BELLEVILLE, ON,
July 18, 2014 /PRNewswire/ - Bioniche
Life Sciences Inc. (TSX: BNC) today provided a key regulatory
update on its flagship Phase 3 program, Mycobacterial Cell
Wall-Nucleic Acid Complex (MCNA) sterile suspension for the
treatment of patients with Bacillus Calmette-Guérin (BCG)
refractory high grade non-muscle invasive bladder cancer.
MCNA U.S. Regulatory Update
Following several months of active dialogue with
the U.S. Food and Drug Administration (FDA), concerning the most
appropriate regulatory pathway for MCNA approval in the United States, Bioniche has received
written guidance. This guidance provides regulatory clarity and
permits the submission of an MCNA Biological License Application
(BLA) for U.S. marketing approval review based on Bioniche's
existing clinical trial data set.
In accordance with this feedback and in
preparation for a timely and efficient submission of its MCNA BLA,
Bioniche has engaged a top-tier global regulatory consulting firm
that will help in the review and final preparation of the BLA.
Bioniche will provide guidance on the anticipated timelines of this
BLA submission following the completion of a full assessment of the
regulatory tasks required to complete all BLA requirements.
Dr. Michael
Berendt, CEO of Bioniche Life Sciences Inc., commented:
"This is the beginning of a new and significant transformative path
for BCG refractory bladder cancer patients as well as for Bioniche
and its shareholders. We are excited to have the opportunity to
file a BLA for MCNA based upon our existing regulatory dossier and
are determined and committed to making MCNA available to high grade
non-muscle invasive bladder cancer patients who have failed BCG
treatment and who are in dire need of treatment options beyond
cystectomy." He continued: "This significant achievement is a
testament to the hard work, determination and dedication of the
committed team of people, including present and former staff,
medical professionals and others who have contributed to advancing
MCNA to this point".
Focus on Increasing Awareness of MCNA and
Partnering Discussions
With regulatory clarity in hand, Bioniche is now
in a position to advance discussions with potential partners who
have demonstrated a commercial interest in MCNA for both the U.S.
and other world-wide markets.
In parallel and in further support of its MCNA
partnering discussions and so as to increase MCNA visibility within
the broader urology community, Bioniche and its collaborators have
prepared a clinical manuscript, describing MCNA Phase 3 results and
post-study analyses, that is being submitted to a top-tier urology
journal.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a clinical stage
Canadian biopharmaceutical company focused on the discovery,
development, manufacturing, and marketing of proprietary and
innovative therapies for the global human health market. The
Company's primary goal is to develop and commercialize products
that advance human health and increase shareholder value. For more
information, please visit www.Bioniche.com.
Except for historical information, this news
release may contain forward-looking statements that reflect the
Company's current expectation regarding future events. These
forward-looking statements involve risk and uncertainties, which
may cause, but are not limited to, changing market conditions, the
successful and timely completion of clinical studies, the
establishment of corporate alliances, the impact of competitive
products and pricing, new product development, uncertainties
related to the regulatory approval process, and other risks
detailed from time to time in the Company's ongoing quarterly and
annual reporting.
SOURCE Bioniche Life Sciences Inc.