UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT
TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of March, 2017
Commission File Number 000-50112
RepliCel Life Sciences Inc.
(Translation of registrant’s name
into English)
Suite 900 - 570 Granville Street,
Vancouver, British Columbia V6C 3P1
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F ☒ Form
40-F ☐
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) ☐
Note: Regulation S-T Rule
101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security
holders.
SUBMITTED HEREWITH
99.1 News Release dated
March 28, 2017 - RepliCel's Successful RCT-01 Tendon Repair Clinical Trial Shows Signs of Healing Chronic Tendon Problems
SIGNATURES
Pursuant to the requirements of
the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
RepliCel Life Sciences Inc.
/s/ Lee Buckler
Lee Buckler, President
Date: March 28, 2017
3
Exhibit 99.1
RepliCel's Successful RCT-01 Tendon Repair Clinical Trial
Shows Signs of Healing Chronic Tendon Problems
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.
To view the original version on PR Newswire, visit: http://www.newswire.ca/en/releases/archive/March2017/28/c1626.html
%CIK: 0001205059
For further information: Lee Buckler, CEO and President, Telephone:
604-248-8693 / lee@replicel.com
CO: RepliCel Life Sciences Inc.
CNW 06:00e 28-MAR-17
This regulatory filing also includes additional resources:
ex991.pdf
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