Critical Outcome Technologies Receives Orphan Drug Designation For COTI-2
June 17 2014 - 9:00AM
Marketwired Canada
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(R), 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.
FOR FURTHER INFORMATION PLEASE CONTACT:
Critical Outcome Technologies Inc.
Dr. Wayne Danter
President & CEO
519-858-5157
wdanter@criticaloutcome.com
www.criticaloutcome.com
Heisler Communications
Trevor Heisler
Investor Relations
416-500-8061
trevor@heislercommunications.com
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