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): February 29, 2016

 

RESPIRERX PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

 

Delaware   1-16467   33-0303583
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (I.R.S Employer
Identification No.)

 

126 Valley Road, Suite C

Glen Rock, New Jersey

  07452
(Address of principal executive offices)   (Zip Code)

 

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:

 

[  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
[  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
[  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
[  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 
 

  

Item 7.01 Regulation FD Disclosure

 

On February 29, 2016, the Company announced that it has received notice that the U.S. Food and Drug Administration has removed the clinical hold on the Company’s Investigational New Drug application for CX1739, allowing for the initiation of clinical trials. The Company intends to begin a Phase 2A clinical trial by March 31, 2016 to confirm the ability of CX1739, the Company’s proprietary lead ampakine, to antagonize the respiratory depressant effects of fentanyl, a potent opioid, without altering its analgesic properties.

 

The press release announcing the removal of the clinical hold and the Company’s intention to proceed with a clinical trial is attached as Exhibit 99.1.

 

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.

 

Cautionary Statement

 

Statements in this report that are “forward-looking statements” within the meaning of the federal securities laws, including the Company’s expectations and beliefs about its recording of revenue and the effects of any misreporting on its financial statements, are based on currently available information. Terminology such as “believe,” “expect,” “intend,” “estimate,” “project,” “anticipate,” “will” or similar statements or variations of such terms are intended to identify forward-looking statements, although not all forward-looking statements contain such terms. These forward-looking are subject to a number of risks, uncertainties and other factors that could cause the Company’s actual results, performance, prospects or opportunities in 2015 and beyond to differ materially from those expressed in, or implied by, these forward-looking statements. These risks include the risks referenced in the Company’s most recently filed Annual Report on Form 10-K or as may be described from time to time in the Company’s subsequent filings with the Securities and Exchange Commission; and such factors are incorporated by reference herein.

  

 
 

  

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.

 

  RESPIRERX PHARMACEUTICALS INC.
     
Date: February 29, 2016    
  By: /s/ James S. J. Manuso
    James S. J. Manuso
    President and Chief Executive Officer

  

 
 

  

EXHIBIT INDEX

 

Exhibit
Number
  Exhibit Description
99.1   Press Release dated February 29, 2016*

 

* Furnished herewith.

  

 
 

  

 

 

 

 

 

 

 

  

RespireRx Pharmaceuticals Inc. Announces Removal of FDA Clinical Hold on CX1739 and Initiation of Phase 2A Clinical Trial by March 31, 2016

 

Glen Rock, N.J., Feb. 29, 2016/ Marketwired – RespireRx Pharmaceuticals Inc. (OTC QB: RSPI as of January 11, 2016; previously OTC QB: CORX) (“RespireRx” or the “Company”), a leader in developing medicines for respiratory disorders, particularly sleep apnea and drug-induced respiratory depression, announced today that it has received notice that the U.S. Food and Drug Administration (the “FDA”) has removed the clinical hold on the Company’s Investigational New Drug application for CX1739, allowing the initiation of clinical trials. The Company intends to begin a Phase 2A clinical trial by March 31, 2016 to confirm the ability of CX1739, the Company’s proprietary lead ampakine, to antagonize the respiratory depressant effects of fentanyl, a potent opioid, without altering its analgesic properties. This pharmacological property previously had been reported for CX717, a predecessor ampakine.

 

Dr. James S. Manuso, President and Chief Executive Officer of RespireRx, commented, “We are extremely pleased to announce the advancement of the clinical and regulatory development of CX1739 for opioid-induced respiratory depression, the first of several indications involving respiratory disorders. The FDA clearance of our Phase 2A clinical trial of CX1739 provides further validation of RespireRx’s worldwide leadership role in the research and development of next-generation ampakine medicines. The RespireRx management team is committed to further developing its ampakine portfolio of medicines for a variety of indications where central nervous system-mediated breathing disorders may play a significant role, as is the case in Central Sleep Apnea, Pompé Disease and spinal cord injury. We look forward to reporting on our progress in the months and years ahead.”

 

About RespireRx Pharmaceuticals Inc.

 

RespireRx Pharmaceuticals Inc. is a leader in the development of small molecule 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 for certain families of chemical compounds that claim the chemical structures and their use in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.

 

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, oral 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. In a double-blind, placebo-controlled, dose-ascending Phase 2A clinical study conducted by the Company, 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”). The University of Illinois and three other centers currently are investigating dronabinol in a potentially pivotal, six week, double-blind, placebo-controlled Phase 2B clinical trial in 120 patients with OSA. This study, which the University of Illinois has indicated that it expects to be completed during the second quarter of 2016, is fully funded by the National Heart, Lung and Blood Institute of the National Institutes of Health. The Company is not managing or funding this ongoing clinical trial.

 

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 receptors. Several ampakines, in both oral and injectable form, 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 opiates, without altering their analgesic effects. In animal models of orphan disorders, such as Pompé Disease, spinal cord injury and perinatal respiratory distress, it has been demonstrated that the ampakines improve breathing function. The Company’s compounds belong to a new class of ampakines that do not display the undesirable side effects previously reported in animal models of earlier generations.

 

RespireRx Pharmaceuticals Inc., 126 Valley Road, Suite C, Glen Rock, NJ 07452

www.RespireRx.com

 

 
 

  

 

   

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.

 

Special Note Regarding Forward-Looking Statements: Certain statements included or incorporated by reference in this news release, including information as to the future financial or operating performance of the Company and its drug development programs, constitute forward-looking statements. The words “believe,” “expect,” “anticipate,” “contemplate,” “target,” “plan,” “intend,” “continue,” “budget,” “estimate,” “may,” “schedule” and similar expressions identify forward-looking statements. Forward-looking statements include, among other things, statements regarding future plans, targets, estimates and assumptions. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Many factors could cause the Company’s actual results to differ materially from those expressed or implied in any forward-looking statements made by, or on behalf of, the Company. Due to these various risks and uncertainties, actual events may differ materially from current expectations. Investors are cautioned that forward-looking statements are not guarantees of future performance and, accordingly, investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. Forward-looking statements are made as of the date of this news release and the Company disclaims any intent or obligation to update publicly such forward-looking statements, whether as a result of new information, future events or results or otherwise.

 

Company Contact:

 

Jeff Margolis
Vice-President, Treasurer and Secretary

Telephone: (917) 834-7206
E-mail: jmargolis@respirerx.com

 

RespireRx Pharmaceuticals Inc., 126 Valley Road, Suite C, Glen Rock, NJ 07452

www.RespireRx.com