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RespireRx Pharmaceuticals Inc. (RSPI)

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Last Post: 9/29/2016 12:01:58 PM - Followers: 182 - 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 -
**************************


--- 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.


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/
 
__________________________________________________________________

Sept 2016 - Reverse split 1 for 325

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124684119
__________________________________________________________________

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
__________________________________________________________________________________

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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RSPID News: Current Report Filing (8-k) 09/28/2016 05:05:26 PM
RSPID News: Current Report Filing (8-k) 09/28/2016 06:05:55 AM
RSPID News: UPDATE - RespireRx Pharma Announces Preliminary Top-Line Analysis of Data From Duke University Phase 2A Clinical Trial of CX1... 09/12/2016 08:02:00 PM
RSPID News: Current Report Filing (8-k) 09/12/2016 09:13:02 AM
RSPID News: RespireRx Pharma. Announces Preliminary Top-Line Analysis of Data From Duke University Phase 2A Clinical Trial of CX1739 09/12/2016 08:30:00 AM
PostSubject
#39763   I agree. I don't know for sure senderos 09/29/16 12:01:58 PM
#39762   Senderos, Yes, lukewarm. They may not gfp927z 09/29/16 12:00:24 PM
#39761   I had not seen this 8K, so good senderos 09/29/16 11:11:17 AM
#39760   Yes, not a great sign if they can't gfp927z 09/29/16 11:06:11 AM
#39759   8K: typical COR/CORX/RSPI b.s. This company hasn't had drfreely 09/28/16 12:00:12 PM
#39758   Glad I sold. The 8k does not look good. Jumpinjackas 09/28/16 08:43:53 AM
#39757   Snore..... drfreely 09/26/16 09:06:34 AM
#39756   At least they didn't dilute it the day Jumpinjackas 09/15/16 11:47:40 AM
#39755   Agreed. The bigger binary event is the Dec Jumpinjackas 09/14/16 12:44:15 PM
#39754   Could be party to deal got cold feet drfreely 09/14/16 12:40:14 PM
#39753   It seems the RS and trail data. We Jumpinjackas 09/14/16 10:48:36 AM
#39752   You make a good point. Previous management had drfreely 09/13/16 11:57:31 AM
#39751   They really need money to do a decent Jumpinjackas 09/13/16 10:19:24 AM
#39750   Somee Curiousnes about CSA in2it 09/12/16 08:33:26 PM
#39749   Jumpin, Yes, respiratory trials are tricky to gfp927z 09/12/16 03:10:18 PM
#39748   It probably comes back to the complexity of Jumpinjackas 09/12/16 02:34:40 PM
#39747   Jumpin, Yes, a lot of questions, gfp927z 09/12/16 02:32:24 PM
#39746   Trial result didn't seem like much of a Jumpinjackas 09/12/16 12:40:29 PM
#39745   The new slide deck for the R+R presentation gfp927z 09/12/16 12:01:13 PM
#39744   Good news from trial. Now there will be drfreely 09/12/16 10:33:40 AM
#39743   It appears that way to me also. senderos 09/12/16 09:56:59 AM
#39742   Results appear mixed. Maybe due to low cohort size Jumpinjackas 09/12/16 09:53:29 AM
#39741   RespireRx Pharmaceuticals Inc. Announces Preliminary Top-Line Analysis of haysaw 09/12/16 08:40:28 AM
#39740   I think most sold. Remember, it ran from Jumpinjackas 09/11/16 08:12:38 PM
#39739   Also... how many of Sheff's Sheeple are still GetSeriousOK 09/11/16 04:56:30 PM
#39738   That's the fun of playing pennystock biotech. GetSeriousOK 09/11/16 04:42:54 PM
#39737   I wonder where it goes tomorrow with positive news? Jumpinjackas 09/11/16 04:25:53 PM
#39736   I got some funding if they announce financing Jumpinjackas 09/10/16 05:27:46 PM
#39735   Manuso says he is "[looking] forward to discussing GetSeriousOK 09/10/16 05:24:39 PM
#39734   I bought a few shares at 4 twice. Jumpinjackas 09/10/16 04:14:30 PM
#39733   THANK YOU Sheff. I bought this week under GetSeriousOK 09/10/16 09:59:12 AM
#39732   This stock hit 3 pre split once upon drfreely 09/09/16 05:44:10 PM
#39731   35??? senderos 09/09/16 05:41:26 PM
#39730   Chef maybe will buy back in when it drfreely 09/09/16 05:23:27 PM
#39729   Geesh. We were only up 42% today. senderos 09/09/16 05:12:00 PM
#39728   We'll likely get a Monday press release of gfp927z 09/09/16 04:57:45 PM
#39727   I guess we are down today because of Jumpinjackas 09/09/16 02:14:52 PM
#39726   I'm sure he did that already. He bought Jumpinjackas 09/09/16 02:14:07 PM
#39725   SO what was the point of the Chef ARBITRARY & CAPRICIOUS 09/09/16 01:42:14 PM
#39724   I guess the sheep sold on the perfect Jumpinjackas 09/09/16 01:27:09 PM
#39723   So preliminary topline results from the CX-1739 RD gfp927z 09/09/16 11:05:29 AM
#39722   I know. The float is teeny. senderos 09/09/16 10:40:12 AM
#39721   Can you imagine if the results are released Jumpinjackas 09/09/16 10:24:45 AM
#39720   lol Rogerthat1 09/09/16 10:18:49 AM
#39719   So far, so good. We've already hit senderos 09/09/16 09:52:56 AM
#39718   That's usually a nice buy signal lmao :-D Rogerthat1 09/09/16 09:51:24 AM
#39717   Lol thx Rogerthat1 09/09/16 09:51:09 AM
#39716   Wouldn't worry at this point. Chef sheep sold yesterday. Jumpinjackas 09/09/16 09:50:39 AM
#39715   Post RS stock PPS would roughly be at Rogerthat1 09/09/16 09:18:49 AM
#39714   Here it is: senderos 09/09/16 09:00:06 AM
PostSubject