. Next-phase trials will be
designed to test repeated injection sessions with smaller cell
doses than were used in this study."
"Furthermore," continued McElwee, "with this 24-month
post-injection data, and the availability of patient biopsy
material and DSCC, we are now able to commence gene expression
analysis with a goal of identifying the differences between
products which result in superior responses and those that produce
less-than-optimal responses. Ultimately, the goal here is to
correlate and optimize cell dose and use repeat treatment sessions
to achieve peak efficacy in terms of increased hair density."
"In summary," stated RepliCel's President and CEO, R. Lee Buckler, "we are very pleased with the
results of this first-in-human study and are excited to move this
product forward into the next phases of development."
Buckler concluded: "The analysis of data collected from this
study, and the direction it gives our research and development
programs, will support further optimization of the RCH-01 treatment
to be evaluated in future phase II clinical trials. This data,
combined with results expected next year from the Shiseido-funded
study ongoing in Japan, will
support future negotiations with regulators and licensees as we
march toward RCH-01 commercialization. Additionally, we are
confident that using RepliCel's RCI-02 injection device (currently
under development) in future trials will better control the dose,
distribution, and depth of injections to the scalp of study
participants. We expect this to further positively impact the
product's efficacy and the uniformity of response."
About the RCH-01 Clinical Trial (2011 - 2017)
The TS001-2009 first-in-human clinical trial was designed to
test the safety and efficacy of dermal sheath cup cells (DSCC are
the basis for the Company's current RCH-01 product) in men and
women with androgenetic alopecia. The primary protocol
objective of the study was to assess the local (at treatment sites)
safety profile of injections. Secondary protocol objectives
were to assess systemic (whole-body) safety and local efficacy
(hair growth at treatment sites). A total of 19 subjects (10 male
and nine female) were recruited for the trial and all of them
completed 24-month post injection follow-up visits. Seventeen of
those patients went on to complete a full five years of extended
saftey evaluations to provide information on the long-term safety
of DSCC injections. For further details about the trial design,
endpoints, etc see
https://www.clinicaltrials.gov/ct2/show/NCT01286649.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on
developing autologous cell therapies that address conditions caused
by a deficit of healthy cells required for normal tissue healing
and function. The Company's product pipeline is comprised of two
recently completed clinical trials (RCT-01 for tendon repair and
RCS-01 for skin rejuvenation), as well as, its RCH-01 hair
restoration product under exclusive license by Shiseido Company for
certain Asian countries. All product candidates are based on
RepliCel's innovative technology, utilizing cell populations
isolated from a patient's healthy hair follicles. RepliCel has also
developed a proprietary injection device (RCI-02) optimized for the
administration of its products and licensable for use with other
dermatology applications. Please visit http://replicel.com/
for additional information.
Forward-Looking Statements
This press release contains forward-looking statements and
information that involve various risks and uncertainties regarding
future events, including, but not limited to, statements regarding:
(i) that the RCH-01 product will move towards or be commercialized;
(ii) that the RCH-01 product will revolutionize the way that hair
loss is prevented, treated, and reversed; (iii) that clinical data
from a study being conducted in Japan, financed by Shiseido, is expected in
2018; (iv) the Company's RCI-02 injection device (currently under
development) will better control the dose, distribution, and depth
of injections to the scalp of study participants and this will
positively impact RCH-01's efficacy and the uniformity of
response.
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 statements, including: the risk that the
Company will not obtain CE mark clearance or other necessary
regulatory approvals for its injection device; the risk that there
will be delays enrolling clinical trial participants; the risk that
the Company will receive negative results from the Company's
clinical trials; the effects of government regulation on the
Company's business; risks associated with Shiseido obtaining
approval for its clinical trial; risks associated with the Company
obtaining all necessary regulatory approvals for its various
programs in Canada, the
USA and Germany; risks associated with the Company's
ability to obtain and protect rights to its intellectual property;
risks and uncertainties in connection with the outstanding issues
alleged by Shiseido in connection with the License and
Co-development Agreement; 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,
2015 and other periodic reports filed from time-to-time with
the Securities and Exchange Commission on Edgar at www.sec.gov
and with the British Columbia Securities Commission on SEDAR
at www.sedar.com.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
SOURCE RepliCel Life Sciences Inc.