RespireRx Pharmaceuticals Inc. to Present at 9th Annual Biotech
Showcase(TM) 2017
CEO to Review Completed Phase 2B Dronabinol Clinical Trial for
the Treatment of Obstructive Sleep Apnea and Provide Pipeline
Update
GLEN ROCK, NJ-(Marketwired - Jan 6, 2017) - RespireRx
Pharmaceuticals Inc. (OTCQB: RSPI) ("RespireRx" or the "Company"),
a leader in the development of medicines for the treatment of
respiratory disorders, particularly sleep apneas and drug-induced
respiratory depression for which there are no approved
pharmaceuticals, announces that the Company's President, Chief
Executive Officer and Vice Chairman of the Board of Directors,
James S. Manuso, Ph.D., will present at the Biotech Showcase™ 2017
on Monday, January 9, 2017 at 2:30 P.M. Pacific Standard Time, Room
7, Ballroom Level. The Biotech Showcase is co-sponsored by the EBD
Group and Demy-Colton Life Sciences Advisors. Presentations will be
held at the Hilton San Francisco Union Square Hotel in San
Francisco, California from January 9 - 11, 2017.
Dr. Manuso will present the positive results from the recently
completed Phase 2B "PACE" clinical trial of dronabinol in the
treatment of obstructive sleep apnea ("OSA"). He will provide an
overview of the clinical trial data, and will outline the Company's
plans to meet with the U.S. Food and Drug Administration ("FDA") in
mid-year 2017 for an end of Phase 2 meeting at which the Company
plans to obtain guidance for a Phase 3 clinical protocol that will
enable the Company to bring dronabinol to market for the treatment
of OSA. The Company will request a Special Protocol Assessment to
clearly define a path to approval of a new drug application ("NDA")
by the FDA, and will seek fast-track and breakthrough designations
for dronabinol in the treatment of OSA.
Dr. Manuso also will discuss the successful results from the
Phase 2A clinical trial of CX1739 in the prevention of
opioid-induced respiratory depression. Based on these results,
RespireRx plans to conduct a Phase 2 study of CX1739 for the
treatment of opioid-induced central sleep apnea ("CSA") in a
controlled post-surgical setting where opioids are used for pain
management. In addition, based on promising preclinical studies,
the Company plans to re-commence the clinical development program
for CX717 in the treatment of respiratory distress associated with
spinal cord injury, an orphan indication.
Dr. Manuso's presentation will be available by live webcast
streaming online. To access the live webcast, go to
https://event.webcasts.com/starthere.jsp?ei=113090... (where it
will also be archived for three months) or go to the Company's
website at www.respirerx.com, click on the investors tab and follow
the link and instructions. A copy of the slide presentation to be
presented at the Biotech Showcase 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.
Comments by the Company's President and Chief Executive Officer
Dr. James S. Manuso commented, "We look forward to advancing the
many initiatives RespireRx has in the pipeline throughout the
course of 2017. Now that the Company is planning the Phase 3
clinical and regulatory development of dronabinol for the treatment
of OSA, we are considering various potential commercialization and
partnering opportunities. With dronabinol's Phase 3 clinical trial
on the horizon, along with the ampakines in Phase 2 clinical
development, there are numerous strategic and operational
milestones on the calendar. We will continue to focus on the
clinical and regulatory development of the Company's two
proprietary platforms for addressing unmet needs in the markets for
sleep apnea, opioid-induced respiratory depression and other forms
of respiratory distress. In addition, we will continue to support
the scientific research and pre-clinical development upon which our
company is based. I look forward to reporting to you our progress
in the months ahead."
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 owns patents and patent
applications, and holds exclusive licenses for certain families of
chemical compounds, that claim the chemical structures and their
use in the treatment of these and other disorders.
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
claiming the use of cannabinoids for the treatment of sleep-related
breathing disorders. As reported in a press release and in a
Current Report on Form 8-K on December 23, 2016, RespireRx
announced positive results of the PACE (Pharmacotherapy of Apnea by
Cannabimimetic Enhancement) clinical trial conducted by Dr. David
Carley and colleagues at the University of Illinois at Chicago and
Northwestern University. The PACE clinical trial, a Phase 2B
double-blind, placebo controlled clinical study of 2.5mg and 10mg
doses of dronabinol for the treatment of OSA, clearly demonstrated
that dronabinol significantly improved the primary outcome measures
of the 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"). This clinical study was
fully funded by the National Heart, Lung and Blood Institute of the
National Institutes of Health. The Company did not manage or fund
this clinical trial. In an earlier double-blind,
placebo-controlled, dose-ascending Phase 2A clinical study
conducted by the Company, dronabinol produced a statistically
significant reduction in the AHI, the primary therapeutic
end-point, and was observed to be safe and well-tolerated in a
group of patients with OSA.
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 in
both oral and injectable form are being developed by the Company
for the treatment of a variety of breathing disorders. In a
recently completed Phase 2A clinical trial, orally administered
CX1739 antagonized the respiratory depression produced by
remifentanil, a potent opioid, without altering its analgesic
effects. In an additional Phase 2A clinical trial, single dose
administration of CX1739 demonstrated preliminary efficacy in
reducing CSA. In published studies, ampakines have improved
disordered breathing in animal models of orphan disorders such as
spinal cord damage, Pompé Disease and perinatal respiratory
distress.
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 at www.sec.gov.
Special Note Regarding Forward-Looking Statements: This news
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. 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 news release should be read in conjunction
with the Company's Annual Report on Form 10-K for the fiscal year
ended December 31, 2015, including the section entitled "Item 1A.
Risk Factors," as well as the Company's Quarterly Report on Form
10-Q for the quarterly period ended September 30, 2016. 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 Vice-President, Treasurer and
Secretary Telephone: (917) 834-7206 E-mail:
jmargolis@respirerx.com
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