SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 19, 2016
RESPIRERX PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)
or other jurisdiction
126 Valley Road, Suite C
Glen Rock, New Jersey
|(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 January 19, 2016, the Company announced that that it has reached an agreement with the Medications Development Program of the National Institute of Drug Abuse (“NIDA”) to conduct research on RespireRx ampakines CX717 and CX1739. The Agreement was entered into as of October 19, 2015, and on January 14, 2016, the Company and NIDA approved the proposed protocols, allowing research activities to commence. NIDA will evaluate the compounds using pharmacologic, pharmacokinetic and toxicologic protocols to determine the potential effectiveness of the ampakines for the treatment of drug abuse and addiction. Initial studies will focus on cocaine and methamphetamine addiction and abuse, and will be contracted to outside testing facilities and/or government laboratories, with all costs to be paid by NIDA. RespireRx will provide NIDA with supplies of CX717 and CX1739 and will work with the NIDA staff to refine the protocols and dosing parameters. RespireRx will retain all intellectual property, proprietary and commercialization rights to these compounds.
The above description of the agreement with the NIDA does not purport be complete and is qualified by reference to the agreement itself which appears as Exhibit 99.1 to this Current Report on Form 8-K. The press release announcing the Company’s participation in the conference is attached as Exhibit 99.2.
Item 9.01 Financial Statements and 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.
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: January 19, 2016|
|By:||/s/ James S. J. Manuso|
James S. J. Manuso
President and Chief Executive Officer
|Exhibit Number||Exhibit Description|
|99.1||Agreement between the Company and the Medications Development Program of the National Institute of Drug Abuse|
|99.2||Press Release dated January 19, 2016*|
* Furnished herewith.
National Institute on Drug Abuse
Medications Development Program
STANDARD AGREEMENT FOR SUBMITTING COMPOUNDS FOR
PRECLINICAL PHARMACOLOGICAL, PHARMACOKINETIC
AND TOXICOLOGICAL EVALUATION
THIS AGREEMENT, made and entered into on the 19th day of October, 2015, by and between the National Institute on Drug Abuse (hereinafter referred to as “NIDA”), a component of the National Institutes of Health (NIH); and Cortex Pharmaceuticals, a corporation having executive offices at _126 Valley Rd. Suite C Glen Rock, NJ 07452, (hereinafter referred to as “COMPANY”);
WHEREAS, COMPANY is the owner of allosteric modulators of the AMPA receptor, called Ampakines (hereinafter referred to as “COMPOUNDS”) and certain proprietary information pertaining thereto, which may be useful in the treatment of drug abuse and drug addiction;
WHEREAS, NIDA has certain conventional preclinical assays (hereinafter referred to as “CONVENTIONAL TESTS”) which may be useful in the pharmacological, pharmacokinetic, and toxicological evaluation of compounds which may prove effective in the treatment of drug abuse and drug addiction.
WHEREAS, COMPANY wishes to have its proprietary compounds tested by NIDA in CONVENTIONAL TESTS and not administered to humans, and
WHEREAS, the parties wish to enter into arrangements to be used in the confidential testing of COMPANY compounds by NIDA;
NOW THEREFORE, the parties agree as follows:
Article 1. From time to time COMPANY will supply to a facility under contract to NIDA (hereinafter referred to as a “NIDA CONTRACTOR”) or to a Government laboratory designated by NIDA, the above-mentioned COMPOUNDS and/or other compositions of matter patented or unpatented, for testing so that NIDA may evaluate the pharmacological, pharmacokinetic, and toxicological properties of such COMPOUNDS for preclinical evaluation for potential use as medications for the treatment of drug abuse and drug addiction. COMPANY shall have the right to review all protocols used in testing of COMPOUNDS.
Information relating to the COMPOUNDS themselves, including their chemical structure or other identifiers, their physical properties, their biological activity, and the identity of the provider of COMPOUNDS, will be provided to NIDA by COMPANY and appropriately marked as “Confidential” (hereinafter referred to as “COMPANY CONFIDENTIAL INFORMATION”). Information will be generated on COMPOUNDS by NIDA CONTRACTORS and/or Government Laboratories using CONVENTIONAL TESTS (hereinafter referred to as “NIDA DATA”).
Article 2. In order to facilitate the record keeping and handling of COMPANY CONFIDENTIAL INFORMATION the parties agree as follows:
a. At the time COMPANY supplies COMPOUNDS pursuant to Article 1, COMPANY shall forward to NIDA’s Division of Pharmacotherapies and Medical Consequences of Drug Abuse (hereinafter referred to as “DPMCDA”) a data sheet for each COMPOUND giving pertinent available data as to chemical formula, structure, purity, solubility, melting point, other physical characteristics, stability, toxicity, and precautions which need to be followed in handling and storing of the COMPOUND. After authorization from DPMCDA, COMPANY shall ship the COMPOUND(s) directly to the NIDA CONTRACTOR specified by DPMCDA.
b. DPMCDA will inform COMPANY which COMPOUNDS are new to DPMCDA and which submitted COMPOUNDS duplicate any COMPOUNDS previously existing in NIDA’s structure-activity database.
c. COMPANY CONFIDENTIAL INFORMATION will not be disclosed by NIDA unless required by law. Only those FEDERAL GOVERNMENT or NIDA CONTRACTOR employees with a need to know will have access to COMPANY CONFIDENTIAL INFORMATION.
d. NIDA shall require that COMPANY CONFIDENTIAL INFORMATION will be retained by NIDA CONTRACTORS, and shall not be released, published, or disclosed without the written consent of NIDA after consultation with COMPANY.
e. NIDA shall make no use of the COMPOUNDS and COMPANY CONFIDENTIAL INFORMATION other than for purposes stated in Article 1 without COMPANY’s written permission.
f. NIDA shall return to COMPANY and eliminate from the NIDA testing process any COMPOUND that COMPANY may designate prior to commencement of CONVENTIONAL TESTS.
g. The foregoing restrictions on use and disclosure of COMPANY CONFIDENTIAL INFORMATION hereunder shall not apply to any information which was in NIDA’s possession or control prior to the date of COMPANY’s disclosure or to any information which is in the public domain through no improper act on the part of NIDA, its employees or contractors, or which is available without restriction from any source, including COMPANY.
Article 3. COMPANY, in voluntarily supplying COMPOUNDS hereunder, is entitled to protection for the research and development work it has done and for any COMPANY CONFIDENTIAL INFORMATION, while NIDA has the responsibility to facilitate the development of medications for the treatment of drug abuse and drug addiction. Accordingly, the parties agree as follows:
a. NIDA agrees that all preexisting rights in those COMPOUNDS in which COMPANY has a proprietary interest shall remain in COMPANY. Inasmuch as this Agreement concerns only the evaluation of COMPANY’s COMPOUNDS in CONVENTIONAL TESTS, NIDA recognizes that the mere performance of said CONVENTIONAL TESTS and nothing more does not constitute invention.
b. Contracts between NIDA and NIDA CONTRACTORS carrying out CONVENTIONAL TESTS on submitted COMPOUNDS, will contain terms to implement the provisions of this Agreement relating to NIDA CONTRACTORS and to safeguard the rights of COMPANY under this Agreement.
c. NIDA shall be informed in writing whenever COMPANY desires to include NIDA DATA in any publication, and appropriate credit shall be given to the Division of Pharmacotherapies and Medical Consequences of Drug Abuse, NIDA.
Article 4. As soon as NIDA DATA is reported to NIDA, NIDA agrees to provide this information to COMPANY. If a COMPOUND is found to exhibit properties that suggest its potential for safe use in the treatment of drug abuse and drug addiction, NIDA will advise COMPANY to that effect.
Article 5. It is understood that COMPANY shall not be liable to the Government for any claims or damages which may result from the testing of COMPOUNDS while in NIDA’s or the NIDA CONTRACTORS’ custody, except if claims or damages are the result of negligence on the part of COMPANY.
Article 6. In performing the CONVENTIONAL TESTS hereunder, NIDA and NIDA CONTRACTORS shall function independently and not as employees or agents of COMPANY.
Article 7. The construction, validity, performance, and effect of this Agreement shall be governed by Federal law, as applied by the Federal Courts in the District of Columbia.
Article 8. This Agreement shall become effective upon the date hereinabove set forth.
SIGNATURES ON NEXT PAGE
Acceptance of the foregoing terms and conditions shall be indicated in duplicate by signatures below of the authorized representatives of each party.
COMPANY: Cortex Pharmaceuticals
|/s/ Richard Purcell||Date: 10/19/15|
|Name (Type or Print): Richard Purcell|
|Title: Senior Vice President|
COMPANY Department: Research & Development
COMPANY Name: RespireRx Pharmaceuticals
COMPANY Address: 126 Valley Rd, Suite C, Glen Rock, NJ 08542
NATIONAL INSTITUTE ON DRUG ABUSE:
|/s/ Nora D. Volkow||Date: 10/21/2015|
Nora D. Volkow, M.D.
National Institute on Drug Abuse
Neuroscience Center, Room 4123
6001 Executive Boulevard, MSC 9551
Bethesda, Maryland 20892-9551
RespireRx Pharmaceuticals Inc. Announces New Research Program with the National Institute of Drug Abuse
RespireRx Expands Research Initiatives Involving Treatments for Drugs of Abuse
Glen Rock, N.J., January 19, 2016/Globe Newswire - RespireRx Pharmaceuticals Inc. (OTC: RSPI) (“RespireRx” or the “Company”) announces that the Company has reached agreement with the Medications Development Program of the National Institute of Drug Abuse (“NIDA”) for NIDA to conduct research on RespireRx compounds CX717 and CX1739. Pursuant to this program, NIDA will evaluate the Company’s proprietary ampakine compounds in a series of preclinical pharmacologic, pharmacokinetic and toxicologic protocols to determine their potential effectiveness for the treatment of drug abuse and addiction. Initial studies will focus on cocaine and methamphetamine addiction and abuse and be contracted to outside testing facilities and/or government laboratories, with all costs to be paid by NIDA. RespireRx will provide NIDA with supplies of CX1739 and CX717 and will work with the NIDA staff to refine the protocols and dosing parameters for these animal models of addiction. RespireRx will retain all intellectual property, proprietary and commercialization rights to these compounds.
The Company’s participation in the Medications Development Program follows the completion of a National Institutes of Health Small Business Innovation Research (“SBIR”) contract with NIDA to evaluate the ability of CX1942, another ampakine compound, to antagonize the respiratory depression induced by the opiate fentanyl.
“In keeping with our strategic focus on developing drugs for respiratory indications, the Company is seeking to realize the full value of its compounds by working with development partners to fund the non-respiratory uses of its compounds,” said Dr. Arnold Lippa, Executive Chairman and Chief Scientific Officer of RespireRx.
Richard Purcell, Senior Vice President, Research and Development, for RespireRx, added, “Through non-dilutive grants and partnerships with government agencies like NIDA, the Company is able to advance the development of its ampakine compounds for unmet clinical needs, not only in the field of respiratory disorders, but also in the related fields of addiction and other central nervous system disorders.”
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the development of drugs 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 Pharmaceuticals Inc. 126 Valley Road, Suite C, Glen Rock, NJ 07452
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. 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 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, which 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 damage and perinatal respiratory distress, it has been demonstrated that certain 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.
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.
Vice-President, Treasurer and Secretary
Telephone: (917) 834-7206
RespireRx Pharmaceuticals Inc. 126 Valley Road, Suite C, Glen Rock, NJ 07452