Cortex owns the license and the patents on Dronabinol

I think the NIH study goes directly to Carney and is multiyear.

Wonder why he quit?

1. To save money (?)
2. In prep for sale of company?
3. He has better things to do - left with the NIH contract
4. Lawsuit due to noncompliance with SEC - he doesn't want liability.
5. Varney has bad breath.

PS What is Samyang's interest. And Illinois Ventures? They still own this POS.

Maximalexander

IMHO the rights to be licensed are secondary or even tertiary -- meaning that they are giving up very little. Given the time and money needed, even if CX... whatever gets to the stage to treat neurodegenerative diseases, the big markets (Europe, US/Can and Japan) will account for the predominant share of revs. CORX is in a race against time and financial resources, the faster it can gain any credibility that might some day be monetized the better. I would applaud any deal with Samyang.

MOUs in general have no legal standing. They are indications of mutual intentions to work together, nothing more. Maximalexander

I cannot see how this MOU is anything but positive and in conjunction with the Servier early (not last minute) decision to move forward on its licensing, this may begin showing a pattern should there be another even small deal which would generate more interest and perhaps a better valuation.

Perhaps this was Plan B if Servier didn't bite and they couldn't cancel once they started.

No. $499,000 for shares and warrants.

Must have come to the conclusion that it is NOT throwing good after bad. Perhaps will this help fund new IND?

Was this a backup in case Servier didn't follow through? Did CORX need the $$$?

Also saw this EZine entry Oct 24 Improving overall cognitive capability is becoming as simple as consuming a pill
...."The potential for improving memory, concentration and other important cognitive skills has been initially observed by pharmaceutical companies and military research. Nowadays, most large drug producers in the world are on their way to test Ampakines, and other ‘cognitive enhancing’ drug types. The military has performed several trials and it is particularly interested in the alertness effects of Ampakines, such as CX717 (developed by Cortex Pharmaceuticals). " I though this was old news.

According to the filing, they are still analyzing the results of the sleep apnea fiasco. It says that in about five places "STILL ANALYZING THE RESULTS!"

Maybe they kept losing consciousness when they saw what the results were - or are they stalling because results are bad -- or are they playing it close to vest because ... oh I'm dreaming too now.

Maximalexander

I met Jerry Brown when he was running for President 30 years ago.

This was after he gave a speech on the dangers of "desertification" but a portion of the audience looked a bit mystified as to what this new global danger was all about.

Definition: An index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. These pauses in breathing must last for 10 seconds and are associated with a decrease in oxygenation of the blood. In general, the AHI can be used to classify the severity of disease (mild 5-15, moderate 15-30, and severe greater than 30).
Also Known As: Apnea-Hypopnea Index, Respiratory Disturbance Index or RDI
Examples: My AHI was quite elevated, but it has greatly improved with treatment.

From March 15th on British Snoring site. Seems that at that time they were still looking for six to complete the study. CX717 given in capsule form (see below). Kind of interesting from a volunteer's perspective. He noted his AHI in this blinded study did drop.


March 15
Fellow OSA suffers, I have been asked by another member to post something on the site about the Quintiles drug trial, as one of the few posters that have actually gone through it.

Firstly, I was not attracted by any agency, I went to Quintiles direct. I would also point out that the safety of the drug people get dosed with has already been tested on health volunteers and this is a second stage trial.

I will try and describe day by day what the trial consists of and my feeling as it went on (from memory)

I went in on a Monday lunchtime and had a basic screening, heart, blood pressure and bloods for drugs and other nasty things such as HIV and the like and they give you a full neurological scan.

Then they tell you if you pass the first bit of the screening, if you go straight through they give you a bed for the night and do the first overnight screening, in all honesty I can not remember what the AHI had to be but mine had gone up to 50 (from 48) and they said I was well inside .

The next day if the results of the first day and nights test are OK you are admitted properly for the trial. Other than that not much else happens on that day or night.

On the Wednesday you have the overnight screening again and if it varies (if I remember correctly) more than 40% from the first nights results you are excluded from the rest of the trial.

On the Thursday night I was dosed and was hooked up for the night again. I do know that my AHI did drop on the Thursday whether I was dosed or not. On the Friday I got off home just after lunch.

During the time they do give you a few heart traces, blood tests and BP but they are really good at them and I could not really say they caused any discomfort.

You then go back for a follow up a week or so after for some more blood tests and are you OK questions.

The staff are pretty good on the whole, but the very occasional one, I felt did treat you a little bit like you are there for the money. That is understandable when most of the people there are healthy and are only there for the money.

I think when I did the trail there had been 80 or so healthy volunteers to ensure the drug was safe and then about 12 with OSA.

I understand they are still looking for 6 volunteers to complete this phase of the study. The person to talk to for the details is Ibraheem Essack at Quintiles 0207-910-7912. Please feel free you say Phil from Shropshire suggested you contact him. He is a nice guy and will guide you through the entire process as well as being the team Neurophysiologist.

The only suggestion I would make if you decide to go for the trail is to make sure you take something to do because there are long spells of doing nothing.

As I said at the start this post is just to provide information to anyone who may be considering the trial and not to start a debate over the rights and wrongs.


Last edited by SleeplessinSalop on Wed Mar 17, 2010 5:15 pm, edited 1 time in total.




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Sleep2Snore Post subject: Re: Quintiles Drug TrialPosted: Mon Mar 15, 2010 11:41 pm


Colonel Snorer

Joined: Tue Oct 14, 2008 10:20 pm
Posts: 303 I suppose you will never know if you got the drug or the control.

Was the drug tablet form or liquid, just out of interest?

It is way to far for me to travel anyway even if I did want to.





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SleeplessinSalop Post subject: Re: Quintiles Drug TrialPosted: Wed Mar 17, 2010 12:50 am


Warrant Officer Snorer

Joined: Tue Oct 06, 2009 9:22 am
Posts: 59 Hi it was several capsules

I believe you are correct. I don't think they would be pursuing this with the cost in time and resources to the company which was running on fumes unless they had more than an inkling that the data will strongly hint at POC. Stock should jump when data is released (unless they are wrong - certainly a possibility but I think unlikely). Depending upon results jump may be weak or very big - just added 10K @

Maximalexander

UPDATE from SA Trial posted APr 18

from Britishsnoring site forum

equiton Post subject: Re: Sleep Apnoea Drug Trial - Paid Volunteers NeededPosted: Sun Apr 18, 2010 1:53 pm


Private Snorer

Joined: Mon Feb 15, 2010 1:34 am
Posts: 3 For those who are interested,
I went to Quintiles last week and had the screening for the trial. That was a day of tests and an overnight stay. I failed on one of the blood tests and they are now rechecking the results, so did not stay for the duration which would have been a further 4 days and 3 nights.. It was well worth going to get the thorough testing and to help with what may be an important treatment for OSA. As an example the NHS had my AHI measured at 7 using the finger device which kept falling of all night and have treated me has somebody with mild OSA. The full polysomnograph test which Quintiles used measured an AHI of 34. That information alone was worth the trip.
Its not 5 star accommodation, the food is dreadful but with a laptop full of video's, work I can catch up on,internet access, a couple of books etc I will cheerfully go back. The staff are very competent, good humoured and easy to get on with and they compensate you financially for being there.
I would recommend anybody who is interested to go.

tony

This is one of you funnier posts. :>)

Maxim

ok for the web site go to

www.trialreach.com

search on "sleep Apnea" and CX-1739 is one of the first that comes up.

Good luck.

Hope they are near the end?!!@#$&*()%^

SA Study

TrialReach.com has a much-improved website and information.
It is a new UK company currently listing info on 85,000 trials.

For the CX 1739 trial go to insert-text-here
OF INTEREST, under the question


16. Has CX1739 been given to people before?
Yes, CX1739 has been given to around over 90 people to date. The Informed Consent Form contains information about potential side effects or risks of taking part.

Thanks Haysaw (and GEnisi)

The film has and should get bad reviews.

However, it was interesting to me to show the commercial, regulatory, personality, power and other constraints and opportunities that buffet drug science as it moves from a brilliant researcher throught the commercialization process.

THe fact that they could initially only get VC funding by giving them "a deal they couldn't possibly refuse" speak volumes. And then the VC pulled the plug and forced them to sell the company after only 6 months. The researcher and the business promoter (who has the 2 kids suffering from the orphan disease) both got rich but then the rules, culture, and everything else changes. The genius researcher's idiosyncratic ways make him an outcast, the business manager only was taken on by the acquirer because it was forced to. The "mother of all experiments" exudes a culture of competition versus collaboration. In the end, practicality takes precedence over truth - the drug chosen is one easier to develop and cruder and not as effective, but the other may never work - too many variables, more time and more cost.

For these reasons alone I would recommend the movie. And Harrison Ford - the only saving grace.

Hi GFP:

YOu may be right about 10 completers, but that cannot be inferred from what Julie at Trial Reach says. When she says there are only 10 places left, she is referring to the following statement made at the Trial Reach Link for the Cortex trial:

"This clinical trial is divided into five parts, involving a total of 116 volunteers. To date, over 96 volunteers have already taken part in the study."

So the 10 places left is 116 minu 96.

Trial Reach appears to be a web venture that may be profit driven or not but in any case provides some information, but it may be confused. Who knows. I guess one could email her.

Maximalexander

I defer to you on this.

But I do not believe near bankruptcy had any impact on delaying. i think there was active and still is active recruitment, $$$ or not. I'm not sure if Quintiles worked generating a account receivable or they prefunded or Quintiles has to swallow a loss due to design -- this is just my gut feeling.

It makes sense to me that they would change the eligibility criteria because they were overly strict and couldn't get 10 eligibles after a couple of hundred, but compensated by quintupling the N from 20 to 100.

It is just a likely that they Neuro is correct and N still equals 20. But with loosened eligibility I cant see why they are still working on this in January?

Max

Obviously if there are only 20 in the study, there is some confusion in this poster's understanding [julie@trialreach.com] although she seems to be more knowledgeable about the specifics than most here since she put up the information on the Trial Reach website. Please see the following excerpt from the "TrialReach" poster on the BritishSnoring website message board [Message date Saturday December 5]:


"4. Let me clarify something else for you: 'Only' 96 people have taken part in the trial - BUT HUNDREDS MORE HAVE APPLIED (AND DIDN'T MEET THE CRITERIA). And there are about only 10 places left before the study completes the enrollment!


If anyone is interested in learning more about this or other trials, without having to be harassed by those not interested, you can visit trialreach.com or contact me on julie at trialreach.com.

Thanks to all for your time and attention,

Julie"
Patient Liaison Manager
TrialReach.com

I give up:

You must cut and paste yourselves

https://www.trialreach.com/cortex/html/view_study.php

Let me try that again:

insert-text-here

insert-text-here

From Trialreach.com

]This clinical trial is divided into five parts, involving a total of 116 volunteers. To date, over 96 volunteers have already taken part in the study.

Looks like they expanded the trial from 20 -- I think that is good news. Maximalexander

What is this clinical trial about?
This is a study to test the safety, tolerability and effects of a new drug (called CX1739) on both healthy volunteers and patients suffering from sleep apnoea. The purpose of this part of the study is to examine the potential of a single dose of CX1739 to improve sleep in male patients and female patients of non-child-bearing potential with sleep apnoea. This will be determined by the effect of CX1739 on night time sleep as recorded by polysomnography (PSG) which involves sticking recording electrodes on the head and is not painful. During PSG recordings the pattern of your sleep is recorded (with respect to your brain wave activity, muscle activity, eye movement, breathing rate and heart rhythm).
Who is carrying out this clinical trial?
The organisation conducting this clinical trial is Quintiles Drug Research Unit at Guy’s Hospital, a division of Quintiles Ltd. Quintiles Drug Research Unit at Guy’s Hospital is a leading medical research company with over 25 years of experience in this type of trial. The study is funded by the company which has developed the new drug, Cortex Pharmaceuticals Inc.
Who can participate in this study?
This study is for people who live in the UK, are between 18 and 64 years of age, have been diagnosed with sleep apnoea, and are otherwise considered in good health. For more details about eligibility, click here.
How many people are participating in the study?
This clinical trial is divided into five parts, involving a total of 116 volunteers. To date, over 96 volunteers have already taken part in the study.

Extraordinary Measures

Just saw the pre-show of this film (brendan frazer, harrison ford) about how a U of Nebraska (in the movie - U of OK in real life) scientist and Harvard MBA started a company to cure Pompe disease (which the MBA's two kids are dying from).

While I think it should go quickly to video, it is interesting to see the challenges (based on a real story) facing a small biotech firm. They finally get funding from a VC (after living off of charitable donations) but promise clinical trials within a year. When they can't perform they sell out after 6 months and both become rich and work for the acquirer.

The most relevant parts are Harrison Ford (scientist) having show downs with the VC and acquirer who prod him with reality of how to get past FDA and other hurdles and the need for quick commercialization. Then at the acquirer, the way the scientists work not collaboratively but in 4 competitive teams. Politics, ethics, greed, personality, ego and the rest ...

In the end, they have a usable enzyme for trials but stick to the low risk high probability of efficacy population of infants, leaving Mr. MBA's kids out in the cold. Finally he gets them in a sibling study but this requires him to lose his job due to conflict of interest.

Makes me think a lot about applicabiltiy to this long-suffering company.

finally another trade - now 13 cents.

Any chance of a partnership that includes an investment in new equity? Perhaps that was part of the reason - much better than a Pipe and provides upside to the partner (win/win)

It would have been nice to have had a rights offering -- I am sure that they could raise a couple of months easily - but they take some time and are too complicated for the likes of Cortex (I guess)

Drips and drabs and little push down to 15 cent close.

Now that's more like it.

Why doesn't management give up their pay for December? Just pretend their unemployed for a month - and pay themselves in stock instead?

Moreover, if the company is headed towards bankruptcy or a downward spiral of financing, then most of management is unnecessary and the CEO' (and chairman's) job is to make decisions to reflect that.

Have a good weekend. [Unless the PIPE comes afterhours]

MaximALEXANDER

Just an extra couple of clicks - thanks for the lead.

I have got to say I am surprised that even though the price drops when someone unloads a small bundle, it bounces back?

Who is buying? And why when it looks like there is going to be a dilutive pipe any day? Easy to manipulate with such a small float and low SP, but I would think someone would be manipulating it down, since the company/officers are restricted in supporting the price through trades.

Maximalexander

Please Santa - all I want for Christmas is my Ampankines.

From the website:

"This clinical trial is divided into five parts, involving a total of 116 volunteers. To date, over 96 volunteers have already taken part in the study. "

I wonder if this is old data -- thought number was closer to 200.

I think that with many posters we are merely seeing human nature at work as certain external "facts" such as share price cause huge cognitive dissonance (i.e., don't jive) with their earlier view of reality (i.e., Cortex is very valuable "to da moon") and they vaccilated until now they are disgusted and frustrated by the dissonance.

The result: anger at management,themselves and the unfairness.

The result: a re-evaluation that now Cortex is worthless. Now its compounds must pass a much higher standard than other Biotech compunds to have any value (and more than 5 cents for the company).

This is human irrationality in action.

I am no exception. Difference is I don't post as often but suffer silently and hoping. My hope is partly based in the fact that if I was so wrong before, maybe the selling at 15 cents would also be so wrong now.

Oh well - when one is brought to the low level of humbleness by events (and a huge proportion of my and other's money lost) one looks to the real values in the present moment in life. Especially at this special time of year (Christmas) whose message is everlasting hope.

MaximAlexander

I would think that Cor's patent estate would be worth many multiples of Cor's current market value. And it would cost many more multiples to reproduce it.

That being said, they have wormed themselves into a tight spot. The natural foil to this would be to get some bidding competition. And some strategy that shows potential bidders and suiters that if they try to low ball and delay too much they will end up with nothing -- because they will sell to someone else (If they sold the company, the bidder would have to start afresh at much higher prices, most likely) or they would somehow ensure that nobody gets it - go virtual and take it off the market.

Its all so tiresome. Max

Over 200,000 shares in first hour and price is up to --woo hoo -- 16 cents. No big shakes -but why when they will be out of cash in 2 weeks according to GPF? Should be sub 10 cents (or at least be heading down or no volume)

Thoughts?

Maximalexander

I hope there was not some nefarious intent. For instance, give Cortex the impression that they would get their upfront in a timely fashion so that the buyer would have more leverage when the deadline came and went and the coffers at Cortex were that much lower. Sheer speculation.

Thanks Horselover:

My reading of your words is that they hold the glimmer of hope.

Apparently there is a deal whose terms were acceptable but where the other party started to play games and may still pull the trigger (with encouragement and at the possible expense of more dilution).

Not great or even good, but better than some may have seen in their dark imaginings.

Maximalexander

They took the advertisement for paid volunteers off the BritishSnoring.com site for whatever reason.

There were only two of 24 messages in the site forum related to the request for volunteer for the Quintiles study that seemed relevant. 1) someone wrote in that their son had seen similar ads for volunteers at local universities and 2) the following message that shows at least one person was going through the study in October:

Post subject: Re: Sleep Apnoea Drug Trial - Paid Volunteers NeededPosted: Sun Oct 25, 2009 9:22 pm

Daffydd is still there having treatment

Colonel Snorer

So at least one new patient was undergoing the study in late October.


Joined: Sun Sep 28, 2008 5:19 pm
Posts: 447
Location: Worcester (UK) Daffydd is still there having treatment

People only average down if they are suckers (like me)
or if they really believe that the company will have an higher market value per share than 15 cents in the forseable future.

I just wonder why the company is valued at $8 million? and if it will eventually be worth less (worthless). But then again that is what everyone is asking - how could it be mishandled so poorly. Or do we only see the appearance and the submerged tip of the iceberg will show more reliazable value.

Maximalexander

They have a biotech practice and were instrumental in the Therox $100 million IPO. They also have corporate governance.

Could be a winding up, Could be to execute a deal, Could be ...

The ad itself was free. A courtesy of the website.

I wonder what the contract was with Quintiles - which party held the risk of nonrecruitment, Cortex or Quintiles. Probably some complicated formula since Quintiles was the expert and presumably had control in how to recruit, but can't/won't take the risk of not getting enough eligibles.

Still even if it were all on Cortex, how much do these things cost?

"WSJ"

The Wall Street Transcript is not WSJ. It is a micro cap for-profit entity that interviews very tiny companies and sponsors forums. Reaches a select audience that invests in these cos.

The question I have, is why pull the ad at all?

They pulled it, then put it back on.

Perhaps they thought they had enough volunteers, or the Snoring site didn't wan't it on anymore (unlikely IMO), or they weren't getting any volunteers (which I think is the case).

So why put it back on, now? If they did a partial unblind and saw promising results? If they don't have enough but feel confidant of survival and want to finish and "do it up right" even if means several more months?

And what is Quintiles role in all this. I hear they also were soliciting at British Universities near London.

Maximalexander