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RespireRx Pharmaceuticals Inc. (RSPI)

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Last Post: 8/17/2017 4:12:43 AM - Followers: 171 - Board type: Free - Posts Today: 0

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 -

Clinical Trials -

--- Dronabinol - Phase 2b in Obstructive Sleep Apnea, data due Q4 2016

--- CX-1739 - Phase 2a in Opioid Induced Respiratory Depression, data Sept 12, 2016

--- CX-1739 - Phase 2a in Central Sleep Apnea - planned, pending funding

--- CX-1739 / CX-717 - Phase 2a trials possible in the Respiratory aspects of Pompe Disease, Spinal Cord Injury, Perinatal Respiratory Distress - pending funding

--- CX-717 - Possible 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, data due Q4-16, 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. Data due in Q4 2016.  

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.

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

Respiratory -

Opioid Induced Respiratory Depression -

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

--- Phase 2a with CX-1739 - data Sept 12, 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 - pending funding

Respiratory aspects of -

Pompe Disease
Spinal Cord Damage
Perinatal Respiratory Distress
Heart Failure Patients 
Sickle Cell Crisis


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 - (do not upregulate BDNF - Brain Derived Neurotrophic Factor)

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

Phase 2a completed in Opioid Induced Respiratory Depression - preliminary results Sept 2016 (link below).

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) -

Respiratory Depression - Phase 2a preliminary 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. 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) -

ADHD Phase 2a results (CX-717) -

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


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

CX-2076 - Low impact compound, preclinical


High Impact Ampakines - (upregulate BDNF)
While this approach is not actively being advanced by RespireRx at this time, the High Impact type of Ampakines have the ability to upregulate BDNF and other brain growth factors, and therefore 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 were awaiting funding/partnership.     

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

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

CX-1837 - High impact 


Key Press Releases -


Sept 12, 2016 - Preliminary data for CX-1739 Respiratory Depression Phase 2a

Sept 2016 - Reverse split 1 for 325

Dec 2015 - Cortex changes name to RespireRx

Aug 2015 - Dr. James Manuso becomes President and CEO

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) -


In addition to Respiratory indications, Ampakines have the potential to address Neuro/Psych areas that range from orphan indications to $1 Billion plus sized markets -

Neuro / Psych - (Not actively being pursued by RespireRx at this time)

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)


RespireRx 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":

SEC Filings -



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RSPI News: Quarterly Report (10-q) 08/14/2017 10:47:21 AM
RSPI News: Statement of Changes in Beneficial Ownership (4) 07/28/2017 07:09:33 PM
RSPI News: Amended Current Report Filing (8-k/a) 07/18/2017 06:05:05 AM
RSPI News: Current Report Filing (8-k) 07/11/2017 05:21:18 PM
RSPI News: Current Report Filing (8-k) 07/07/2017 04:11:45 PM
#39831   Good points and questions. I've lost so much on Investor2014 08/17/17 04:12:43 AM
#39830   Seems like getting fifteen cents on every dollar drfreely 08/15/17 03:01:42 PM
#39829   The Company owns patents and patent applications, or Jumpinjackas 08/14/17 03:34:51 PM
#39828   It seems like he thinks this will become Jumpinjackas 08/14/17 03:01:21 PM
#39827   Some news on funding (if it arrives) check drfreely 08/14/17 02:48:46 PM
#39826   No news on funding or phase III. Jumpinjackas 08/10/17 11:11:43 AM
#39825   Bridgrace, Looking at the most recent presentation gfp927z 07/25/17 03:09:01 PM
#39824   gfp Any thoughts on the studies and strategic plan, bridgrace 07/23/17 03:31:18 PM
#39823   Hate to say it, but the feeling one gfp927z 07/22/17 05:19:19 PM
#39822   Re: "The funding issue". Think lack of funding drfreely 07/19/17 09:41:30 AM
#39821   Tons of information posted yesterday with very good apu_85 07/12/17 12:50:23 PM
#39820   Hope the stock awards and salary uplift is Investor2014 07/09/17 09:45:02 AM
#39819   Congrats to management on pay raise and stock drfreely 07/09/17 08:41:50 AM
#39818   Re: Hope. Manuso to investors: "Brother, can you drfreely 06/17/17 11:21:35 AM
#39817   Agree. Seems like there could still be hope. Investor2014 06/16/17 08:39:24 PM
#39816   Strongest and most concrete presentation to date from apu_85 06/16/17 12:53:26 PM
#39815   This is sad. sparkyone 06/02/17 03:51:53 PM
#39814   Food4thought From what I gather he is still looking sparkyone 05/19/17 10:38:25 AM
#39813   Thanks for sharing..... Boy could I write "Dear JEFFREY" food4thought 05/18/17 05:40:02 PM
#39812   Dear Jeffrey, sparkyone 05/18/17 04:00:05 PM
#39811   Any signs we'll get ampakines back in trials drfreely 05/01/17 03:45:35 PM
#39810   Looks like they were able to convince someone drfreely 04/03/17 06:30:48 PM
#39809   Note that Form 10-K was issued on 3/31/17: Dogleg9 04/02/17 12:58:41 PM
#39808   Looks like this 8-k is showing $50k and apu_85 03/16/17 10:42:08 PM
#39807   If anyone out there has Level 2, I'd gfp927z 03/08/17 02:28:50 PM
#39806   Quiet place this board and hope you are Investor2014 03/08/17 02:10:34 PM
#39805   Fwiw, the RSPI chart has shown a flat/truncated gfp927z 03/08/17 08:22:58 AM
#39804   no news on this at all. neither the questinfy 03/03/17 03:35:00 PM
#39803   We have been running at several times normal senderos 03/02/17 02:26:37 PM
#39802   They are not quiet. Read their filings. Someone Jumpinjackas 02/28/17 01:42:28 PM
#39801   why is this company/stock so silent. When is questinfy 02/27/17 10:59:44 PM
#39800   Could this be the year when RSPI climbs Jumpinjackas 02/24/17 10:46:50 AM
#39799   Nice. They still need money...It never seems to Jumpinjackas 02/17/17 11:37:35 PM
#39798   >>> RespireRx Pharmaceuticals Inc. to Present at BIO gfp927z 02/10/17 05:56:20 PM
#39797   Food4, I just finished listening to Dr. gfp927z 01/17/17 03:11:05 PM
#39796   Hey GFP, I always look forward to your in food4thought 01/17/17 02:03:06 PM
#39795   >>> RespireRx Pharmaceuticals Inc. to Present at 9th gfp927z 01/17/17 12:14:40 PM
#39794   Looking further, I see Dr. Manuso presented at gfp927z 01/17/17 12:05:22 PM
#39793   As always... They need money Jumpinjackas 01/17/17 10:09:57 AM
#39792   Food4, >> a setup for a financing gfp927z 01/16/17 11:44:17 PM
#39791   No question. They would have to cure cancer food4thought 01/14/17 06:45:38 PM
#39790   Have you calculated the price level needed for subuclayton 01/13/17 08:27:06 PM
#39789   Two days worth of strong volume with an food4thought 01/12/17 04:10:48 PM
#39788   Don't look now, but we are slowly creeping upward. senderos 01/10/17 10:52:03 AM
#39787   The Dronabinol program appears to be on solid gfp927z 12/24/16 10:00:25 AM
#39786   Very nice summary of where we are. senderos 12/24/16 06:46:19 AM
#39785   Looks like this confirms the positive results from gfp927z 12/23/16 01:18:51 PM
#39784   Another big day like this and we will subuclayton 12/23/16 11:53:50 AM
#39783   So what's the next step..... Funding, dilution, financing? Clearly a food4thought 12/23/16 11:33:47 AM
#39782   We are coming back to life here. senderos 12/23/16 10:00:45 AM