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Cortex Pharmaceuticals (CORX)

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Last Post: 10/2/2015 8:53:16 PM - Followers: 155 - Board type: Free - Posts Today: 0

Note - Ongoing and planned clinical activities are highlighted in Yellow -

Cortex Pharmaceuticals,
Inc. is a biopharmaceutical company focused on the discovery and development of novel therapies for the treatment of Sleep Apnea, drug-induced Respiratory Depression, and other brain mediated breathing disorders.  In August 2012, Cortex merged with privately held Pier Pharmaceuticals in an all stock transaction, with Pier becoming a wholly-owned subsidiary of Cortex -

Cortex website -

Dronabinol -  Targeting Obstructive Sleep Apnea.  

--- Ongoing Phase 2b in Obstructive Sleep Apnea, 120 subjects, dosing 2.5 mg and 10 mg qd for 6 weeks, placebo controlled, topline data due Q4-15, fully funded $5 mil by NIH grant

This program was acquired in the Pier Pharma merger.

Phase 2b enrollment began Dec 2012, with full funding from the NIH (approx $5 mil in NIH funding).  The trial will enroll 120 patients, using two doses of Dronabinol -- a 2.5 mg arm dosing for 6 weeks and a 10 mg arm dosing for 4 weeks after a 2 week dose escalation.  These are similar dosing levels to those that Dronabinol already has FDA approval for in CINV and AIDS anorexia.  Patients will receive Dronabinol 1 hour prior to bedtime. Estimated completion date is May 2015  

Dr. Carley (Professor at the Univ of Illinois, and former Chief Science Officer at Pier Pharma) is the principal investigator. Enrollment began Dec 2012 at the Univ of Illinois, and Northwestern Univ will also be participating.

Dronabinol is a synthetic derivative of the naturally occurring substance in the cannabis plant, namely delta-9-tetrahydrocannabinol, otherwise known as delta-9 THC. Dronabinol is one of many derivatives found in the cannabis plant which includes other compounds as well such as cannabidiol (CBD) and cannabichromene (CBC), to name a few.

Dronabinol is currently FDA approved for use in refractory chemotherapy-induced nausea and vomiting (CINV) as well as for anorexia associated with weight loss in patients with AIDS.  Its use in these two indications is at a dose range of 2.5 mg to 10 mg twices daily.    Cortex acquired the Dronabinol program in its merger with Pier Pharma in Aug 2012, and Dronabinol is being evaluated to see whether a low dose Dronabinol therapy used in a proprietary formulation given daily at bedtime will significantly improve the apnea-hypopnea index (AHI) as well as other subjective and objective measures of clinical improvement in patients with OSA.


Dronabinol is an orally active cannabinoid which, like other cannabinoids, has complex effects on the central nervous system (CNS), including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol and other cannabinoids.
The mechanism of action of dronabinol's benefit in OSA is thought to be complex but related to the following dynamics outlined below and in the graphic representation that follows:
  • Peripheral CB1 receptor activation directly inhibits the afferent vagus nerve, and indirectly closes 5-HT3 ion channels (peripheral 5-HT induces apnea, via 5-HT3 receptors), leading to a reduced negative feedback loop on upper airway motor (UAM) tone and activity
    In the CNS, decreased serotonin (central 5-HT excitatory to motor neurons and prevents apnea) and noradrenaline levels during sleep ↓upper airway motor outputs.
    Central CB1 receptor activation results in an ↑ in brainstem monoamine levels, including serotonin (5-HT) and noradrenaline (NA), leading to ↑ upper airway muscle tone & activity.

Dronabinol Phase 2a results in Obstructive Sleep Apnea -

(This data was presented at the May 2011 meeting of the American Thoracic Society) -

The Phase 2a enrolled 22 patients, dosed for 21 days, with doses escalating from 2.5 mg to 5 mg to 10 mg.  A single dose was given 30 minutes before bedtime.   Statistical improvement in the primary endpoint (AHI -- Apnea-Hypopnea Index) was seen at the 2.5 and 10 mg dose levels, with a reduction in the AHI index score in the moderate-severe sleep apnea patients of approx 30%.  Dronabinol was safe and well-tolerated, with no degradation of sleep architecture. 


AMPAKINES - Allosteric upmodulators of the AMPA receptor
Ampakines are allosteric, meaning they amplify existing neural signals, rather than creating brand new neural signals as an agonist compound does.  Low Impact type Ampakines upregulate AMPA activity without producing significant BDNF upregulation, while High Impact Ampakines also upregulate production of BDNF and other neural growth factors.   Low and High Impacts bind at different binding sites on the AMPA receptor.  Low impacts are inherently much less prone to inducing excitotoxicity/seizures than high impacts.   In fact, low impacts like CX-717 and CX-1739 are so safe that it wasn't really possible to generate a true MTD - Max Tolerated Dose in Phase 1.         

 Low Impact Ampakines -

CX-1739 - Approx 3 times more potent than CX-717, halflife 7.2 hours, patent to 2028

Phase 2a completed in Sleep Apnea, with extremely strong results seen in Central type Sleep Apnea, and good activity also seen in Mixed type Sleep Apnea.   CX-1739 can also target ADHD, the cognitive aspects of Schizophrenia, Depression, and all other indications suitable for a low impact Ampakine (ie - where BDNF upregulation isn't a requirement).  CX-1739 is completely free from the preclinical 'artifact' histological phenomenon  that derailed development of CX-717 - 

Sleep Apnea Phase 2a results (CX-1739) -


CX-1942 - Water soluble prodrug of CX-1763 for intravenous use, targeting Respiratory Depression, approx 5 times more potent than CX-717 in animal models of RD.  Final preclinical studies starting Q3-14 and completing Q2-15.

CX-1763 - Low impact compound, preclinical, the oral version of CX-1942

CX-2076 - Low impact compound, preclinical

CX-717 -

Phase 2a completed in Respiratory Depression in which CX-717 demonstrated Ampakine's ability to both prevent and reverse opioid induced Respiratory Depression without diminishing the pain relieving properties of the opioid.   Ampakines have also demonstrated preclinically the ability to reverse barbiturate induced Respiratory Depression (Propofol), a clinical area without any current treatments (naloxone/Narcan does not work on barbiturates).   CX-717 also completed a Phase 2a  in ADHD  and showed statistically significant efficacy in both primary endpoints - the hyperactivity and the inattentiveness subscales.  Unlike current stimulant type ADHD drugs, Ampakines do not increase heart rate or blood pressure.  CX-717 also showed good efficacy in reversing the cognitive effects of Sleep Deprivation (UK study) -

Respiratory Depression Phase 2a results (CX-717) -

ADHD Phase 2a results (CX-717) -

Sleep Deprivation Phase 2a results (CX-717) (UK study) -


High Impact Ampakines - (upregulate BDNF)
With the ability to upregulate BDNF and other brain growth factors, high impact Ampakines may have the potential to slow, halt, or even reverse many neurodegenerative diseases.    Cortex's high impacts (Benzamide related) are different chemical families than the high impacts of other companies like Lilly, Glaxo, and Merck (Biarylpropylsulfonamides, Benzothiazides, etc).  In the 2008-2010 period, Cortex also developed and patented multiple new families of improved high impacts which are awaiting funding/partnership.     

CX-1632 - (S-47445) - Phase 1 completed, targeting Alzheimer's (Servier)

CX-1846 - Lead in-house high impact, awaiting IND enabling studies, possibly targeting Parkinson's

CX-1837 - High impact 


Key Press Releases -


July 1, 2014 - Cortex enters into a new licensing agreement with Univ of Illinois for use of cannabinoids in the treatment of Sleep Related Breathing Disorders -

Aug 14, 2012 - Cortex announces merger with Pier Pharmaceuticals in an all stock transaction -
Oct 6, 2011 -- Servier Exercises Option to Cortex's Ampakine CX1632, an Innovative Compound in Clinical Development for Alzheimer's Disease  --
Aug 24, 2011 -- Cortex Receives U.S. Patent for the use of Ampakine Molecules to Treat Respiratory Depression --
Apr 26, 2011 -- Cortex Receives Granted US Patent for its Lead AMPAKINE® Molecule CX-1739
Mar 16, 2011 -- Cortex Reacquires all Ampakine Compounds, Related Patents and Exclusive Global Rights for Respiratory Depression from Biovail  --
Feb 2, 2011 -- CX-1739 Improves Respiratory Parameters In Obstructive Sleep Apnea Patients --
Jul 6, 2010 - Funding from The Michael J. Fox Foundation to discover drug candidates for Parkinson's disease --
Aug, 2008 - Cortex's AMPAKINE Molecule CX717 Has Positive Effects in Opiate-Induced Respiratory Depression in a Phase IIa Clinical Study -
Q1-2006 - ADHD Phase 2a results (CX-717) -


Ampakines have the potential to address indications that range from orphan indications to $1 Billion plus sized markets -

Respiratory -

Opioid Induced Respiratory Depression -

--- Positive Phase 2a data with CX-717

--- Phase 2a with CX-1739 planned to start Q1-15 and complete Q3-15

Barbiturate Induced Respiratory Depression -

--- Phase 2a with CX-1739 planned using Propofol to start Q2-15 and complete Q4-15

Sleep Apnea (especially Central type SA) ---- (positive Phase 2a data with CX-1739)

Respiratory aspects of Sickle Cell Crisis

Neuro / Psych -

Low Impact Ampakines -
ADHD -------------------------------------------------------(positive Phase 2a data with CX-717)

Cognitive aspects of Alzheimer's Disease
Cognitive aspects of Schizophrenia
Cognitive aspects of Parkinson's
Cognitive aspects of Sleep Deprivation ----------(positive Phase 2a data with CX-717 - UK study)
MCI (Mild Cognitive Impairment)
Memory Loss due to ECT (Electroconvulsive therapy)
Memory Loss due to CABGS (Coronary Artery Bypass Graft Surgery)
EDS (Excessive Daytime Sleepiness)

High Impact Ampakines - (disease modifying via BDNF upregulation)
Alzheimers Disease
Parkinson's Disease
Huntington's Disease
ALS (Amyotrophic Lateral Sclerosis)
Rett's Syndrome
Angelman Syndrome
Fragile X
SCI (Spinal Cord Injury)
TBI (Traumatic Brain Injury)

Cortex company website:

Dr. Tracy (NI Research / NeuroPerspective) Cortex commentary:

Patent database : Ampa related patents -

Information website for Ampakines (not an official Cortex company website):

Research Paper abstracts for "Ampakines":

Yahoo Cortex Message Board:

Silicon Investor Cortex Message Board:

SEC Filings -

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Current Price
Bid Ask Day's Range
CORX News: Current Report Filing (8-k) 10/02/2015 05:18:00 PM
CORX News: Small Company Offering and Sale of Securities Without Registration (d) 09/11/2015 12:31:43 PM
CORX News: Current Report Filing (8-k) 09/08/2015 04:48:36 PM
CORX News: Statement of Changes in Beneficial Ownership (4) 08/31/2015 04:23:09 PM
CORX News: Current Report Filing (8-k) 08/31/2015 08:46:24 AM
#39365   Didn't the CEO just say non dilutive financing?! Joey Rosa 10/02/15 08:53:16 PM
#39364   Seems like whenever CORX closes down on strong drfreely 10/01/15 12:24:57 PM
#39363   460k sale today..that's a lot at these low levels Joey Rosa 09/29/15 06:18:36 PM
#39362   Right now I also see corx NOT being drfreely 09/28/15 07:01:18 PM
#39361   Bottom line, the new management has the ship bridgrace 09/23/15 02:11:50 PM
#39360   "the delay in the sleep apnea trial (due Cincinnatus 09/16/15 10:11:04 AM
#39359   Thanks much, Gfp. Things are going to get bridgrace 09/16/15 08:55:54 AM
#39358   Bridgrace, The Form D is for the gfp927z 09/16/15 01:41:24 AM
#39357   Gfp, Can you explain the latest SEC filing? Thanks. bridgrace 09/15/15 01:48:17 PM
#39356   Two thumbs up Gfp. Certainly some positives and food4thought 09/10/15 06:36:33 PM
#39355   Nice presentation. In addition to the ongoing gfp927z 09/10/15 05:50:59 PM
#39354   R+R presentation webcast today at 4:40 EST - gfp927z 09/10/15 11:58:48 AM
#39353   Looks like CORX will be presenting at the BollixMeArse 09/03/15 11:50:16 AM
#39352   Re: Manuso. drfreely 08/31/15 12:15:41 PM
#39351   So looks like CX-1739 will be back in gfp927z 08/31/15 10:28:48 AM
#39350   >>> Cortex Pharmaceuticals, Inc. Announces Initial Closing of gfp927z 08/31/15 09:10:33 AM
#39349   $CORX stepping in..we'll see. So far so good. MrK 08/25/15 12:52:29 AM
#39348   Of course I did, I was buying more Joey Rosa 08/24/15 05:28:17 PM
#39347   You called the bottom dude! Hope you took drfreely 08/24/15 03:59:07 PM
#39346   LOOMING 1 , 4 0 0, in2it 08/24/15 02:11:17 PM
#39345   Good stuff BCN. MrK 08/21/15 05:21:42 PM
#39344   Which I believe will happen. $CORX had 9 BCNstocks 08/21/15 05:00:49 PM
#39343   I agree...will be looking into $CORX closer MrK 08/21/15 04:21:45 PM
#39342   MrK, As a TA/bottom play the Cortex gfp927z 08/21/15 04:19:35 PM
#39341   $CORX will need more volume IMO...we'll see. MrK 08/21/15 03:44:02 PM
#39340   I rarely look into or listen to the MrK 08/21/15 03:42:59 PM
#39339   MrK, Though the stock has been cursed gfp927z 08/21/15 03:38:32 PM
#39338   $CORX chart...looks great MrK 08/21/15 02:25:50 PM
#39337   This big news has, as of 1:15 p.m. subuclayton 08/21/15 02:19:34 PM
#39336   Lone Wolf, >> notes converts to warrants gfp927z 08/21/15 01:55:20 PM
#39335   Wow, this is big news. I remember gfp927z 08/21/15 01:49:24 PM
#39334   Details from the 8-K - gfp927z 08/21/15 01:29:29 PM
#39333   Full press release -- >>> Cortex Pharmaceuticals, Inc. gfp927z 08/21/15 01:26:30 PM
#39332   $CORX Liking this one MrK 08/21/15 01:23:45 PM
#39331   Looks like he has the connections to see Lone Wolf 08/20/15 08:18:31 PM
#39330   I don't know him. But he has a neuroinv 08/19/15 10:38:23 PM
#39329   Neuro, What do you know/think of the new CEO? TIA. bridgrace 08/19/15 05:58:06 PM
#39328   New CEO appointed: Dogleg9 08/19/15 11:26:12 AM
#39327   100% Joey Rosa 08/17/15 11:03:23 PM
#39326   Thanks so much, Neuro. We'd appreciate you weighing bridgrace 08/17/15 08:50:22 AM
#39325   Unless there is something about the FDA and neuroinv 08/16/15 08:25:00 PM
#39324   Neuro, Could you expand on that and what you bridgrace 08/15/15 11:53:11 PM
#39323   Zero. neuroinv 08/15/15 02:26:20 PM
#39322   Neuro, What do you think Cortex's chances are of bridgrace 08/14/15 10:23:43 AM
#39321   Thanks Neuro, OT - >> Anavex << gfp927z 08/14/15 10:02:51 AM
#39320   Gfp: Re: Anavex. I've known Christopher Missling for--must be neuroinv 08/13/15 10:04:02 PM
#39319   There is no bottom. sparkyone 08/07/15 05:30:48 PM
#39318   Joey. Congrats. Looks like you called the bottom. drfreely 08/04/15 08:45:59 PM
#39317   Neuro, If you're out there, I was gfp927z 07/31/15 12:11:49 PM
#39316   Joey. Last summer was a good time to drfreely 07/23/15 12:51:10 PM