Critical Outcome Technologies Applies for Orphan Drug Designation for COTI-2 Treatment of Ovarian Cancer
04 Abril 2014 - 7:00AM
Marketwired
Critical Outcome Technologies Applies for Orphan Drug Designation
for COTI-2 Treatment of Ovarian Cancer
Orphan Drug Designation Could Serve Unmet Medical Need and
Provide Significant Financial Benefits
LONDON, ONTARIO--(Marketwired - Apr 4, 2014) - Critical Outcome
Technologies Inc. ("COTI" or the "Company") (TSX-VENTURE:COT), the
bioinformatics and accelerated drug discovery company, announced
today it has submitted an Orphan Drug Application to the U.S. Food
and Drug Administration (FDA) for its lead cancer drug candidate,
COTI-2, for the treatment of ovarian cancer.
"We believe that COTI-2, with its p53 dependent mechanism of
action, represents a significant therapeutic advantage over
treatments currently available for ovarian and other gynecological
cancers," said Dr. Wayne Danter, President and CEO. "The fact that
more than 95% of ovarian cancers have a p53 gene mutation, combined
with the extent of the unmet medical need in ovarian cancer
patients, makes a treatment for this indication one of our top
priorities. If COTI-2 is granted Orphan Drug status, the financial
benefits in the future could be substantial and COTI-2 would be
directed down a unique development pathway within the FDA,
including the possibility of an expedited regulatory process and
the potential for fewer patients to be required in clinical
trials."
The Orphan Drug Designation may qualify the Company for several
benefits under the U.S. Orphan Drug Act of 1983 (ODA), as amended.
These benefits may include a seven-year period of orphan drug
exclusivity upon product approval, fee reductions, assistance in
study design from the FDA, potential for expedited drug development
and eligibility for drug grants.
About Orphan Drug
Designation
Under the Orphan Drug Act, the FDA may grant the Orphan Drug
Designation to facilitate drug development for drugs that target
conditions affecting fewer than 200,000 patients in the United
States each year, while providing a significant therapeutic
advantage over existing therapies. The first new drug application
to receive FDA approval for a particular active ingredient to treat
a particular disease with FDA orphan drug designation is entitled
to a seven-year exclusive marketing period in the U.S. for that
product, for that indication.
About Critical Outcome
Technologies Inc.
COTI is a leading-edge technology company specializing in
accelerating the discovery and development of small molecules -
dramatically reducing the time and cost to bring new drugs to
market. COTI's proprietary artificial intelligence system,
CHEMSAS®, utilizes a series of predictive computer models to
identify compounds with a high probability of being successfully
developed from disease specific drug discovery through chemical
optimization and preclinical testing. These compounds are targeted
for a variety of diseases, particularly those for which current
treatments are either lacking or ineffective.
For more information, visit www.criticaloutcome.com.
Follow @CriticalOutcome on Twitter at
http://twitter.com/CriticalOutcome.
Notice to
Readers
Information contained in this press release may contain certain
statements, which constitute "forward- looking statements" within
the meaning of the Securities Act (Ontario) and applicable
securities laws. For example, the statement "… the financial
benefits in the future could be substantial and COTI-2 would be
directed down a unique development pathway within the FDA,
including the possibility of an expedited regulatory process and
the potential for fewer patients to be required in clinical trials"
and "… may qualify the Company for several benefits under the U.S.
Orphan Drug Act of 1983 (ODA), as amended. These benefits may
include a seven-year period of orphan drug exclusivity upon product
approval, fee reductions, assistance in study design from the FDA,
potential for expedited drug development and eligibility for drug
grants" are forward-looking statements. Forward‐looking statements
by their nature are not guarantees of future performance and are
based upon management's current expectations, estimates,
projections and assumptions. COTI operates in a highly competitive
environment that involves significant risks and uncertainties,
which could cause actual results to differ materially from those
anticipated in these forward‐looking statements. Management of COTI
considers the assumptions on which these forward‐looking statements
are based to be reasonable, but as a result of the many risk
factors, cautions the reader that actual results could differ
materially from those expressed or implied in these forward-looking
statements. Information in this press release should be considered
accurate only as of the date of the release and may be superseded
by more recent information disclosed in later press releases,
filings with the securities regulatory authorities or
otherwise.
Neither TSX
Venture Exchange nor its Regulation Services Provider (as that term
is defined in the policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this
release.
Critical Outcome Technologies Inc.Dr. Wayne DanterPresident
& CEO519-858-5157wdanter@criticaloutcome.comHeisler
CommunicationsTrevor HeislerInvestor
Relations416-500-8061trevor@heislercommunications.com
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