Cortex Pharmaceuticals, Inc. Announces Name Change and Symbol
Change
Provides 2015 Year-End Update and Outlines Clinical Trial Plans
for 2016
GLEN ROCK, NJ-(Marketwired - Dec 17, 2015) - Cortex
Pharmaceuticals, Inc. (OTC: CORX) (the "Company") is providing
investors and shareholders with a 2015 year-end update and a
summary overview of the Company's clinical trial plans for
2016.
Name Change and Symbol Change In keeping with its focus on
respiratory disorders, the Company announced that it has changed
its name to RespireRx Pharmaceuticals Inc. effective as of December
16, 2015. The Company's trading symbol is in the process of
being changed and the new trading symbol requested is "RSRX", or
alternatively "RSPI". The URL for the Company's web-site has
been changed to www.RespireRx.com.
The Company is addressing significant and growing markets for
respiratory disorders, where current treatment options are limited
or inadequate. The Company's product candidate portfolio
includes two clinical stage compounds, dronabinol, which is being
developed for obstructive sleep apnea ("OSA"), and CX1739, which is
being developed for multiple respiratory indications, including
central sleep apnea and drug-induced respiratory depression.
Executive Management Changes in 2015 In August 2015, Dr. James
S. J. Manuso, Ph.D., 66, was appointed as the Company's President
and Chief Executive Officer, as well as Vice Chairman and a member
of the Board of Directors. Dr. Manuso invested $250,000 in the
August 2015 closing of the common stock and warrant financing
discussed below. Dr. Manuso is the former Chairman of the
Board of Directors and Chief Executive Officer of Astex
Pharmaceuticals, Inc., ("Astex") (NASDAQ: ASTX) having served in
such positions from July 2011 through October 2013, at which time
he successfully concluded efforts to sell Astex to Otsuka
Pharmaceuticals, Inc. for $886 million. Dr. Manuso replaced
Dr. Arnold S. Lippa, Ph.D., who is continuing as Executive Chairman
of the Board of Directors and has assumed the position of Chief
Scientific Officer.
Ongoing Phase 2B Clinical Trial of Dronabinol As described in
more detail below, the Company anticipates reporting the results of
an ongoing 120 patient, double-blind, placebo-controlled clinical
trial of dronabinol (9-THC), a synthetic cannabinoid, for use in
the treatment of OSA during the third quarter of 2016.
Clinical Trial Plans for 2016 - Phase 2A Clinical Trial for
CX1739 The Company recently disclosed that it had filed an
Investigational New Drug ("IND") application with the U.S. Food and
Drug Administration ("FDA") to conduct a double-blind,
placebo-controlled, dose-ascending Phase 2A clinical trial in
approximately 18 subjects to determine the ability of orally
administered CX1739, the Company's lead ampakine, to prevent the
respiratory depression produced by remifentanil, a strong opiate,
without altering remifentanil's analgesic properties. The
clinical protocol is designed to evaluate the safety and efficacy
of three escalating doses of CX1739 versus placebo when
administered prior to remifentanil, with respiration, analgesia and
a number of other clinical measures being taken after
administration of both drugs. The clinical trial, to be
conducted at Duke University, is ready for initiation; clinical
supplies have been prepared, a protocol has been written, and the
IRB submission has been prepared.
The commencement of this clinical trial is subject to resolution
of two deficiencies raised by the FDA in its recent clinical hold
letter, as follows:
- The FDA cited a single incidence of mild necrosis in cardiac
tissue from a rat in the highest dose group tested in a 4-week
toxicology study. In that study, histopathology analysis was
performed on the heart tissue only from rats that received placebo
and the highest of three doses of CX1739. In its letter, the
FDA requested that cardiac tissue from all animals in all dosage
groups be analyzed. This analysis has been completed and,
according to two independent, board-certified pathologists, there
does not appear to be any drug-related histopathology and the
original finding most likely was due to "progressive rodent
cardiomyopathy", a syndrome commonly observed in this strain of
rats.
- The FDA requested that the Company perform an additional study
in which rats are to be given a single administration of three
dosages of CX1739, followed by neuro-histopathology evaluation 1, 3
and 14 days after drug administration. In two previous
studies, no neuropathology had been observed after 14 or 28 days of
CX1739 administration at very high doses. The agreed upon
single dose study has begun and is scheduled to be completed by
year end.
The Company intends to utilize the data from the two studies
described above to address and resolve, in early 2016, the two
deficiencies raised by the FDA. Subsequent to such formal
submission, if no further comments are received from the FDA, and
subject to the availability of sufficient working capital
resources, the Company expects to initiate the clinical trial at
the Duke University Clinical Research Unit in the first quarter of
2016 or shortly thereafter, and to complete it in approximately
four months, at an expected cost of approximately $750,000.
The Company will consider expanding its 2016 clinical trial
program based on the availability of additional working capital
resources and the further development of the Company's clinical
stage compounds.
Comments by the Company's President and Chief Executive Officer
Dr. James S. J. Manuso, the Company's President, Chief Executive
Officer and Vice Chairman of the Board of Directors commented, "We
are extremely pleased with the progress that we have achieved on
all fronts over the course of this past year. In 2016 we will
continue to focus on the clinical and regulatory development of the
Company's two proprietary platforms for addressing unmet needs in
the sleep apnea and opioid-induced respiratory depression
markets. In order to reflect our refined research efforts and
clinical focus, we are rebranding Cortex Pharmaceuticals, Inc. as
RespireRx Pharmaceuticals Inc."
Financing Matters Since August 28, 2015, the Company has raised
$1,194,710 in three closings of an offering of units priced at
$0.02103 per unit. Each unit was comprised of one share of the
Company's common stock and a five-year warrant to purchase an
additional two shares of common stock at a price of $0.02103 per
share. This financing is currently scheduled to conclude on or
before December 31, 2015.
As of September 15, 2015, the maturity date of the notes in a
previous note and warrant financing was extended to September 15,
2016. In order to effect the extension, the Company issued
8,903,684 additional warrants, exercisable at $0.035 per share of
common stock, to those note holders. Additionally, at that
time, the Company extended the maturity date of the existing
16,557,142 warrants from that note and warrant offering until
September 15, 2016.
Investor and Industry Conferences The Company presented at
several investor and industry conferences in 2015. Most
recently, the Company presented at the 14th Annual BioInvestor
Conference in San Francisco, California on October 20,
2015. Prior to that, the Company presented at the Rodman &
Renshaw 17th Annual Global Investment Conference, in New York City,
on September 10, 2015, and at the New York BIO 25th Anniversary
Conference in New York City, on May 4, 2015. The Company is
currently scheduled to present at the Biotech Showcase 2016 in San
Francisco, California on January 11, 2016. It is the Company's
intention to present at similar conferences in 2016.
About RespireRx Pharmaceuticals Inc.
The Company is a leader in developing drugs for respiratory
disorders, particularly sleep apneas and drug-induced respiratory
depression. The Company owns patents and patent applications
for certain families of chemical compounds that claim the chemical
structures and their use in the treatment of these and other
disorders.
Drug candidates are currently derived from two platforms, as
described below.
The first platform is the class of compounds known as
cannabinoids, in particular, 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 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 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 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, such drugs have
shown preliminary efficacy in central sleep apnea and in
antagonizing respiratory depression produced by opiates without
altering their analgesic effects. Ampakines also have improved
breathing in animal models of orphan disorders such as Pomp
Disease, spinal cord damage and perinatal respiratory
distress. The Company's compounds belong to a new generation
of ampakines that do not display the undesirable side effects of
earlier versions observed in animal models.
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
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