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RespireRx Pharmaceuticals Inc. (RSPI)

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Last Post: 5/2/2016 11:22:17 AM - Followers: 157 - Board type: Free - Posts Today: 3




RespireRx Pharmaceuticals (formerly Cortex), 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 -

RespireRx website - http://www.respirerx.com/



Clinical Trials -
************************************



--- Dronabinol - Phase 2b in Obstructive Sleep Apnea, data due Q3-16

--- CX-1739 - Phase 2a in Opioid Induced Respiratory Depression, planned to start 2016

--- CX-1739 - Phase 2a in Central Sleep Apnea, planned to start in 2016

--- CX-1739 / CX-717 - Phase 2a in Spinal Damage, Pompe Disease, pending funding

--- CX-717 - Combination formulation with Opioids to reduce Respiratory Depression



Preclinical -
**************************


--- CX-1942 -
Injectible 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. Preclinical

--- Dronabinol - Extended Release Formulation planned


___________________________________________________________________


Summary of Clinical Programs -

___________________________________________________________________



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 Q3-16, fully funded $5 mil from the NIH


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.  A total of 4 major centers involved in the study.


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. 



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


AMPAKINES - Allosteric upmodulators of the AMPA receptor
*****************************


--- CX-1739 - Phase 2a in Opioid Induce Respiratory Depression, planned to start 2016


--- CX-1739 - Phase 2a in Central Sleep Apnea, planned to start in 2016



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. Preclinical
_____________________________________________________________________________

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, as well as Propofol (and benzodiazepines), clinical areas without 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 2016


Barbiturate, Propofol, Benzodiazapine Induced Respiratory Depression


Sleep Apnea ---- (positive Phase 2a data with CX-1739)


--- Phase 2a with CX-1739 in Central Sleep Apnea planned to start in 2016


Respiratory aspects of -

Pompe Disease,
Spinal Cord Damage,
Perinatal Respiratory Distress
Heart Failure Patients 
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


__________________________________________________________

RespireRx company website:
http://www.respirerx.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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RSPI News: Amended Current Report Filing (8-k/a) 04/12/2016 04:32:04 PM
RSPI News: Current Report Filing (8-k) 04/11/2016 05:19:10 PM
RSPI News: Current Report Filing (8-k) 04/06/2016 04:32:05 PM
RSPI News: Statement of Changes in Beneficial Ownership (4) 04/04/2016 06:19:36 PM
RSPI News: Statement of Changes in Beneficial Ownership (4) 04/04/2016 06:05:16 PM
PostSubject
#39482   Re waiting. Good move. No funding equals no trial. drfreely 05/02/16 11:22:16 AM
#39481   Re waiting. Good move. No funding equals no trial. drfreely 05/02/16 11:21:06 AM
#39480   Re waiting. Good move. No funding equals no trial. drfreely 05/02/16 11:21:05 AM
#39479   I want to put a few dollars, but Jumpinjackas 05/01/16 01:01:09 PM
#39478   IMHO funding RSPI will be the ultimate test drfreely 04/29/16 03:27:12 PM
#39477   No update from Co. I wonder b if Jumpinjackas 04/28/16 04:23:45 PM
#39476   A reverse split/recap makes sense and is long drfreely 04/22/16 11:15:51 AM
#39475   Drfreely, I'm starting to think they might gfp927z 04/11/16 07:37:00 PM
#39474   Lets get it started in here. Time to drfreely 04/11/16 02:27:36 PM
#39473   No updates thus far. So, they must still Jumpinjackas 04/08/16 08:54:13 AM
#39472   Funding-wise, it's still not clear where the company gfp927z 03/29/16 11:18:36 PM
#39471   Return of CX-717 (continued) - gfp927z 03/29/16 09:51:07 PM
#39470   The return of CX-717 --> Interesting info from gfp927z 03/29/16 09:04:49 PM
#39469   $RSPI RespireRx Pharmaceuticals Inc. Files December 31, 2015 $Pistol Pete$ 03/29/16 05:37:12 PM
#39468   APU_85, >> CX1739 for RD trial instead gfp927z 03/28/16 06:53:50 PM
#39467   Davidal, That sounds about right, a 50-1 gfp927z 03/28/16 05:53:00 PM
#39466   How do I bring up the chart of hayitahen 03/20/16 01:54:28 AM
#39465   GFP, do you know the reason why they apu_85 03/18/16 03:19:12 PM
#39464   I believe fully diluted there are something like davidal66 03/17/16 07:11:22 PM
#39463   Any guesses on the nature of a reverse davidal66 03/17/16 07:09:40 PM
#39462   Jumpinjack, >> Probably a RS and/or dilution gfp927z 03/16/16 08:51:56 PM
#39461   There is a mil size ask @.026. Probably Jumpinjackas 03/15/16 01:02:43 PM
#39460   $RSPI Daily and Weekly Charts http://www.stock $Pistol Pete$ 03/15/16 12:58:55 PM
#39459   I wonder if we will learn anything new tonight. Jumpinjackas 03/15/16 11:18:44 AM
#39458   $RSPI RespireRx Pharmaceuticals Inc. to Present at the $Pistol Pete$ 03/11/16 12:29:32 PM
#39457   Thanks. I know for a fact they are Jumpinjackas 03/11/16 11:59:50 AM
#39456   Jumpinjack, In his recent presentation, Dr. Manuso gfp927z 03/11/16 11:56:21 AM
#39455   Dronabinol: When are they supposed to complete the enrollment? Jumpinjackas 03/10/16 02:22:35 PM
#39454   Bought a few shares. Small lotto play. Jumpinjackas 03/08/16 01:05:05 PM
#39453   This son-of-a-gun just won't die, will it??? RBlatch45 03/07/16 10:55:50 AM
#39452   Kudos to management for getting FDA hold lifted. drfreely 03/03/16 03:57:00 PM
#39451   Davidal, Aiming - Good to see you guys gfp927z 03/01/16 11:33:48 AM
#39450   Hey davidal66, I agree, it's nice to see Aiming4 03/01/16 01:27:31 AM
#39449   Well done RSPI getting rid of the clinical davidal66 02/29/16 06:39:13 PM
#39448   $RSPI RespireRx Pharmaceuticals Inc. Announces Removal of FDA $Pistol Pete$ 02/29/16 09:30:05 AM
#39447   Good news on the wire: ampakines live to bridgrace 02/29/16 08:19:44 AM
#39446   I want a RS done first. I still Jumpinjackas 02/22/16 12:45:48 PM
#39445   Friday is the big day: FDA has until bridgrace 02/21/16 05:23:17 PM
#39444   There was a time when a story like haysaw 02/12/16 05:49:37 PM
#39443   Joey, Yes, it might be going sub-penny, gfp927z 02/09/16 02:27:29 PM
#39442   In yesterday's presentation, Dr. Manuso said they are gfp927z 02/09/16 02:02:40 PM
#39441   Holy freakin crap this stock blows, I have Joey Rosa 02/09/16 01:20:43 PM
#39440   Some upcoming events to watch for - gfp927z 02/04/16 11:19:52 PM
#39439   Nice promo video. They are talking a apu_85 02/04/16 05:48:04 PM
#39438   We are going nowhere fast. sparkyone 02/04/16 12:17:42 PM
#39437   Holy crap that's a lot of selling! Joey Rosa 02/01/16 04:10:05 PM
#39436   OT - Regulatory capture is an interesting topic, gfp927z 01/23/16 02:46:42 PM
#39435   Sparky, OT - When the FDA shoots gfp927z 01/22/16 08:45:22 PM
#39434   No. I won't go overboard like I did sparkyone 01/22/16 04:53:32 PM
#39433   Sparky, >> this one will keep flying, gfp927z 01/21/16 09:17:54 PM
PostSubject