First-in-human clinical study meets primary
endpoint demonstrating product safety and clinical potential for
tendon regeneration and healing
VANCOUVER, March 28, 2017 /CNW/ -RepliCel Life Sciences Inc.
(OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company")
is pleased to report compelling safety and clinical data from its
phase 1/2 tendon repair study investigating the use of RepliCel's
type 1 collagen-expressing, hair follicle-derived fibroblasts
(RCT-01) as a treatment for Achilles tendinosis.
The clinical trial met its goal of establishing a complete
safety profile at 6 months and showed no serious adverse events
related to the study treatment or injection procedure.
Additionally, each of the treated participants, all of whom
suffered chronic tendon pain and loss of function over an extended
period of time with no recovery from standard treatments, showed
numerous clinically important improvements by various measures
including tendon composition, blood supply, physical function and
pain sensation.
"Chronic tendinosis is a state of tendon degeneration that is
very difficult to reverse, as evidenced by the many therapies used
to try and treat it," stated Dr. Ross
Davidson, an orthopedic surgeon, former clinical professor
at the Department of Orthopaedics at the University of British Columbia, and past head
physician and orthopaedic consultant for the Vancouver Canucks (of
the National Hockey League (NHL).
"This study shows exciting clinical improvements in patients
with clinically diagnosed chronic Achilles tendinosis who were
unresponsive to standard treatments, and who had suffered for many
months (in some cases, years) with frequent pain and loss of
function. Not only did the study show several clinically
important improvements in pain and function scores, but several
ultrasound measures clearly demonstrate a marked improvement in
tendon structure; something rarely seen in patients with this
condition," said Davidson.
"With further clinical studies, this new technology could
represent a cutting-edge advancement in kick-starting a healing
process that results in tendon regeneration. For the first time, we
may have a treatment that shows signs of reversing the underlying
problem, versus just treating the symptoms. This could be a
game-changer in sports medicine," Dr. Davidson concluded.
The most clinically material improvements observed from the
study are summarized as follows:
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VISA-A
Scale of Achilles Tendon Injury Severity
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Participants treated
with RCT-01 in the per protocol population who completed the VISA-A
evaluation 6 months after receipt of injections showed clinically
relevant signals of healing including an overall 15.3% improvement
in total score compared to baseline. Two patients showed select
measures of near-complete recovery in function (by VISA-A
scoring).
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VAS Scale of Pain
Severity
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Four out of five
participants treated with RCT-01 who completed questionnaires 6
months after injection showed clinically relevant signals of
improvement in pain on loading (running/jumping) based on VAS
score. Average improvement in VAS score for the four participants
was 62.9% over baseline VAS score.
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Three out of five
participants treated with RCT-01 who completed questionnaires 6
months after injection showed improvement in pain on palpation
based on VAS score. Average improvement in VAS score for the three
participants was 55.2% over baseline VAS score.
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Two patients showed
select measures of near-complete elimination of pain (by VAS
scoring).
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"This trial was to show the safety of injection of hair
follicle-derived non-bulbar dermal sheath cells (NBDS),"
stated RepliCel's Chief Medical Officer, Dr. Rolf Hoffman, "as well as to repeat the landmark
trials of our collaborators who injected skin-derived fibroblasts
together with PRP (platelet-rich plasma) in different
tendinopathies. We believe the cause of healing (mechanism of
action) in those studies was the cellular collagen production and
not the PRP which, in our view, has little clinical or commercial
potential as a therapeutic product or treatment for tendon
repair."
"I am very pleased that in this trial we see some early signals
of regenerative healing in some patients and because of its similar
pathogenesis, there is every reason to believe the ability to heal
Achilles tendons will extend to numerous applications including
repairing the patellar tendon of the knee (jumper's knee), both
tendons of elbow (tennis elbow, golfer's elbow), and the rotator
cuff," observed Dr. Hoffmann. "Furthermore," he concluded, "when we
have established that our cell therapy heals chronic tendon injury,
it may then be used by physicians for more acute injury with the
goal of an approved label for these additional treatments in the
future."
"This is a major step forward in the Company's development of a
series of products which leverage the exciting collagen-producing
capacity of these cells," stated RepliCel CEO, Lee Buckler. "Our management and clinical team
are very excited about the data from this trial and the potential
for further development and clinical testing of this product to
treat patients without good options for the tendon degeneration,
pain and loss of function they are experiencing."
Buckler concluded: "We have captured the medical and investment
communities' attention and see the results of this much
anticipated, proof-of-concept clinical study as an opportunity to
advance therapies for patients and incrementally add value for
shareholders in the months ahead."
About Achilles Tendinopathy
Achilles tendinopathy is a
condition that causes pain, swelling and stiffness of the Achilles
tendon that joins your heel bone to your calf muscles. It is
thought to be caused by repeated tiny injuries to the Achilles
tendon. These may occur for a number of reasons, including overuse
of the tendon; for example, in runners. Treatments range from
physiotherapy, to anti-inflammatory medications, to surgery. For
many people, symptoms of Achilles tendon injury usually clear
within three to six months of starting treatment. However, for some
people the injury does not respond to treatment and progresses to
chronic tendinosis. There is an estimated incidence rate of 656,211
new cases of mid-portion Achilles tendinopathy each year in
North America alone, according to
statistics published in the British Journal of Sports
Medicine.
About the RCT-01 Tendon Repair Study
The study was
designed to demonstrate the safety of a single injection of
RepliCel's RCT-01 into the Achilles tendon. While the study was not
designed to be statistically significant for efficacy, multiple
measures of efficacy were incorporated to give insights into the
product's potential and to assist in guiding future development
decisions. Measures of whether the product may be working included
testing and scoring patient pain in various settings, evaluating
overall function, blood flow changes in the tendon, and changes in
the overall density and composition of the tendon as measured by
ultrasound imaging. For further trial details see:
https://www.clinicaltrials.gov/ct2/show/NCT02330146.
The first-in-human study involved patients clinically diagnosed
with chronic Achilles tendinosis. The primary purpose of this
single-centre, phase 1/2 randomized (3:1), double blind,
placebo-controlled trial was to assess the safety profile of RCT-01
injections, as compared to placebo injections. The study also
measured the potential efficacy and impact injections had on tendon
structure and function and the symptoms of Achilles tendinosis. The
study was led by principal investigator Dr. Rob Lloyd-Smith, MDCM of the University of British Columbia (UBC) and was
conducted at the UBC Sports Medicine Clinic in Vancouver, BC, Canada. Data from such a trial, not designed
for statistical significance, often signals clinically
significance, which is extremely informative for future product
development and clinical trial design. The goal of the study
was to establish sufficient evidence of safety to allow the Company
to proceed with well-powered phase 2 studies investigating optimal
dosing, treatment frequency, effect duration, etc.
As was expected with injecting 1.5mL into the Achilles tendon,
all study participants who received injections (less one
RCT-01-injected participant) reported at least one adverse event
related to treatment regardless of treatment administered (RCT-01
or placebo). The adverse events were either soreness at the
injection site or the observation of a partial thickness tear in
the tendon post-injection. Most reports of soreness resolved
shortly after receiving injections.
About Tendon Treatment Clinical Efficacy Measurements
VISA-A
The VISA-A scale aims to evaluate the clinical
severity for patients with chronic Achilles tendinopathy. It is a
questionnaire which evaluates symptoms and their effect on physical
activity. It can be used to compare different populations with
chronic Achilles tendinopathy and facilitate comparisons between
studies. It can be used to determine the patient's clinical
severity. The VISA-A represents a clinically validated, reliable
and disease-specific questionnaire to measure the condition of the
Achilles tendon, but it is not a diagnostic tool. The final version
of the questionnaire was named the Victorian Institute of Sport
Assessment-Achilles Questionnaire.
VAS
A Visual Analogue Scale (VAS) is often used in
epidemiologic and clinical research to measure the intensity or
frequency of various symptoms. It is an instrument that measures a
characteristic or attitude that is believed to range across a
continuum of values and cannot easily be directly measured. For
example, the amount of pain that a patient feels ranges across a
continuum from none to an extreme amount of pain. From the
patient's perspective, this spectrum appears on a continuum, in
that their pain does not take discrete jumps, as a categorization
of none, mild, moderate and severe would suggest. It was to capture
this idea of an underlying continuum that the VAS was devised.
About Dr. Ross
Davidson
Dr. Davidson is the former Director,
Post Graduate Programmes in Sports Medicine at the University of
Auckland, and a member of the New
Zealand Orthopaedic Association and the Canadian Orthopaedic
Association. He is the past president of the National Hockey League
Physicians Society, past head physician and orthopaedic consultant
for the Vancouver Canucks Hockey Club (NHL), past orthopaedic
consultant to the Vancouver Grizzlies Basketball Team (NBA), past
orthopaedic consultant to Allan McGavin Sports Medicine Centre, and
past orthopaedic consultant to the Canadian Football League Players
Association. Dr. Davidson held the position of clinical professor,
department of orthopaedics at the University
of British Columbia until 2000.
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 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 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 information
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 RCT-01 has the ability to heal Achilles tendons,
(ii) that RCT-01 will extend to numerous applications including
repairing the patellar tendon of the knee (jumper's knee), both
tendons of elbow (tennis elbow, golfer's elbow), and the rotator
cuff, (ii) that the results of this clinical study will act as an
opportunity to advance therapies for patients and incrementally add
value for shareholders over the months ahead.
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.