RespireRx Pharmaceuticals Inc. to Present at 2017 Rodman &
Renshaw Conference
CEO to Review dronabinol, a Phase III-ready medicine for the
treatment of Obstructive Sleep Apnea, and Provide Pipeline
update
GLEN ROCK, NJ-(Marketwired - Sep 8, 2017) - RespireRx
Pharmaceuticals Inc. (OTCQB: RSPI) ("RespireRx" or the "Company"),
a leader in the development of medicines for the treatment of
respiratory disorders, including sleep apnea, opioid-induced
respiratory depression, and respiratory insufficiency due to spinal
cord injury, announces that the Company's Chief Executive Officer
and Vice Chairman of the Board of Directors, James S. Manuso,
Ph.D., will present at the 2017 Rodman & Renshaw Conference on
Tuesday, September 12, 2017 at 1:45 PM Eastern Time The
presentations will be held at the Palace Hotel in New York,
September 11-12, 2017.
Dr. Manuso will discuss RespireRx's successfully completed Phase
IIB clinical trial of dronabinol in the treatment of obstructive
sleep apnea, and will present the results of a Phase IIA trial
evaluating the ability of CX-1739 (oral) to antagonize the
drug-induced respiratory depression produced by the powerful
opioid, remifentanil. He will also provide updated information and
clinical development plans for the company's pipeline products.
Dr. Manuso's presentation will be available by live webcast
streaming online and will be archived. To access the live audio
webcast, go to http://wsw.com/webcast/rrshq27/rspi. A copy of the
slide presentation to be presented at the conference will be
submitted to the Securities and Exchange Commission in a Current
Report on Form 8-K prior to the presentation and will also be
available in the investors section of the RespireRx website.
About RespireRx Pharmaceuticals Inc. RespireRx Pharmaceuticals
Inc. is a leader in the development of medicines for respiratory
disorders, with a focus on sleep apneas and drug-induced
respiratory depression. The Company has licensed and owns patents
and patent applications, and holds exclusive licenses, for certain
use patents for the use of ampakines for the treatment of
disordered breathing. During the first quarter of 2018, the Company
plans to meet with FDA to discuss its Phase III clinical trial
program to test the safety and efficacy of dronabinol for the
treatment of obstructive sleep apnea.
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, dronabinol. Under a license agreement
with the University of Illinois, the Company has rights to patents
covering the use of cannabinoids for the treatment of sleep-related
breathing disorders. In a double-blind, placebo-controlled,
dose-ascending Phase IIA clinical study, 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). These results were confirmed by a Phase IIB trial at the
University of Illinois at Chicago and Northwestern University in
which dronabinol proved to be safe and efficacious for the
treatment of OSA in a six week, double-blind, placebo-controlled
clinical trial in 56 patients with OSA. This study, which the
University of Illinois completed during the third quarter of 2016,
was fully funded by the National Heart, Lung and Blood Institute of
the National Institutes of Health.
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 receptor sites in the brain. Several ampakines are
being developed by the Company for the treatment of a variety of
breathing disorders. In a recently completed Phase IIA clinical
trial, CX-1739, one of our lead clinical compounds, was shown to
reduce the respiratory depression produced by remifentanil, a
potent opioid, without altering its analgesic effects. In a pilot
study of sleep apnea, CX1739 has demonstrated early promise in the
treatment of central sleep and mixed apneas. The Company plans to
initiate a clinical trial in spinal cord injury patients with
respiratory insufficiency based on positive pre-clinical findings
from studies performed by our collaborators at the University of
Florida.
The Company is also collaborating with academic researchers on
translational research programs to develop the ampakines for the
treatment of orphan diseases, including Pompé Disease, Fragile-X
Syndrome, and perinatal respiratory distress, where the ampakines
have shown effectiveness 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.
Clinical Trial Plans for 2017 - Phase III Clinical Trial plans
for Development of dronabinol
As reported in a press release and on Form 8-K on December 23,
2016, RespireRx announced positive results of the PACE
(Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial
conducted by Drs. David Carley and Phyllis Zee at the University of
Illinois at Chicago and Northwestern University, respectively. The
PACE trial, a Phase 2B study of dronabinol for the treatment of
obstructive sleep apnea ("OSA"), clearly demonstrated that
dronabinol significantly improved the primary outcome measures of
Apnea Hypopnea Index ("AHI"), daytime sleepiness as measured by the
Epworth Sleepiness Scale ("ESS") and overall patient satisfaction
as measured by the Treatment Satisfaction Questionnaire for
Medications ("TSQM"). Based on these results, RespireRx will engage
with FDA in Q1/2018 to agree upon the next steps in connection with
the initiation of a pivotal Phase III clinical trial program
testing the safety and efficacy of dronabinol in the treatment of
obstructive sleep apnea.
Clinical Trial Plans for 2017 - Phase IIB Trial of CX1739 in
Central Sleep Apnea As previously reported, an acute dose of CX1739
improved respiratory function of subjects in a phase IIA trial of
opioid induced respiratory depression using a clinical model of
chronic opioid use. As a follow-up, RespireRx is planning a Phase
II multiple dose study of CX1739 in subjects who are on chronic
opioid therapy. Among patients on chronic opioid therapy for at
least 6 months, the presence of apnea and hypopnea has been
diagnosed in 50% - 75% of patients screened. Initially, these
symptoms usually appear during sleep and are considered, by the
National Institutes of Health (NIH) and the National Institute of
Drug Addiction (NIDA), to be significant risk factors for opioid
addiction and overdose. Therefore, the Phase 2 study is planned to
evaluate the ability of CX1739 treatment to reduce apnea and
hypopnea associated with central sleep apnea.
Comments by the Company's President and Chief Executive Officer
Dr. James S. Manuso, commented, "We look forward to advancing the
many initiatives RespireRx is undertaking throughout the course of
2017. Now that the Company is Phase III-ready with respect to the
final clinical and regulatory development of dronabinol for the
treatment of obstructive sleep apnea, commercialization and
potential partnering plans have been initiated. With dronabinol's
Phase III trial on the horizon, along with the Company's Phase II
ampakines in development, there are numerous strategic and
operational milestones on the calendar. In 2017 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
addition, we will continue to support the scientific research and
pre-clinical development upon which RespireRx is based. I look
forward to reporting to you our progress in the months ahead."
Cautionary Note Regarding Forward-Looking Statements:
This press release contains certain forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934 and
the Company intends that such forward-looking statements be subject
to the safe harbor created thereby. These might include statements
regarding the Company's financial position, business strategy and
other plans and objectives for future operations, and assumptions
and predictions about research and development efforts, including,
but not limited to, preclinical and clinical research design,
execution, timing, costs and results, future product demand,
supply, manufacturing, costs, marketing and pricing factors are all
forward-looking statements.
In some cases, forward-looking statements may be identified
by words including "anticipates," "believes," "intends,"
"estimates," "expects," "plans," and similar expressions include,
but are not limited to, statements regarding (i) future research
plans, expenditures and results, (ii) potential collaborative
arrangements, (iii) the potential utility of the Company's proposed
products, and (iv) the need for, and availability of, additional
financing.
The forward-looking statements included herein are based on
current expectations that involve a number of risks and
uncertainties. These forward-looking statements are based on
assumptions regarding the Company's business and technology, which
involve judgments with respect to, among other things, future
scientific, economic and competitive conditions, and future
business decisions, all of which are difficult or impossible to
predict accurately and many of which are beyond the Company's
control. Although the Company believes that the assumptions
underlying the forward-looking statements are reasonable, actual
results may differ materially from those set forth in the
forward-looking statements. In light of the significant
uncertainties inherent in the forward-looking information included
herein, the inclusion of such information should not be regarded as
a representation by the Company or any other person that the
Company's objectives or plans will be achieved.
Factors that could cause or contribute to such differences
include, but are not limited to, regulatory policies or changes
thereto, available cash, research and development results,
competition from other similar businesses, and market and general
economic factors. This discussion should be read in conjunction
with the condensed consolidated financial statements (unaudited)
and notes thereto included in Item 1 of the Company's current
Quarterly Report on Form 10-Q as of and for the periods ending June
30, 2017 and the Company's Annual Report on Form 10-K for the
fiscal year ended December 31, 2016, including the section entitled
"Item 1A. Risk Factors." The Company does not intend to update or
revise any forward-looking statements to reflect new information,
future events or otherwise.
Company Contact: Jeff Margolis Chief Financial Officer, Senior
Vice-President, Treasurer and Secretary Telephone: (917) 834-7206
E-mail: jmargolis@respirerx.com
RespireRx Pharmaceuticals (PK) (USOTC:RSPI)
Historical Stock Chart
From Mar 2024 to Apr 2024
RespireRx Pharmaceuticals (PK) (USOTC:RSPI)
Historical Stock Chart
From Apr 2023 to Apr 2024