Interim trial results lead researchers to
conclude that the injection of RCS-01 is not only very safe, but
also has the potential to reverse effects of aging skin,
representing a natural alternative to existing anti-aging
treatments
VANCOUVER, April 4, 2017 /CNW/ - RepliCel Life Sciences Inc.
(OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company")
is pleased to report statistically and clinically significant
positive data from the interim analysis of its phase I study
evaluating RCS-01 for the treatment of aging and sun-damaged
skin.
The primary objective of this trial was to establish a complete
safety profile for intradermal injections of RCS-01 (RepliCel's
type 1 collagen-expressing, hair follicle-derived fibroblasts
["NBDS cells"]) at six months post-injection. Participants in the
Germany-based study did not report
any serious adverse events at the interim point of the trial.
Researchers also gathered compelling positive proof-of-concept data
indicating the product's potential for skin rejuvenation.
The study was neither powered for, nor was expected to show
statistically significant results of efficacy. However, the nearly
two-fold increase in gene expression of collagen-related biomarkers
in the skin, after a single injection of RCS-01, was so profound
with a single RCS-01 injection, that the results are considered
statistically significant. The study observed the impact of the
injection on ten different biomarkers that, in peer-reviewed
medical literature, are highly correlated with skin aging and
chronically sun-damaged skin. Notably, gene expression markers,
such as tissue inhibitor of metalloproteinases (TIMP), showed
significant changes expected to correlate with increased collagen
fibers. Increased collagen production, and reduced collagen
degradation, is associated with fewer wrinkles and the repair of
sun-damaged skin.
"This type of positive effect on TIMP gene expression, which is
related to protection against collagen degeneration, is rarely
observed. In my experience, after decades of performing these
tests, this is an exceptional finding, particularly for a safety
trial with a small sample size," stated Prof. Dr. med Jean
Krutmann, Scientific Manager of the IUF Leibniz Research Institute
for Environmental Medicine where the study was conducted. "The
promising results demonstrate the potential of RCS-01 to promote
skin rejuvenation. An increase in collagen markers of this nature
would be expected to translate into clinically measurable and
aesthetically visible effects."
Krutmann concluded: "Replication of these results in a larger
trial would confirm our view of the product's potential as a more
natural alternative to Botulinum toxins and fillers that only
temporarily prevent and reverse the signs of
aging."
"This study not only showed an excellent safety profile, but
also provides compelling proof-of-concept that RepliCel's RCS-01
cells are, by nature, very good collagen producers in the skin,"
stated Dr. Rolf Hoffmann, RepliCel's
Chief Medical Officer. "We are highly encouraged by the findings
and eager to demonstrate the correlation between the change in
these biomarkers and clinically important endpoints such as wrinkle
depth, in a larger multi-centre trial studying optimal dose and
treatment frequency."
"As a practicing dermatologist," Hoffmann continued, "the
potential of RCS-01 represents a leap-forward in the way we look at
skin anti-aging, especially for the fine wrinkles in UV-damaged
skin where we have no long-lasting treatment today. Of importance
is the fact that, because RCS-01 is comprised of cells derived from
tissue at the back of the patient's scalp, these cells are not only
very good collagen producers, but also UV- protected and therefore
more functionally active."
"In my opinion," Hoffmann concluded, "this is the first example
of a treatment potentially capable of rejuvenating UV-damaged
skin."
"This is the most compelling data we have announced to date,"
stated RepliCel CEO and President, R. Lee
Buckler. "Longer term, this data is very complementary to
our focus on commercializing a next-generation dermal injector and
its targeted application not only with RCS-01, but also with other
aesthetic products on the market today. We look forward to
discussing these findings and the potential of our products with a
number of aesthetic-focused institutional investors and major
multinational licensing partners who have already expressed
interest in our programs."
About Aging and UV-damaged Skin Markets
Ultra-violet (UV) light exposure from the sun is responsible for
up to 80% of visible facial skin aging. According to statistics
from the American Society for Plastic Surgeons, $2.5 billion was spent on facial aesthetics in
2013 and this is predicted to grow to over $5.4 billion by 2020. Dermal filler procedures
are growing over 15% annually.
About the RCS-01 Study
The clinical trial was a randomized, double-blind,
placebo-controlled, single-centre, phase I safety study of
intradermal injections of RCS-01 in healthy subjects. The primary
endpoint was to assess the local safety profile by recording and
evaluating adverse events reported at the treatment evaluation
sites. Secondary safety measures related to any reporting of
systemic adverse events and assessment of histopathological
abnormalities of the treatment sites. Secondary endpoints also
included evaluating any changes in expression of numerous genetic
markers (using real-time PCR) related to intrinsic skin aging, skin
wrinkling and solar degeneration of skin.
After trial inclusion, all participants provided a biopsy from
the scalp from which RCS-01 was prepared at a central GMP
manufacturing site. Study participants were randomized to one of
two treatment subgroups that received intradermal injections of
either RCS-01 or placebo. Each participant had four treatment
evaluations sites identified on their buttocks, two on each side to
allow for a within-subject comparison of single and triple
injections of RCS-01 with placebo respectively. Participants in the
RCS-01 Subgroup received injections of RCS-01 or placebo or a
'sham' injection (a needle penetration without injection of
liquid). Participants in the Placebo Subgroup were randomized to
receive only injections of placebo or sham injections to compare
the systemic safety profile to the RCS Subgroup.
Baseline evaluations of subjects' overall health and skin
condition at treatment sites on their buttocks were performed
before receipt of injections at Day 0. In addition to injections
delivered at Day 0, the pre-selected treatment evaluation sites
received intradermal injections of RCS-01 or placebo (cryomedium)
or a sham injection four and eight weeks after Day 0 according to a
randomization schedule for a total of three injections per
treatment site.
All participants returned/will return to the clinic for at least
nine visits to monitor safety. Assessment of the local safety
profile was performed by the investigator before each injection
visit, two to four days after injection, and 12 and 26 weeks after
injection. The investigator was asked to examine each treatment
site for the presence or absence of local adverse events and grade
them with respect to relatedness to treatment, severity and
seriousness. Other study assessments included recording of vital
signs at each visit and routine laboratory assessments at
screening, injection visits and at the Week 26 time point. At
the 12-week time point, nine randomly selected participants
provided biopsies from all injection sites for gene expression
analysis of skin markers related to aging. At Week-26 (cut-off date
of the interim analysis), the remaining participants provided
biopsies of all injection sites for histopathological analysis.
All reported pre-defined local adverse events related to
injection or sham were transient and mainly mild in intensity only.
No other related local or systemic adverse events were reported. No
clinically relevant abnormal laboratory results or abnormal vital
signs were reported up to the cut-off date of this interim
analysis. Histopathological assessments of treatment evaluation
site biopsies were all judged to be normal by a blinded
investigator.
About Prof. Dr. med Jean Krutmann
Prof Dr. med Jean
Krutmann is Professor of Dermatology and Environmental Medicine and
Director of the IUF Leibniz Research Institute for Environmental
Medicine at the Heinrich-Heine-University Düsseldorf. He is a
coordinator of the Leibniz Research Alliance "Healthy Aging" (a
strategic alliance of 23 Leibniz institutes). His research is in
the field of derma-toxicology and immune-dermatology with special
emphasis on environmentally-induced skin diseases and skin aging.
Prof. Krutmann is author or co-author of more than 200 papers. He
is the recipient of the International Arnold-Rikli-Award, the
Albert Fleckenstein Award, the
Paul Gerson Unna Award, the
Oscar Gans Award, the C.E.R.I.E.S.
Research Support Award and the Dermopharmacy Innovation Award. He
is a visiting and adjunct professor of dermatology at the
Nagoya City University,
Japan, Case Western Case Western
Reserve University, Cleveland,
Ohio and University of Alabama,
Birmingham, AL, USA. He is a member of the National Academy
of Science of Germany and Xu Guang
Qi Lecturer, Shanghai Institute for Biological Sciences (CAS),
Shanghai, China.
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 three clinical-stage
products: RCT-01 for tendon repair, RCS-01 for skin
rejuvenation and RCH-01 for hair restoration. RCH-01 is 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 is also developing 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 information
Certain statements in this
news release are forward-looking statements, which reflect the
expectations of management regarding the results of the RCS-01
Phase 1 skin trial. Forward-looking statements consist of
statements that are not purely historical, including any statements
regarding beliefs, plans, expectations or intentions regarding the
future. Forward looking statements in this news release include:
statements relating to the anti-aging potential of RCS-01, its
ability to promote skin rejuvenation, and its potential as a more
natural alternative to Botulinum toxins and fillers; the Company's
expectation that significant changes to gene expression markers are
expected to correlate with increased collagen fibers; that
increased collagen production and reduced collagen degradation
should potentially lead to fewer wrinkles and the repair of
sun-damaged skin; that RepliCel's RCS-01 cells are by nature very
good collagen producers in the skin; the potential correlation
between changes in biomarkers and clinically important endpoints;
that the potential of RCS-01 represents a leap-forward in skin
anti-aging; the potential application for other aesthetic products;
and the expected timing of return of trial participants for
analysis and the process to be undertaken in connection with same.
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 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 future approvals for clinical
trials; risks associated with the Company obtaining approval for
its clinical trial in Germany;
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.