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Last Post: 8/5/2014 9:00:39 PM - Followers: 150 - Board type: Free - Posts Today: 0

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 - http://www.cortexpharm.com/



Dronabinol -  Targeting Obstructive Sleep Apnea.  
****************

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.


http://clinicaltrials.gov/ct2/show/NCT01755091?term=dronabinol+apnea&rank=1


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.

 

MECHANISM OF ACTION
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. 


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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 -
************

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) - http://www.cortexpharm.com/news/2011/020211.html

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82872921

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CX-1942 - Water soluble prodrug of CX-1763 for intravenous use, targeting Respiratory Depression
_____________________________________________________________________________

CX-2076 - Backup compound to CX-1739, awaiting IND enabling studies
_____________________________________________________________________________

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) - http://www.drugs.com/clinical_trials/cortex-s-ampakine-molecule-cx717-has-positive-opiate-induced-respiratory-depression-phase-iia-5253.html

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82872525

ADHD Phase 2a results (CX-717) - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82879930

Sleep Deprivation Phase 2a results (CX-717) (UK study) - cbi.nlm.nih.gov/pmc/articles/PMC1188239/

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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


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Key Press Releases -

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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 -

http://finance.yahoo.com/news/cortex-pharmaceuticals-inc-enters-license-093000953.html

http://www.sec.gov/Archives/edgar/data/849636/000149315214002061/form8k.htm
__________________________________________________________________

Aug 14, 2012 - Cortex announces merger with Pier Pharmaceuticals in an all stock transaction -
http://www.cortexpharm.com/news/2012/081412.html
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Oct 6, 2011 -- Servier Exercises Option to Cortex's Ampakine CX1632, an Innovative Compound in Clinical Development for Alzheimer's Disease  -- http://investorshub.advfn.com/boards/read_msg.aspx?message_id=69802851
__________________________________________________________________________________
Aug 24, 2011 -- Cortex Receives U.S. Patent for the use of Ampakine Molecules to Treat Respiratory Depression -- http://investorshub.advfn.com/boards/read_msg.aspx?message_id=69803347
__________________________________________________________________________________
Apr 26, 2011 -- Cortex Receives Granted US Patent for its Lead AMPAKINE® Molecule CX-1739
-- http://investorshub.advfn.com/boards/read_msg.aspx?message_id=69802247
__________________________________________________________________________________
Mar 16, 2011 -- Cortex Reacquires all Ampakine Compounds, Related Patents and Exclusive Global Rights for Respiratory Depression from Biovail  --  http://investorshub.advfn.com/boards/read_msg.aspx?message_id=69803128
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Feb 2, 2011 -- CX-1739 Improves Respiratory Parameters In Obstructive Sleep Apnea Patients --http://investorshub.advfn.com/boards/read_msg.aspx?message_id=69802205

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82872921
__________________________________________________________________________________
Jul 6, 2010 - Funding from The Michael J. Fox Foundation to discover drug candidates for Parkinson's disease -- http://investorshub.advfn.com/boards/read_msg.aspx?message_id=69802108
__________________________________________________________________________________
Aug, 2008 - Cortex's AMPAKINE Molecule CX717 Has Positive Effects in Opiate-Induced Respiratory Depression in a Phase IIa Clinical Study - http://www.drugs.com/clinical_trials/cortex-s-ampakine-molecule-cx717-has-positive-opiate-induced-respiratory-depression-phase-iia-5253.html

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82872525
__________________________________________________________________________________
Q1-2006 - ADHD Phase 2a results (CX-717) - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82879930


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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)
Barbiturate Induced Respiratory Depression
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)
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1188239/
Depression
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)
Narcolepsy



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




Cortex company website:
http://www.cortexpharm.com/

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


Patent database : Ampa related patents -
http://v3.espacenet.com/results?TI=ampa&sf=a&DB=EPODOC&PGS=10&CY=ep&LG=en&ST...

Information website for Ampakines (not an official Cortex company website):
http://www.ampakines.org/index.htm

Research Paper abstracts for "Ampakines":
http://www.neurotransmitter.net/ampakines.html

Yahoo Cortex Message Board:
http://finance.yahoo.com/mb/CORX/

Silicon Investor Cortex Message Board:
http://www.siliconinvestor.com/subject.aspx?subjectid=3299

SEC Filings -
http://sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000849636&owner=exclude&count=40




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CORX News: Quarterly Report (10-q) 07/30/2014 08:05:35 AM
CORX News: Current Report Filing (8-k) 07/23/2014 04:33:28 PM
CORX News: Statement of Changes in Beneficial Ownership (4) 07/21/2014 05:30:39 PM
CORX News: Current Report Filing (8-k) 07/01/2014 08:01:02 AM
CORX News: Cortex Pharmaceuticals, Inc. Enters Into New License Agreement With the University of Illinois Granting Cortex Patent Rights ... 07/01/2014 05:30:00 AM
PostSubject
#39132   The Dr. Lippa I know and love IPO'd drfreely 08/05/14 09:00:39 PM
#39131   Cannabinoid Profiles - THC, THCA, THCV, CBD, CBG, gfp927z 08/03/14 10:26:03 AM
#39130   BOD meeting was July 17 - gfp927z 08/02/14 06:06:08 PM
#39129   10-Q - gfp927z 08/02/14 06:00:32 PM
#39128   Here's a Cannabis related I-Hub thread I started gfp927z 07/26/14 09:12:54 AM
#39127   Hi Neuro, Just curious if you've been gfp927z 07/26/14 08:52:45 AM
#39126   On the medical side, marinol for appetite stimulation atheroprevent 07/22/14 10:56:49 AM
#39125   Ouch! greenfield101 07/17/14 10:26:09 PM
#39124   Two marketing avenues for a generic sleep apnea drug. drfreely 07/17/14 07:32:55 PM
#39123   Since I am not aware of any plan neuroinv 07/17/14 12:16:53 PM
#39122   Neuro, Any idea about how they get around the brigrajac 07/17/14 12:08:12 AM
#39121   You can't have bias without 'BS'. Nice to haysaw 07/12/14 07:26:26 PM
#39120   Apparently the FDA can grant fast-track status if Dogleg9 07/09/14 02:56:37 PM
#39119   Anyone have any idea about the length of DewDiligence 07/09/14 01:39:00 PM
#39118   Gfp: It's good to hear from you, glad to neuroinv 07/08/14 06:53:24 PM
#39117   >>> Got a great investing idea? Start your gfp927z 07/04/14 07:50:11 PM
#39116   Early Phase 2. Enough said alphaInvestor2 07/02/14 10:12:25 PM
#39115   "The use of dronabinol for the treatment of Hlong 07/02/14 03:29:54 PM
#39114   >>> Item 1.01 Entry into a Material Definitive gfp927z 07/02/14 01:48:34 PM
#39113   A few thoughts based on the press release - gfp927z 07/02/14 01:07:59 PM
#39112   You just had to bring up PARS, didn't CHM_760 07/01/14 08:40:12 PM
#39111   Cannabinoids - Unfortunately reminds me of another disastrous tonyvanw 07/01/14 08:32:23 PM
#39110   Gee - It looks like it is time PATCOcontroller 07/01/14 01:16:29 PM
#39109   CORX THE NEXT GWPH?---CORX working on CANNABINOID treatment meltup 07/01/14 12:29:38 PM
#39108   Well, well, there is life in the old trailheadmike 07/01/14 12:03:33 PM
#39107   On this very thread, I suggested cortex do food4thought 06/15/14 12:59:21 PM
#39106   Somebody spent 6000 American dollars on Cortex stock today. subuclayton 06/13/14 10:56:13 PM
#39105   Great point Ace! Market_Fest4 06/13/14 04:26:28 PM
#39104   Were are those defending Varney/Stoll as victims of drfreely 06/13/14 04:17:38 PM
#39103   I still have 10 or 20K shares. Market_Fest4 06/13/14 03:52:24 PM
#39102   No one has anything to say? haysaw 06/13/14 01:12:04 PM
#39101   So funny but true. Sad, and I am sparkyone 06/13/14 10:19:58 AM
#39100   Biotech Index Soaring. CORX at three pennies. drfreely 06/11/14 08:02:20 AM
#39099   indeed. anyone still holding ? alertmeipp 06/10/14 12:26:57 AM
#39098   No one has anything to say? sparkyone 06/09/14 01:45:55 PM
#39097   Hahaha Hilarious!!!!!! Butterfingers 05/18/14 06:36:33 AM
#39096   Sleep Apnea -- >>> US approves first-of-its-kind implant gfp927z 05/02/14 01:31:42 PM
#39095   Underground research with CX-717 continues to show amazing gfp927z 04/22/14 09:06:42 AM
#39094   Braderin, >>> They totally believe in the gfp927z 04/21/14 10:49:25 PM
#39093   I speak to the new executives once every braderin 04/21/14 10:31:07 PM
#39092   Looks like the recent activity reduced the company's gfp927z 04/21/14 10:29:21 PM
#39091   Does anybody still follow CORX? Does anybody Market_Fest4 04/19/14 01:46:11 PM
#39090   It lives!!!! It lives!!!!!! RBlatch45 04/01/14 02:13:14 PM
#39089   Another AD drug bombs out -- >>> Prana gfp927z 03/31/14 09:33:26 AM
#39088   Fwiw, >>> Form 8-K for CORTEX PHARMACEUTICALS gfp927z 03/26/14 10:47:03 AM
#39087   Cannibistex arises? subuclayton 03/24/14 05:58:21 PM
#39086   FDA Moves Forward With Marijuana-Based Drug To Fight greenfield1 03/07/14 06:43:46 PM
#39085   Ok so after the merger with pier pharmacy criscros 02/28/14 10:08:41 PM
#39084   Still no response from Management from my 11/12/13 drfreely 02/03/14 03:29:36 PM
#39083   With anything remotely cannabis related going into the gfp927z 02/01/14 09:37:59 AM
PostSubject