RespireRx Pharmaceuticals Inc (RSPI)

[food4thought]

I found this rant posted by "valiumgirl4" over at the YAHOO board, I found it to be a bit compelling...any comments? It might create some discussion here being that there appears to be a lack of one.

>>Roger's milestones are all based on his need to have a plan where they'll be able to accomplish something before they run out of money.

How the heck can he start Phase 1 for RD if they're not sure what type of drug overdose they want to target? Davidal said he has no room for the inevitable "slippage." Well, that is certainly true. So consider the FACT that Phase 1 trials in humans can only commence after the FDA *accepts* the IND application. And we all know how well Mr. Roger did with ADHD. With the FDA letter lost in the mail, Roger is too meek to ask them to fax or FedEx it to him. So what are the odds he'll do any better with RD?

Is the absence of Shire a factor?

Here we are in Q4 and Roger wants to give some money to some Brits to test CX-717 on humans for RD to see if it works in humans like it worked with rats. Someone needs to tell Roger that he needs to be able to talk to the FDA if he wants to file more INDs. If he's too timid to ask them to resend that letter to him, he won't make any headway whatsoever. Although some think the drug approval process is akin to winning at a slot machine, http://www.newstarget.com/019987.html , it's much more complicated. Here is a brief synopsis: http://www.fdareview.org/approval_proces...

The first step towards getting FDA approval is the filing of the IND application, which is described here:
http://www.fda.gov/cder/regulatory/appli...

Reading about the inept doings here reminds me of Alice in Wonderland. Propofol ?!?!??????

Ask any doctor or nurse and they'll tell you that the clearly predominant cause of treatable respiratory depression is the result of opioids, either inadvertent to prudent medical treatment or the result of intentional or accidental overdose.

So now propofol is on a list of ten? Sheesh! Don't hold your breath! Pun unintentional.

Here. Just read these articles from several places reprting succes with at least two commonly available dopamine (D1) agonists (e.g. forskolin: http://en.wikipedia.org/wiki/Forskolin , available to anyone here http://bodybuilding.com/store/fors.html ) in cats as an alternative to the current standard practice of using mu antagonists like naloxone.

http://www.pubmedcentral.nih.gov/article...
http://ajpregu.physiology.org/cgi/conten...
http://ajpregu.physiology.org/cgi/reprin...

If someone is turning blue from opioid OD, naloxone will get them breathing but they'll be in distress from withdrawals, or abstinence syndrome. Using the mixed agonist-antagonist nalbuphine was reported as being largely successful here, with the advantage over naloxone of preserving some measure of pain relief (antinociception):
http://www.cja-jca.org/cgi/reprint/37/7/...

Anyway, someone ought to tell Mr. Roger that dopamine agonists are further along than his dream of using ampakines. CX-717 reversed RD in rats. Yawn.

Don't think that just because RD is (usually) an acute indication that the histpathology results that killed CX-717 at Psychiatry won't be resurrected. Why would FDA allow a "brain tissue destroying" drug to be used for an indication where doctors are perfectly happy to give the patients naloxone. So what if the patient is uncomfortable? Does anyone with a brain really think that this drug has a chance of replacing naloxone for RD?

Look at these articles and then do some Googleing on
keywords.<<




This is her response to a contrary opion of her statement above:




>>Oh, really?

What kind of experimental design for for RD could they use in humans which would get approval from an IRB?

If you bothered to read the studies about dopamine used to stimulat cAMP, the highest mammal they have used so far for these studies is the cat. The D(sub)1/cAMP approach would have been tried in monkeys by now if they figured out a way to make it an ethical experiment for primates. DARPA could easily afford to do primate studies.

There have not been any studies with primates to corroborate the fentanyl OD results obtained with cats in both U.S. and Germany (provided).

There is no clinical trial in the U.K. recruiting RD subjects. Rogers has been mistakenly thinking they have to winnow out one indication from ten he's dreamed up. That itself indicates he is lying about their progress.

Here we are in November and Rogers hasn't figured out the fentanyl is the drug they need to use to induce RD so that they can see if it can be reversed with an ampakine.

Without knowing the OD drug, it would be impossible to design an experiment. Without a design, they can't submit it for approval. They need to have it all approved by both FDA and an FDA-recognized IRB if they want the study results to count towards a future NDA application. That takes months.

How could SAFELY induce (and reverse) the RD in these Phase 1 "healthy (but poor) volunteers"? And is this U.K. trial listed at clinicaltrials.gov? No? Oh, how convenient, it's not in U.S. Can you find it on a U.K. website? Can you find a CRO trying to recruit the subjects?

One of the stocks i follow is PTIE. They have a similar situation involving an opioid clinical trial for their Oxytrex. Almost a year ago they announced what they called the "Extreme Study" Mr. Barbier (CEO) keeps telling investors that the study is proceeding slower than expected because of the difficulty in recruiting human subjects who suffer chronic pain and are dependent on oxycodone who are willing to endure the "torture" of medically supervised rapid detox using high doses of naloxone to trigger full withdrawals for an hour or two while hooked up to machines to monitor their vitals with people standing by to catch their vomit and diarrhea so the quantities can be measured.

How much money would you want if a CRO wanted to recruit you for a P1 study where RD would be induced ... and hopefully successfully reversed before you suffered brain damage?

If they're so sure they're doing P1 on humans in Q1, they would have already had their design finalized, which means that propofol would not have been mentioned. The design can't be finalized unless all the details are worked out and approved by an IRB. If Rogers mistakenly believes that he has to pick from ten different possible types of RD causes, he's a buffoon, because if he spent five minutes with Google he'd learn that opioids are at the top of the list, with no second contender outside of anesthetic agents administered during surgery with all the life support equipment and personnel available in operating rooms.

As far as your confidence that these studies WILL begin in the U.K. in Q1, what evidence do you have for that apart from the same "letter is in the mail, but i'm afraid to ask them to fax it" Mr. Rogers? <<


There cetainly appear to valid points here, particularly pertaining to the RD study and timeline.