Current Report Filing (8-k)
02 November 2016 - 12:02AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
Current
Report
Pursuant
to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): November 1, 2016
RESPIRERX
PHARMACEUTICALS INC.
(Exact
name of registrant as specified in its charter)
Delaware
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1-16467
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33-0303583
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(State
or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S.
Employer
Identification No.)
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126
Valley Road, Suite C
Glen
Rock, New Jersey
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07452
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: (201) 444-4947
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item
8.01 Other Events.
RespireRx Pharmaceuticals Inc. (the “Company”)
has received a copy of the Final Progress Report (the “Project Report”) with respect to the project titled “Cannabimimetic
treatment of obstructive sleep apnea: A proof of concept trial” (the “Project”), grant number 5UM1HL112856.
The Company received this Project Report from the National Heart, Lung and Blood Institute of the National Institutes of Health
in response to a Freedom of Information Act (“FOIA”) request. A copy of the Project Report is attached as Exhibit
99.1 to this Current Report on Form 8-K.
As
part of this Project,
the University of Illinois and three other centers conducted a six
week, placebo-controlled Phase 2B clinical trial investigating the effects of dronabinol in patients with obstructive sleep apnea
(the “Clinical Trial”). The Company has licensed from the University of Illinois certain patent rights pertaining
to the use of cannabinoids, including dronabinol, for the treatment of sleep-related breathing disorders such as obstructive sleep
apnea. The Company did not manage or fund this Clinical Trial; this Clinical Trial was fully funded by the National Heart, Lung
and Blood Institute of the National Institutes of Health and is being managed by University of Illinois researchers.
The
Project Report describes preliminary data from three groups of patients who received either of two doses of dronabinol (2.5 or
10 mg) or placebo. The identities of the groups described in the Project Report remain blinded, but the Project Report indicates
that significant group differences were observed in three of four primary outcome measures, including the Apnea-Hypopnea Index
(AHI) and Epworth Sleepiness Scale (ESS). Unblinding of the group identities is expected to occur when the investigators have
completed all planned primary and secondary analyses.
The investigators have indicated that they “anticipate submitting
an abstract detailing at least the top-line findings in December 2016, for presentation at the
Sleep 2017
international
conference of the Associated Professional Sleep Societies.” The investigators also stated they anticipate that they “will
submit a peer-review manuscript detailing these findings in the Winter of 2017.”
The
Company is not involved in the management of the Clinical Trial and takes no position on the information contained in the Project
Report. The Company is providing the Project Report, which is publicly available, to update investors and shareholders with respect
to the information available on the Clinical Trial, which the Company has discussed in its periodic filings with the Securities
and Exchange Commission, including its most recently filed Quarterly Report on Form 10-Q for the quarterly period ended June 30,
2016, as amended.
Item
9.01 Financial Statements and Exhibits
(d)
Exhibits.
A
list of exhibits that are furnished and filed as part of this report is set forth in the Exhibit Index, which is presented elsewhere
in this document, and is incorporated herein by reference.
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Date:
November 1, 2016
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RESPIRERX
PHARMACEUTICALS INC.
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(Registrant)
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By:
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/s/
James S. Manuso
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James
S. Manuso
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President
and Chief Executive Officer
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EXHIBIT
INDEX
Exhibit
Number
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Exhibit
Description
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99.1
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Final
Progress Report, Grant Number 5UM1HL112856
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