RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

The return of CX-717 --> Interesting info from the 10-K (see below). It turns out the CX-717 artifact phenomenon was seen in the brain (appearance of vacuoles in certain brain regions) and is believed to be a "post-mortem artifact due to the exposure of a CX717 metabolite to formaldehyde, the chemical agent used to fix the brain tissue". The company is "preparing this data for publication in a peer-reviewed journal and intends to submit a new Investigational New Drug (“IND”) application to the FDA in the second half of 2016."

So this explains the inclusion of CX-717 in Dr. Manuso's presentation slides as the compound they plan to advance as an Ampakine/opioid combo drug. They're going to submit a new IND for CX-717 to the FDA.

Even though the comp of matter patent on CX-717 runs out in 2017, it could be that the combo version (CX-717 plus opioid) might effectively extend that patent (?). Not sure, but in any event the existing method of use patents go to 2027 and they have more of them coming.

So this is great news if they can get the FDA to go along with approving the IND for CX-717. The head of the FDA division who was so anti CX-717 years ago may be gone by now, and it's probably a completely different FDA division anyway (respiratory vrs ADHD) that will be making the decision. If the IND is approved, this is great news and will save a lot of development time. So who da thunk it?? CX-717 gets another chance. The artifact notwithstanding, it was a great compound -



http://www.sec.gov/Archives/edgar/data/849636/000149315216008331/form10-k.htm



>>> Although the development of CX717 has been delayed due to regulatory issues with the FDA, and despite the impending loss of U.S. patents in 2017 and international patents in 2018 claiming composition-of-matter and certain non-respiratory uses, nevertheless, the Company believes that CX717 stills retains considerable value as a potential commercial product, for the following reasons. Patents claiming the use of CX717 for the treatment of various respiratory disorders are in effect in the United States and elsewhere at least through 2027 and additional method of treatment patents are planned and are being prepared. Long term preclinical safety studies have been completed and are sufficient to support chronic dosing of CX717 in humans. CX717 has demonstrated the ability to antagonize the respiratory effects of fentanyl, a potent opioid, in two clinical trials. Promising results have also been observed in clinical trials of attention deficit hyperactivity disorder and cognition. Finally, the Company has obtained what it believes to be conclusive data showing that the presumed neurotoxicity observed after administration of very high doses of CX717 (i.e., appearance of vacuoles in certain brain regions) is a post-mortem artifact due to the exposure of a CX717 metabolite to formaldehyde, the chemical agent used to fix the brain tissue. The Company is preparing this data for publication in a peer-reviewed journal and intends to submit a new Investigational New Drug (“IND”) application to the FDA in the second half of 2016. <<<