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Last Post: 4/20/2015 8:03:25 AM - Followers: 154 - 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 - http://www.cortexpharm.com/



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.


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

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

_____________________________________________________________________________

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) - 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/

________________________________________________________________________________


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 -

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
__________________________________________________________________________________
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
__________________________________________________________________________________
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


*********************************************************************************************

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)
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: Proxy Statement - Other Information (preliminary) (pre 14c) 04/23/2015 04:42:11 PM
CORX News: Statement of Changes in Beneficial Ownership (4) 04/21/2015 05:05:42 PM
CORX News: Initial Statement of Beneficial Ownership (3) 04/21/2015 04:55:59 PM
CORX News: Quarterly Report (10-q) 03/09/2015 08:37:19 AM
CORX News: Quarterly Report (10-q) 02/24/2015 08:41:09 AM
PostSubject
#39258   "Quo Vadis?" Dr. Lippa. drfreely 04/20/15 08:03:25 AM
#39257   Cannabis- The Good, The Bad And The Ugly... in2it 03/09/15 02:23:23 PM
#39256   10Q out today scstocks 03/09/15 12:51:50 PM
#39255   Yes by who? sparkyone 03/05/15 05:56:13 PM
#39254   The compound was being tested as a natural criscros 03/05/15 07:15:26 AM
#39253   Thank you, for the detailed response. sparkyone 03/04/15 04:53:33 PM
#39252   Delta 9 tetrahydrocannabol is the active ingredient responsible drfreely 03/04/15 03:56:22 PM
#39251   Delta 9? sparkyone 03/03/15 05:18:39 PM
#39250   These guys might have right to delta 9 criscros 02/26/15 08:23:09 PM
#39249   We have a long way to go before sparkyone 02/24/15 02:42:24 PM
#39248   Re: explode. Only wish it were so... drfreely 02/23/15 01:18:53 PM
#39247   If CORX has rights to delta 9 they criscros 02/19/15 11:03:18 AM
#39246   Cortex's 9 tetra compound in trial goes by drfreely 02/17/15 01:37:18 PM
#39245   Getting emails about a new painkiller delta 9 criscros 02/15/15 12:29:40 PM
#39244   Looks like money will come in dribs and drfreely 02/11/15 06:53:39 PM
#39243   >>> Form 8-K for CORTEX PHARMACEUTICALS INC/DE/ gfp927z 02/09/15 10:08:04 AM
#39242   Re: Bow Tie. See my post #39215, Paragraph #3. drfreely 01/26/15 12:11:14 PM
#39241   If anyone has some trading ideas, here is gfp927z 01/17/15 12:13:00 PM
#39240   Meixatech, Not so long a wait if gfp927z 01/14/15 12:34:46 PM
#39239   Nice presentation at the Biotech Showcase on Tuesday, gfp927z 01/14/15 11:46:17 AM
#39238   Wow. Neat. But a long wait meixatech 01/14/15 11:17:49 AM
#39237   Interview with Dr. Lippa - gfp927z 01/14/15 10:30:02 AM
#39236   >>> Cortex Pharmaceuticals, Inc. to Present at 7th gfp927z 01/10/15 12:48:04 PM
#39235   Annual Report (10-k) scstocks 01/06/15 12:55:58 PM
#39234   Agree, awesome science, but the Cortex lesson...not even atheroprevent 01/05/15 01:38:40 PM
#39233   ==Nanobubbles== Awesome, First I had heard of them. EOM scstocks 01/02/15 01:39:46 PM
#39232   Nanobubbles: Potent Potion, or Just Effervescence? haysaw 01/01/15 08:08:25 PM
#39231   re: ACRX (OT) bladerunner1717 12/30/14 02:26:40 PM
#39230   Cleaning out some long term storage I ran Market_Fest4 12/22/14 10:15:16 PM
#39229   GFp: This Wikipedia entry is seven years out of neuroinv 12/15/14 04:34:11 PM
#39228   Neuro, Thanks. gfp927z 12/14/14 12:47:10 PM
#39227   Neuro, Any thoughts on MRNS? bladerunner1717 12/14/14 08:47:09 AM
#39226   OT (TRGT) Any company with $90 million in neuroinv 12/13/14 11:31:51 AM
#39225   Hi Neuro. Hopefully Dr. Lippa can get gfp927z 12/12/14 06:07:39 PM
#39224   No, I organize an entirely different meeting, and neuroinv 12/12/14 04:55:34 PM
#39223   I wonder if Neuro might be involved with gfp927z 12/05/14 10:41:16 PM
#39222   >>> Cortex Pharmaceuticals, Inc. to Participate in 7th gfp927z 12/05/14 10:26:18 PM
#39221   SC, Those wanting to go long Cortex gfp927z 11/28/14 01:29:50 PM
#39220   thanks gfp, kicking myself I didn't slowly load scstocks 11/28/14 12:34:55 PM
#39219   SC, That 10-Q was in fact filed gfp927z 11/28/14 09:48:54 AM
#39218   hello,to be honest, I didn't read it as scstocks 11/26/14 09:20:34 PM
#39217   SC is that the latest? 1st Q 2013? atheroprevent 11/26/14 03:07:10 PM
#39216   10Q out today, link below EOM scstocks 11/24/14 05:58:13 PM
#39215   Damn right gfp! We need to get back drfreely 11/16/14 07:44:58 PM
#39214   Brigrajac, In the R+R presentation, Dr. Lippa gfp927z 11/14/14 10:01:34 PM
#39213   gfp, What about the strategy of trying to get brigrajac 11/13/14 06:58:26 PM
#39212   This is just the beginning of the new gfp927z 11/13/14 05:18:17 PM
#39211   I was thinking the very same thing....privy, greedy, bastard! food4thought 11/13/14 01:53:58 PM
#39210   Seems like my first post about the selling drfreely 11/13/14 12:58:32 PM
#39209   seems like it would be a sec slam scstocks 11/13/14 11:33:40 AM
PostSubject