RepliCel Life Sciences Joins MedCision’s ThawSTAR® Early Adopter Program
16 8월 2017 - 8:30PM
Business Wire
Regenerative Medicine Company to Adopt
ThawSTAR® Cell Thawing Systems to De-Risk Cell Therapy
Clinical Trial
MedCision, LLC, the world leader in next-generation automated
cell thawing for advanced therapies, and RepliCel Life Sciences,
Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel”),
a regenerative medicine company, today announced that RepliCel has
joined MedCision’s ThawSTAR® Early Adopter Program, a novel program
that helps companies and investigators de-risk thawing of cell
therapies in early stage clinical trials through to
commercialization and point-of-care. Each participant will receive
a ThawSTAR® System on loan that is custom engineered for their
unique cell therapy product.
RepliCel Life Sciences intends to adopt ThawSTAR® AT2 Automated Cell Thawing Systems, for thawing
of Aseptic Technologies 2.0ml AT-Closed Vials®, into their Phase 2
clinical trial for skin rejuvenation (RCS-01). This NBDS Fibroblast
therapy trial will address skin damage caused by aging or UV
rays.
The ThawSTAR® System helps eliminate variability prior to
therapy administration to a patient by critical control of vial
thawing. The first-of-its-kind, digitally enabled, automated
instrument was specifically designed to de-risk thawing of live
cell therapeutics.
RepliCel’s President and CEO, R. Lee Buckler, commented: “As we
get ready to launch our Phase 2 study for RCS-01 injections, we
have greater confidence knowing we are using a programmable cell
thawing technology. The ThawSTAR technology has been validated in
many studies, and I believe that our trial and the industry on a
whole will benefit greatly from replacing unstandardized, manual
thawing methods with an automated cell thawing system.”
“Clinical trials involving live and dividing cells are far more
complex and risky for sponsors and investigators than other types
of therapies, and the success or failure of a trial could come down
to results being adversely affected by drug handling,” said Rolf
Ehrhardt, MD, PhD, Chief Executive Officer of MedCision. “All of
the execution, effort, and money that goes into production of the
therapy can be undone with errors in the last step prior to
administration: thawing. Our ThawSTAR System is designed to
avoid these problems. We are delighted to support RepliCel Life
Sciences, an innovative regenerative medicine company, in their
trials.”
For more information about the program, visit
https://www.medcision.com/resources/thawstar-clinical-early-adopter-program/.
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.
About MedCision
MedCision is the world leader in next-generation automated cell
thawing for advanced therapies. The company develops and
commercializes technologies that automate and standardize the
clinical handling and processing of biologics. MedCision's
digitally enabled ThawSTAR® Automated Cell Thawing Systems are
designed to replace uncontrolled and highly variable manual
methods, de-risking the therapeutic cell thawing process and
optimizing cell efficacy. An industry first, ThawSTAR systems
optimize cell thawing using a customizable algorithm for each
unique cell therapy product and protocol. These systems, combined
with MedCision’s ultra-low temperature cold storage and transport
solutions, advance near-patient drug management by providing
controlled and scalable processing of temperature-sensitive
biotherapeutic products. For more information please visit
www.medcision.com or www.medcision.com/blog/.
Forward-looking Statements
Certain statements in this news release are forward-looking
statements, which reflect the expectations of management regarding
the results of the UBC project outlined in this release.
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 statements that (i) data from this project is
expected to take RepliCel’s products to next level of potential
commercial viability; (ii) the gene and protein expression map will
improve key components of the manufacturing, regulatory, and
clinical profile of RepliCel’s cell therapy products; and (iii) the
results will improve our product manufacturing, clinical outcomes,
and assays critical to regulatory approval and commercialization.
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, 2016 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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version on businesswire.com: http://www.businesswire.com/news/home/20170816005360/en/
Media Contact for MedCision:Nicole Litchfield,
415-793-6468press@medcision.comorBusiness Development Contact for
MedCision:Samuel Kent, 415-342-4814busdev@medcision.com
RepliCel Life Sciences (TSXV:RP)
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RepliCel Life Sciences (TSXV:RP)
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