Critical Outcome Technologies Receives Orphan Drug Designation For COTI-2
June 17 2014 - 9:00AM
Marketwired
Critical Outcome Technologies Receives Orphan Drug Designation For
COTI-2
Designation for treatment of ovarian cancer provides further
support for the clinical development of COTI-2
LONDON, ONTARIO--(Marketwired - Jun 17, 2014) - Critical Outcome
Technologies Inc. ("COTI" or the "Company")
(TSX-VENTURE:COT)(OTCQB:COTQF), the bioinformatics and accelerated
drug discovery company, announced today that the U.S. Food and Drug
Administration (FDA) has granted COTI-2 an Orphan Drug Designation
for the treatment of ovarian cancer.
"Receiving the Orphan Drug Designation for COTI-2 speaks to the
need for new treatment options for patients with ovarian cancer,"
said Dr. Wayne Danter, President and CEO. "When current first line
treatments fail, oncologists have limited treatment options to
offer these patients. With its p53 dependent mechanism of action,
COTI-2 is a novel compound with the potential to benefit these
patients, as more than 95% of serious ovarian cancers have a p53
gene mutation. We continue to believe that COTI-2 could represent a
significant therapeutic advantage over treatments currently
available for ovarian and other gynecological cancers."
"This is an important milestone for COTI-2 and brings us one
step closer to bringing this exciting compound to ovarian cancer
patients," said John Drake, Chairman of the Board. "We are looking
forward to moving COTI-2 into the clinic in early 2015 and the
Orphan Drug Designation should prove helpful in our ongoing
dialogue with potential licensees as this drug candidate's
development progresses."
The Orphan Drug Designation may qualify the Company for a number
of benefits under the U.S. Orphan Drug Act of 1983 (ODA), as
amended. These benefits include assistance in study design from the
FDA, potential for expedited drug development, eligibility for
orphan disease development grants, fee reductions, significant tax
credits for clinical trial costs for U.S. based companies, and a
seven-year period of orphan drug exclusivity upon product
approval.
About Orphan Drug
Designation
Under the ODA, 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 U.S. each year, which
potentially provide 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 an FDA orphan drug designation is entitled to a
seven-year exclusive marketing period in the U.S. for that product
and for that indication.
About Critical Outcome
Technologies Inc.
COTI is a leading-edge bioinformatics 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.
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 statements: "… COTI-2 is a novel
compound with the potential to benefit these patients"; "… looking
forward to moving COTI-2 into the clinic in early 2015 and the
Orphan Drug Designation should prove helpful in our ongoing
dialogue with potential licensees as the drug candidate's
development progresses"; and "… may qualify the Company for a
number of benefits under the Orphan Drug Act of 1983 (ODA), as
amended" 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.comwww.criticaloutcome.comHeisler
CommunicationsTrevor HeislerInvestor
Relations416-500-8061trevor@heislercommunications.com
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