RespireRx Pharmaceuticals Inc. Announces Removal of FDA Clinical Hold on CX1739 and Initiation of Phase 2A Clinical Trial by ...
February 29 2016 - 08:00AM
Marketwired
RespireRx Pharmaceuticals Inc. Announces Removal of FDA Clinical
Hold on CX1739 and Initiation of Phase 2A Clinical Trial by March
31, 2016
GLEN ROCK, NJ-(Marketwired - Feb 29, 2016) - RespireRx
Pharmaceuticals Inc. (OTCQB: RSPI) (OTC QB: RSPI as of January 11,
2016; previously OTC QB: CORX) ("RespireRx" or the "Company"), a
leader in developing medicines for respiratory disorders,
particularly sleep apnea and drug-induced respiratory depression,
announced today that it has received notice that the U.S. Food and
Drug Administration (the "FDA") has removed the clinical hold on
the Company's Investigational New Drug application for CX1739,
allowing the initiation of clinical trials. The Company intends to
begin a Phase 2A clinical trial by March 31, 2016 to confirm the
ability of CX1739, the Company's proprietary lead ampakine, to
antagonize the respiratory depressant effects of fentanyl, a potent
opioid, without altering its analgesic properties. This
pharmacological property previously had been reported for CX717, a
predecessor ampakine.
Dr. James S. Manuso, President and Chief Executive Officer of
RespireRx, commented, "We are extremely pleased to announce the
advancement of the clinical and regulatory development of CX1739
for opioid-induced respiratory depression, the first of several
indications involving respiratory disorders. The FDA clearance of
our Phase 2A clinical trial of CX1739 provides further validation
of RespireRx's worldwide leadership role in the research and
development of next-generation ampakine medicines. The RespireRx
management team is committed to further developing its ampakine
portfolio of medicines for a variety of indications where central
nervous system-mediated breathing disorders may play a significant
role, as is the case in Central Sleep Apnea, Pomp Disease and
spinal cord injury. We look forward to reporting on our progress in
the months and years ahead."
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the development of
small molecule medicines for respiratory disorders, with a focus on
sleep apneas and drug-induced respiratory depression. The Company
holds exclusive licenses and owns patents and patent applications
for certain families of chemical compounds that claim the chemical
structures and their use in the treatment of a variety of
disorders, as well as claims for novel uses of known drugs.
RespireRx's pharmaceutical candidates in development are derived
from two platforms, as described below.
The first platform is the class of compounds known as
cannabinoids, in particular, oral dronabinol. Under a license
agreement with the University of Illinois, the Company has rights
to patents claiming the use of cannabinoids for the treatment of
sleep-related breathing disorders. In a double-blind,
placebo-controlled, dose-ascending Phase 2A clinical study
conducted by the Company, dronabinol produced a statistically
significant reduction in the Apnea-Hypopnea Index, the primary
therapeutic end-point, and was observed to be safe and
well-tolerated in a group of patients with Obstructive Sleep Apnea
("OSA"). The University of Illinois and three other centers
currently are investigating dronabinol in a potentially pivotal,
six week, double-blind, placebo-controlled Phase 2B clinical trial
in 120 patients with OSA. This study, which the University of
Illinois has indicated that it expects to be completed during the
second quarter of 2016, is fully funded by the National Heart, Lung
and Blood Institute of the National Institutes of Health. The
Company is not managing or funding this ongoing clinical trial.
The second platform of medicines being developed by RespireRx is
a class of proprietary compounds known as ampakines that act to
enhance the actions of the excitatory neurotransmitter glutamate at
AMPA glutamate receptors. Several ampakines, in both oral and
injectable form, are being developed by the Company for the
treatment of a variety of breathing disorders. In clinical studies,
select ampakines have shown preliminary efficacy in central sleep
apnea and in the control of respiratory depression produced by
opiates, without altering their analgesic effects. In animal models
of orphan disorders, such as Pomp Disease, spinal cord injury and
perinatal respiratory distress, it has been demonstrated that the
ampakines improve breathing function. The Company's compounds
belong to a new class of ampakines that do not display the
undesirable side effects previously reported in animal models of
earlier generations.
Additional information about the Company and the matters
discussed herein can be obtained on the Company's web-site at
www.RespireRx.com or in the Company's filings with the U.S.
Securities and Exchange Commission on EDGAR at www.sec.gov.
Special Note Regarding Forward-Looking Statements: Certain
statements included or incorporated by reference in this news
release, including information as to the future financial or
operating performance of the Company and its drug development
programs, constitute forward-looking statements. The words
"believe," "expect," "anticipate," "contemplate," "target," "plan,"
"intend," "continue," "budget," "estimate," "may," "schedule" and
similar expressions identify forward-looking statements.
Forward-looking statements include, among other things, statements
regarding future plans, targets, estimates and assumptions.
Forward-looking statements are necessarily based upon a number of
estimates and assumptions that, while considered reasonable by the
Company, are inherently subject to significant business, economic
and competitive uncertainties and contingencies. Many factors could
cause the Company's actual results to differ materially from those
expressed or implied in any forward-looking statements made by, or
on behalf of, the Company. Due to these various risks and
uncertainties, actual events may differ materially from current
expectations. Investors are cautioned that forward-looking
statements are not guarantees of future performance and,
accordingly, investors are cautioned not to put undue reliance on
forward-looking statements due to the inherent uncertainty therein.
Forward-looking statements are made as of the date of this news
release and the Company disclaims any intent or obligation to
update publicly such forward-looking statements, whether as a
result of new information, future events or results or
otherwise.
Company Contact: Jeff Margolis Vice-President, Treasurer and
Secretary Telephone: (917) 834-7206 E-mail: jmargolis@respirerx.com
RespireRx Pharmaceuticals Inc. 126 Valley Road, Suite C Glen Rock,
NJ 07452 www.RespireRx.com
RespireRx Pharmaceuticals (PK) (USOTC:RSPI)
Historical Stock Chart
From Feb 2024 to Mar 2024
RespireRx Pharmaceuticals (PK) (USOTC:RSPI)
Historical Stock Chart
From Mar 2023 to Mar 2024