RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

Drfreely, It's still too early to make funeral arrangements for CX-1739, but it sure is frustrating. After the CX-717 problem, Cortex did very rigorous preclinical testing on CX-1739 and found no presence of the cellular phenomenon, though it was reportedly found in various other Ampakine compounds and not in others. Very strange, and even more mysterious since I don't think Cortex ever revealed what the observed cellular changes were or in what tissue type they were found.

The recent press release said - >>> "progressive rodent cardiomyopathy", a syndrome commonly observed in this strain of rats. <<< So it could just be a fluke. Problem is, how many unexplained flukes or artifacts before nobody wants to ever partner an Ampakine program again? It isn't as if Ampakines are the most popular area for pharma research, on the contrary.

Perhaps Neuro will chime in with some insights into the situation -



https://finance.yahoo.com/news/cortex-pharmaceuticals-inc-announces-name-130000915.html



>>> The commencement of this clinical trial is subject to resolution of two deficiencies raised by the FDA in its recent clinical hold letter, as follows:

•The FDA cited a single incidence of mild necrosis in cardiac tissue from a rat in the highest dose group tested in a 4-week toxicology study. In that study, histopathology analysis was performed on the heart tissue only from rats that received placebo and the highest of three doses of CX1739. In its letter, the FDA requested that cardiac tissue from all animals in all dosage groups be analyzed. This analysis has been completed and, according to two independent, board-certified pathologists, there does not appear to be any drug-related histopathology and the original finding most likely was due to "progressive rodent cardiomyopathy", a syndrome commonly observed in this strain of rats.


•The FDA requested that the Company perform an additional study in which rats are to be given a single administration of three dosages of CX1739, followed by neuro-histopathology evaluation 1, 3 and 14 days after drug administration. In two previous studies, no neuropathology had been observed after 14 or 28 days of CX1739 administration at very high doses. The agreed upon single dose study has begun and is scheduled to be completed by year end.

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