Positive Results from RepliCel’s (OTCQB: $REPCF; TSX:
$RP.V) RCS-01 Phase I Skin Trial are the Company’s Most Compelling to Date
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,
BC – April 4, 2017 – (Investorideas.com Newswire) 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.”
Read this release in full
at http://www.investorideas.com/news/2017/biotech/04041REPCF.asp
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.
For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com
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.
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