"We believe that this novel therapy has the
potential to rejuvenate skin in a way we've never seen before",
states key opinion leader in dermatology research
DUSSELDORF, Germany,
Aug. 10, 2017 /CNW/ - Following an
interview with Prof. Dr. med Jean Krutmann, one of the world's
leading researchers on skin aging, RepliCel Life Sciences Inc.
(OTCQB: REPCF) (TSXV: RP) (FRA: P6P2) ("RepliCel" or the "Company")
is pleased to provide the following insights regarding the data
from RepliCel's recent clinical study of RCS-01 for aging and
sun-damaged skin.
Q: In your center, a phase 1 trial has been performed to
assess the safety of an autologous cell product against skin
aging. Can you tell us why, in your opinion, the data from
this trial suggests to you that such a cell treatment has the
potential to treat signs of skin aging?
Prof. Dr. med Jean Krutmann: I am personally very
interested in this approach because it represents, to the best of
my knowledge, the first cell-based treatment option for skin aging.
I had the privilege to oversee the conduct of the phase 1 trial of
this product in our Institute. In addition to the results
indicating that the therapy is safe to use in humans, we observed
in the data from this study that several molecular biomarkers of
skin aging significantly improved in areas treated with the cell
therapy, as compared to placebo-treated skin.
Q: What do you see as the advantage of cell treatment,
compared to other modalities?
Prof. Dr. med Jean Krutmann: The novelty of this cell
treatment is that it directly affects and interacts with the
dermis and is capable of modulating gene expression in the treated
skin. For us this means we expect it will likely show long-term
effects on the aesthetic effects of skin aging – in other words,
positively impact the skin wrinkles and appearance.
Q: In addition to safety parameters, expression of several
molecular markers was assessed as well. What was the purpose
of this?
Prof. Dr. med Jean Krutmann: The molecular
markers assessed in this study were all related to skin aging. The
data suggests the cell therapy can affect the marker expression in
a way which indicates that skin aging can be counteracted by being
treated with this product. In other words, we believe the data
indicates the effects of skin aging can potentially be
reversed.
Q: Could you give us your expert opinion about the
results?
Prof. Dr. med Jean Krutmann: As a scientist
specializing in skin aging and having studied a wide variety of
different types of products, I am struck by the efficacy of the
treatment. Although the number of study participants was
limited, we obtained significant results as compared with
placebo-treated skin. For example, we looked for Collagen-1
transcripts in cell-treated versus placebo-treated skin and found a
remarkable, statistically significant up-regulation (increase) of
collagens in the cell-treated skin. This is very remarkable
to see in such a small trial and suggests to me that this product
might be very effective in countering the effects of skin
aging.
Q: What would be in your view the next steps?
Prof. Dr. med Jean Krutmann: The next natural
step is a phase 2 study to directly look at the efficacy of the
cell therapy for the treatment of pre-existing clinical signs of
skin aging. One of the things being considered is
accompanying the clinical study with a research study to provide
further insights into the underlying anti-aging mechanisms. Already
plans are being finalized for both projects. We believe that
this novel therapy has the potential to rejuvenate skin in a way
we've never seen before.
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 cited by Prof. Dr. med Jean Krutmann is a
randomized, double-blind, placebo-controlled, single-centre, phase
I study evaluating RCS-01 for the treatment of aging and
sun-damaged skin. Recently, statistically and clinically
significant positive data was released from the interim analysis of
this phase I study. The data revealed a nearly two-fold increase in
gene expression of collagen-related biomarkers in the skin, after a
single injection of RCS-01. 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. Further details are available at
http://replicel.com/20170404/.
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 400 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, the Dermopharmacy Innovation Award and the
Xu Guang Qi Lecturer Award. He is a visiting and adjunct professor
at the Nagoya City University,
Japan, Case
Western Reserve University, Cleveland, Ohio, University of Alabama, Birmingham, AL, USA, and
Fudan University, Shanghai, China.
He is a member of the National Academy of Science of Germany. He is a clinical consultant to
RepliCel Life Sciences, Inc.
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 potential effects of
RCS-01 on skin aging. 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 show long term aesthetic effects on skin aging; its
ability to counteract skin aging and revise the effects of skin
aging; 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 the RCS-01 therapy is a novel
therapy that has the potential to rejuvenate skin in a way never
seen before; the potential correlation between changes in
biomarkers and clinically important endpoints; that the Company
will conduct a phase 2 study; 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.