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Last Post: 10/31/2014 5:39:21 PM - Followers: 150 - Board type: Free - Posts Today: 1

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: Annual Report (10-k) 10/14/2014 08:33:29 AM
CORX News: Statement of Changes in Beneficial Ownership (4) 09/05/2014 05:11:53 PM
CORX News: Initial Statement of Beneficial Ownership (3) 09/05/2014 05:06:08 PM
CORX News: Statement of Changes in Beneficial Ownership (4) 09/05/2014 11:42:12 AM
CORX News: Initial Statement of Beneficial Ownership (3) 09/05/2014 11:33:24 AM
PostSubject
#39200   OT - Airborne Ebola - CDC says Ebola gfp927z 10/31/14 05:39:21 PM
#39199   A pretty good rundown of what's up with drfreely 10/27/14 01:17:33 PM
#39198   Curious to see if CORX was still alive jakeb 10/26/14 11:05:30 PM
#39197   Anyone know if Cortex could help with this: http://www.chicagotribune.com/lifes bamorr01 10/25/14 10:24:39 AM
#39196   1.5 BILLION SHARES!!!???? in2it 10/23/14 01:27:22 PM
#39195   OT - The US Govt reportedly has 8 gfp927z 10/19/14 12:05:47 PM
#39194   http://www.cnn.com/2014/10/16/showbiz/joan-rivers-cause-of-death/index.html A apu_85 10/16/14 02:25:54 PM
#39193   Based on the 10K and CORX holding steady drfreely 10/15/14 05:42:15 PM
#39192   After reading the 10K and noting the new drfreely 10/15/14 05:31:57 PM
#39191   Drfreely, >> Too early for a secondary << gfp927z 10/14/14 11:31:55 AM
#39190   10-K - gfp927z 10/14/14 10:48:57 AM
#39189   Got my trade I put on last week. drfreely 10/09/14 11:47:55 AM
#39188   OT.... brain mapping atheroprevent 10/08/14 10:28:54 AM
#39187   Okay, so it did! krk 10/07/14 06:15:22 PM
#39186   Praise the Lord!!! haysaw 10/02/14 12:24:29 PM
#39185   As an experiment I put in a 8000 drfreely 10/02/14 11:43:57 AM
#39184   Breaking .08 level could start the push we criscros 09/26/14 03:04:42 PM
#39183   Also intriguing to me. This source of funding davidal66 09/25/14 11:26:31 PM
#39182   No mention if the funding will be sufficient drfreely 09/25/14 12:01:31 PM
#39181   I am happy with the direction. It sparkyone 09/25/14 10:15:12 AM
#39180   Good news. Funding with other people's money and criscros 09/25/14 09:00:22 AM
#39179   >>> Cortex Pharmaceuticals, Inc. Announces Phase 1 Funding gfp927z 09/24/14 09:17:12 AM
#39178   No low hanging fruit in neuro-pharmacology atheroprevent 09/23/14 09:32:33 AM
#39177   It makes no sense that Ampakines are just Market_Fest4 09/22/14 04:55:47 PM
#39176   Gfp, One other thing to note about cor's path. brigrajac 09/18/14 01:00:34 AM
#39175   Brigrajac, Thanks. It doesn't make sense that gfp927z 09/17/14 10:22:01 PM
#39174   Gfp, Almost never are they given together because -- brigrajac 09/17/14 07:26:40 PM
#39173   Re post 39163. Dr. Lippa. drfreely 09/17/14 04:02:38 PM
#39172   Brigrajac, >>> we worry about reversing gfp927z 09/17/14 12:56:58 PM
#39171   Anesthesiologists love Propofol --widely used but no drugs brigrajac 09/17/14 11:52:56 AM
#39170   Agreed, and especially Propofol. Dr. Lippa noted gfp927z 09/17/14 12:24:00 AM
#39169   Opiates are brilliant pain killers, science has found BollixMeArse 09/16/14 11:03:53 PM
#39168   Brigrajac, Here's the reply from the company, gfp927z 09/16/14 04:18:37 PM
#39167   With Dronabinol already being generic (and FDA approved gfp927z 09/16/14 03:38:55 PM
#39166   MarketFest, The Respiratory license/patent relationship with Univ gfp927z 09/16/14 02:45:49 PM
#39165   Hi Neuro, Sounds like CNS funding has gfp927z 09/16/14 12:57:42 PM
#39164   I thought the ampakines reverted back to the Market_Fest4 09/16/14 12:34:56 PM
#39163   Some info on Dr. Lippa - gfp927z 09/16/14 12:12:54 PM
#39162   Brigrajac, In the presentation Dr. Lippa says - gfp927z 09/16/14 11:47:55 AM
#39161   Looks like a very reasonable, pragmatic approach. The neuroinv 09/15/14 01:58:22 PM
#39160   GFP, Have you found out if the results of brigrajac 09/14/14 11:29:30 PM
#39159   Summary of CX-717 RD Phase 2a -- >>> gfp927z 09/14/14 07:52:39 AM
#39158   Thinking about Ampakines, the cognitive enhancement aspect will gfp927z 09/12/14 09:00:21 AM
#39157   I've never had doubts that ampakines have efficacy. drfreely 09/11/14 08:21:09 PM
#39156   >>> Cortex the comeback kid <<< gfp927z 09/11/14 07:12:51 PM
#39155   Boy, you got that right and I am meixatech 09/11/14 04:46:23 PM
#39154   Brigrajac, >>> analysis and helpful info <<< gfp927z 09/11/14 03:18:07 PM
#39153   GFP, Thanks so much for your analysis and helpful brigrajac 09/11/14 02:50:27 PM
#39152   Some backround on the Biovail RD deal - gfp927z 09/11/14 02:46:17 PM
#39151   Brigrajac, The last slide showed the Dronabinol gfp927z 09/11/14 02:36:03 PM
PostSubject