Current Report Filing (8-k)
December 23 2016 - 9:01AM
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): December 23, 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.
On
December 23, 2016 the Company issued a press release announcing unblinded data, received from the University of Illinois at Chicago,
regarding the Phase 2B PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial. That press release is
attached
as Exhibit 99.1 to this Current Report on Form 8-K.
The
PACE trial was conducted by
the University of Illinois at Chicago and Northwestern University.
This was a six week, placebo-controlled Phase 2B clinical trial investigating the effects of dronabinol in patients with moderate
to severe obstructive sleep apnea. 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, which was fully funded by grant number 5UM1HL112856 from the National
Heart, Lung and Blood Institute of the National Institutes of Health (“NIH”) and was managed by University of Illinois
at Chicago researchers.
On
November 1, 2016, the Company filed a Current Report on Form 8-K attaching the
Final
Progress Report (the “Project Report”) to the NIH, which contained blinded data for the PACE trial. The Project Report
indicated that the principal investigators anticipated submitting an abstract for presentation at the
Sleep 2017
international
conference of the Associated Professional Sleep Societies, as well as a peer-review manuscript detailing the findings in the winter
of 2017.
The
Company is providing the press release, to update investors and shareholders with respect to the information available on this
Phase 2B 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 September 30, 2016, as amended.
Item
9.01 Financial Statements and Exhibits
(d)
Exhibits.
A
list of exhibits furnished 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:
December 23, 2016
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RESPIRERX PHARMACEUTICALS INC.
(Registrant)
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By:
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/s/
James S. Manuso
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James
S. Manuso
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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Press
Release dated December 23, 2016
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