RespireRx Pharmaceuticals Inc. Announces Positive Results from
Phase 2B PACE Study Conducted by the University of Illinois
Dronabinol Reduces Symptoms of Obstructive Sleep Apnea
GLEN ROCK, NJ-(Marketwired - Dec 23, 2016) - RespireRx
Pharmaceuticals Inc. (OTCQB: RSPI) ("RespireRx" or the "Company"),
is pleased to announce positive results of the PACE
(Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial
conducted by Dr. David Carley and colleagues at the University of
Illinois at Chicago and Northwestern University. The PACE trial, a
Phase 2B study of dronabinol for the treatment of obstructive sleep
apnea ("OSA"), clearly demonstrates that dronabinol significantly
improves 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").
In a dose dependent fashion, treatment with 2.5 mg and 10 mg
dronabinol once a day at night significantly reduces the Apnea
Hypopnea Index ("AHI"), a measure of breathing abnormalities during
sleep, in 56 patients with moderate to severe OSA who completed the
study. Of these, 17 received placebo, 19 received the 2.5 mg dose
and 20 received the 10 mg dose. Compared to average baseline AHI
values of 26 + 12, six weeks of dronabinol administration to
moderate to severe OSA patients reduced AHI values, compared to
placebo, by 9.7 + 4 for the 2.5 mg dose and 13.2 + 4 for the 10 mg
dose (p=.02 and p=.001, respectively, compared to control).
Furthermore, treatment with 10 mg dronabinol significantly improved
daytime sleepiness as measured by the ESS (p = 0.0001, compared to
placebo) and achieved the greatest overall patient satisfaction
with treatment (p=.02) as measured by the TSQM.
Arnold Lippa, Ph.D., Chief Scientific Officer and Executive
Chairman commented, "We congratulate Dr. Carley and his colleagues
at both the University of Illinois at Chicago and Northwestern
University for the successful completion of the PACE trial. These
positive results clearly demonstrate the potential for dronabinol
to treat OSA, a serious condition affecting millions of people with
very few viable treatment options. We plan to move forward with the
development of dronabinol in OSA, and plan to meet with the FDA for
a Special Protocol Assessment ("SPA") to finalize the Phase 3 study
required for approval using both fast track and breakthrough
designations from the FDA to facilitate the development path."
James S. Manuso, Ph.D., President, Chief Executive Officer and
Vice Chairman stated, "We are very excited with the possibility of
bringing to market the first drug treatment for OSA. We can now
envision a small molecule, easy to use, oral medicine for OSA
patients as an alternative to CPAP (continuous positive airway
pressure) devices, surgery and other methods used to treat this
underappreciated disease, which has such enourmous costs to
society."
"We look forward to discussing with investors the results of
this trial at upcoming conferences."
Background
Obstructive Sleep Apnea is the most common form of sleep apnea
and affects 29.4 million Americans according to Frost &
Sullivan. 5.9 million adults are diagnosed (23.5 million are
undiagnosed). OSA, besides causing next day sleepiness which is a
major cause of motor vehicle and industrial accidents, is also
co-morbid with cardiovascular disease, type 2 diabetes and other
conditions. Treatment options are limited and the most effective
treatment, the CPAP device has an extremely high non-compliance
rate. The overall cost to the U.S. economy of the diagnosed and
undiagnosed portions of the OSA market are estimated to be $12.4
billion and $149.6 billion respectively for a total cost of $162.0
billion in 2015. There is no drug therapy approved for OSA. While
certain stimulants such as modafinil and methylphenidate are FDA
approved for next day sleepiness in certain OSA patients, they do
not treat OSA itself. Dronabinol, currently formulated as a
capsule, is believed to be much more user friendly than the current
devices, should have a higher patient compliance rate, should work
well in the moderate to mild patient segment, which represents
approximately 50% of the overall OSA patient population, and may
result in more of the currently undiagnosed patient population
getting diagnosed.
Dronabinol is synthetic 9-THC (delta 9-tetrahydrocannabinol),
one of the active cannabinoids found in marijuana. It is approved
in the United States in 2.5mg, 5mg and 10mg capsules for the
treatment of anorexia associated with AIDS and chemo-therapy
induced nausea and vomiting. It is a schedule III drug meaning
there is a low abuse potential, but it is monitored by the United
States DEA (drug enforcement agency). It is Medicare part B
reimbursed for its current approved indications. Use of dronabinol
for the treatment of OSA is novel.
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 holds exclusive licenses and
owns patents and patent applications or rights thereto for certain
families of chemical compounds that claim the chemical structures
and their uses in the treatment of a variety of disorders, as well
as claims for novel uses of known drugs.
RespireRx has a pipeline of medicines in Phase 2 clinical
development focused on pharmaceutical treatments for a variety of
breathing disorders. Clinical development in the area of
respiratory disorders, particularly drug-induced respiratory
depression and sleep apnea, has created opportunities for the
development and commercialization of the Company's compounds.
Cannabinoids. One platform being developed by RespireRx is the
class of compounds known as cannabinoids, including 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.
Ampakines. The other platform of proprietary medicines being
developed by RespireRx are ampakines, which act to enhance the
actions of the excitatory neurotransmitter glutamate at AMPA
glutamate receptors. Several ampakines, in both oral and injectable
forms, 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 opioids,
without altering the opioid analgesic effects. In animal models of
orphan disorders, such as Pompe Disease, spinal cord injury and
perinatal respiratory distress, it has been demonstrated that
certain ampakines improve breathing function. The Company's
compounds belong to a new class that does not display the
undesirable side effects previously reported for other
ampakines.
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 Securities
and Exchange Commission at www.sec.gov.
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 press release should be read in conjunction
with the condensed consolidated financial statements (unaudited)
and notes thereto included in Item 1 of the Company's recently
filed Quarterly Report on Form 10-Q and 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." 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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