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RespireRx Pharmaceuticals Inc. (RSPI)

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Last Post: 9/10/2019 11:40:36 AM - Followers: 167 - 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 - http://www.respirerx.com/



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 -
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--- 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


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Summary of Clinical Programs -

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Dronabinol -  Targeting Obstructive Sleep Apnea.  
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--- 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.


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. 

http://journal.frontiersin.org/article/10.3389/fpsyt.2013.00001/full


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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) -

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

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

Respiratory Depression - Phase 2a preliminary results (CX-1739) -

http://respirerx.com/respirerx-pharmaceuticals-inc-announces-preliminary-top-line-analysis-of-data-from-duke-university-phase-2a-clinical-trial-of-cx1739/




_____________________________________________________________________________

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) - 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/

_____________________________________________________________________________

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

http://respirerx.com/respirerx-pharmaceuticals-inc-announces-preliminary-top-line-analysis-of-data-from-duke-university-phase-2a-clinical-trial-of-cx1739/
 
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Sept 2016 - Reverse split 1 for 325

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124684119
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Dec 2015 - Cortex changes name to RespireRx

http://respirerx.com/news/
__________________________________________________________________

Aug 2015 - Dr. James Manuso becomes President and CEO

http://respirerx.com/news/
__________________________________________________________________

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
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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


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

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)
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

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


_____________________________________________________________


 

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RSPI News: Current Report Filing (8-k) 09/09/2019 05:16:17 PM
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RSPI News: Quarterly Report (10-q) 05/20/2019 04:09:49 PM
PostSubject
#40063   Agreed. Good luck to us. There aren’t many food4thought 09/10/19 11:40:36 AM
#40062   Well, IMO, there is something of value here. senderos 09/10/19 09:41:20 AM
#40061   Fingers crossed. At this point it’s a lottery ticket. food4thought 09/10/19 09:39:25 AM
#40060   Since 1996? Holy crap! You have senderos 09/10/19 09:26:28 AM
#40059   I am happy to see some smoke. senderos 09/10/19 09:25:15 AM
#40058   I took a position back in 2014 and Investor2014 09/10/19 08:19:30 AM
#40057   So you’re saying there’s a chance.... Been holding, loading, food4thought 09/10/19 08:17:31 AM
#40056   The old chaps are still alive and trying, Investor2014 09/10/19 07:29:02 AM
#40055   RespireRx Pharmaceuticals Inc. Executives Participating in the 2nd senderos 09/10/19 07:18:02 AM
#40054   https://seekingalpha.com/filing/4603323?app=1#/FORM10-Q_HTM_A_015 Same old. Jus Investor2014 08/14/19 06:05:53 PM
#40053   God I hope so.... food4thought 08/14/19 12:53:51 PM
#40052   Does anyone detect a pulse here? senderos 08/14/19 10:32:40 AM
#40051   Last ditch approach to earn some licensing dollars Investor2014 07/31/19 12:57:24 PM
#40050   NEWS! RESPIRERX PHARMACEUTICALS INC. SEND NOTICE LETTER TO THE senderos 07/31/19 10:02:17 AM
#40049   https://www.sec.gov/Archives/edgar/data/849636/000149315219005477/form10-k. Investor2014 04/17/19 04:05:32 AM
#40048   A time machine chance drfreely 04/06/19 11:17:03 AM
#40047   So you’re saying there’s a chance?! food4thought 04/04/19 12:33:28 PM
#40046   Re: Australia. Grasping at straws. This company died drfreely 04/04/19 11:18:44 AM
#40045   https://www.tga.gov.au/form/special-access-scheme Special Access Investor2014 02/26/19 11:52:02 AM
#40044   I don't care about "Hi Doc, we're here. Cincinnatus 02/26/19 09:41:39 AM
#40043   Sorry, I can't help with that. But senderos 02/25/19 05:04:47 PM
#40042   Can anyone supply more information about this Australian Cincinnatus 02/25/19 04:55:20 PM
#40041   I wrote Margolis this question today and he senderos 02/20/19 04:37:41 PM
#40040   Impression Healthcare: “Disrupting the mouthguard market Impression Healthcare Investor2014 02/20/19 01:22:51 PM
#40039   https://impression.healthcare/cannabinoid-therapeutics-axim-biotechnologies-incorporated-axim/ sparkyone 02/20/19 12:08:36 PM
#40038   From OTCQB certificate: senderos 02/19/19 02:19:18 PM
#40037   This is one patient management team. But senderos 02/19/19 02:11:28 PM
#40036   The next chapter in a book of a food4thought 02/19/19 12:48:34 PM
#40035   Could be the beginning of the next chapter Investor2014 02/19/19 12:46:35 PM
#40034   RespireRx Pharmaceuticals Inc. and Impression Healthcare Limited Announce senderos 02/19/19 09:25:57 AM
#40033   Food4, >> partner up with the Chinese << gfp927z 01/24/19 03:05:15 PM
#40032   Well maybe it’s time to partner up with food4thought 01/24/19 02:52:28 PM
#40031   Cincinnatus, I saw that glutamate related article in gfp927z 01/24/19 12:02:54 PM
#40030   Gfp can answer better to this, but my food4thought 01/24/19 09:59:33 AM
#40029   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5342457/ “Endocannabinoid control Investor2014 01/24/19 03:11:31 AM
#40028   Not a scientist. What does this info Cincinnatus 01/23/19 11:56:45 PM
#40027   >>> It may be possible to restore memory gfp927z 01/23/19 06:49:31 PM
#40026   We have a higher bid than I have senderos 01/10/19 09:51:09 AM
#40025   "Not all investigators are happy with the amount meixatech 01/04/19 03:31:14 PM
#40024   >>> What Happened to the Hominids Who May gfp927z 01/03/19 05:12:45 PM
#40023   RespireRx Pharmaceuticals Inc. Appoints James Sapirstein as Executive senderos 01/03/19 10:30:34 AM
#40022   Nice presentation. I learned something. Hoping senderos 12/21/18 06:10:11 AM
#40021   Here is the presentations given at the conference: https://www.sec.gov/Archives/edgar/data/8496 Investor2014 12/21/18 04:09:16 AM
#40020   The public cannot see the info until 2027. senderos 12/20/18 11:06:56 AM
#40019   Interesting about Confidential Treatment Order. At least RSPI apneaous 12/20/18 10:42:02 AM
#40018   Nice to see they are following up on Investor2014 12/10/18 01:22:20 PM
#40017   NEWS: Click on links to see that the RSPI senderos 12/10/18 09:57:50 AM
#40016   Yes and more to point both IF and when. Investor2014 12/07/18 05:06:40 PM
#40015   This stock has a certain jigginess to it, senderos 12/07/18 10:19:47 AM
#40014   Thanks for that. I missed it. senderos 12/01/18 07:24:38 AM
PostSubject