Monday, July 30, 2018 7:20:35 PM
>>> RespireRx Pharmaceuticals Inc. Announces Resignation of Dr. James S. Manuso
Press Release
06/19/2018
https://www.otcmarkets.com/stock/RSPI/news/RespireRx-Pharmaceuticals-Inc-Announces-Resignation-of-Dr-James-S-Manuso?id=195932
Glen Rock, N.J, June 19, 2018 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. announces the decision of Dr. James S. Manuso to resign as president, CEO, Vice Chairman and member of the Board of Directors (“Board”) of the Company, effective as of September 30, 2018, the expiration date of his contract. He will remain in these positions until that date.
In commenting on his decision, Dr. Manuso stated, “It has been a rewarding and value-enhancing experience to manage, help finance and bring RespireRx to its Phase 3 dronabinol clinical trial readiness. I look forward to assisting the Company as an advisor and shareholder going forward.”
“We thank Jim for his years of service to RSPI,” said Dr. Arnold Lippa, Executive Chairman of the Board and Chief Scientific Officer of the Company. The Board of the Company looks forward to benefiting from his management during the remaining term of his appointment as president, CEO, Vice Chairman and Board member.”
In the future, Dr. Manuso will devote his full time attention to the management of Talfinium Investments Inc., a healthcare investment and merchant banking firm he established in 2013.
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the development of medicines for respiratory disorders and CNS indications, with a focus on obstructive sleep apnea, attention deficit hyperactivity disorder (ADHD), spinal cord injury, other neurological conditions and drug-induced respiratory depression. The Company holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.
Cannabinoids. RespireRx is developing dronabinol, a synthetic derivative of a naturally occurring substance in the cannabis plant, for the treatment of OSA, a serious respiratory disorder that impacts an estimated 29.4 million people in the United States according to the American Academy of Sleep Medicine (“AASM”), published in August 2016. OSA has been linked to increased risk for hypertension, heart failure, depression, and diabetes, and has an annual economic cost in the United States of $162 billion according to the AASM. There are no approved drug treatments for OSA.
RespireRx believes, pending the outcome of an intended meeting with the FDA, that it will be able to commence a Phase 3 clinical study for the treatment of OSA with dronabinol. The Company further believes that it would only require approval by the FDA of a 505(b)(2) new drug application (“NDA”), an efficient regulatory pathway.
RespireRx believes that the most direct route to commercialization is to proceed directly to a Phase 3 pivotal trial using the currently available dronabinol formulation (2.5, 5 and 10 mg gel caps) and to then commercialize a RespireRx branded dronabinol capsule (“RBDC”).
RespireRx also believes that there are numerous opportunities for reformulation of dronabinol to produce a second-generation proprietary, branded product for the treatment of OSA with an improved profile. Therefore, simultaneous with the development of the RBDC, RespireRx plans to develop a proprietary dronabinol formulation to optimize the dose and duration of action for treating OSA.
Ampakines. The second platform of proprietary medicines being developed by RespireRx are ampakines, which act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors. Several ampakines, in both oral and injectable forms, are being developed by the Company for the treatment of a variety of breathing and CNS disorders. In clinical studies of respiratory function, select ampakines have shown preliminary efficacy in central sleep apnea and in the control of respiratory depression produced by opioids, without altering the opioid analgesic effects. In animal models of certain orphan disorders, such as Pompe Disease, Rett’s Syndrome and perinatal respiratory distress, certain ampakines have been shown to improve breathing function.
Ampakines also have shown potential as possible therapeutic agents for the treatment of certain neuropsychiatric and neurological disorders. Ampakines have demonstrated positive activity in animal models of ADHD, results that have been extended translationally into statistically significant improvement of symptoms observed in a Phase 2 clinical trial of CX717 in adults with ADHD. At present, the major pharmacotherapies available for ADHD are made up of two types of drugs. Stimulants, such as amphetamine, rapidly produce robust effects, but suffer from side effects typical of stimulants, including tolerance, dependence, withdrawal and abuse. For these reasons, stimulants are scheduled by the FDA. Non-stimulants, such as Straterra® (atomoxetine) tend to be less effective than stimulants, with a much longer (approximately 4 – 8 week) latency to onset of action. In a number of animal and human studies, CX717 and other ampakines did not display any stimulant properties typically associated with drugs like amphetamine. In the Phase 2 ADHD clinical trial, statistically significant therapeutic effects were observed within one week. Therefore, we believe ampakines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative non-stimulant treatment options.
RespireRx owns certain composition of matter and use patents and patent applications with respect to ampakines CX1739, CX717 and other amakines. The Company has received notice from the University of Alberta that purports to terminate the Company’s license in respect of patents associated with respiratory applications of ampakines. RespireRx has been in contact with the University of Alberta and anticipates engaging in a dispute resolution process with respect to its license with the University of Alberta in respect to use patents associated only with respiratory applications of ampakines.
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Press Release
06/19/2018
https://www.otcmarkets.com/stock/RSPI/news/RespireRx-Pharmaceuticals-Inc-Announces-Resignation-of-Dr-James-S-Manuso?id=195932
Glen Rock, N.J, June 19, 2018 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. announces the decision of Dr. James S. Manuso to resign as president, CEO, Vice Chairman and member of the Board of Directors (“Board”) of the Company, effective as of September 30, 2018, the expiration date of his contract. He will remain in these positions until that date.
In commenting on his decision, Dr. Manuso stated, “It has been a rewarding and value-enhancing experience to manage, help finance and bring RespireRx to its Phase 3 dronabinol clinical trial readiness. I look forward to assisting the Company as an advisor and shareholder going forward.”
“We thank Jim for his years of service to RSPI,” said Dr. Arnold Lippa, Executive Chairman of the Board and Chief Scientific Officer of the Company. The Board of the Company looks forward to benefiting from his management during the remaining term of his appointment as president, CEO, Vice Chairman and Board member.”
In the future, Dr. Manuso will devote his full time attention to the management of Talfinium Investments Inc., a healthcare investment and merchant banking firm he established in 2013.
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the development of medicines for respiratory disorders and CNS indications, with a focus on obstructive sleep apnea, attention deficit hyperactivity disorder (ADHD), spinal cord injury, other neurological conditions and drug-induced respiratory depression. The Company holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.
Cannabinoids. RespireRx is developing dronabinol, a synthetic derivative of a naturally occurring substance in the cannabis plant, for the treatment of OSA, a serious respiratory disorder that impacts an estimated 29.4 million people in the United States according to the American Academy of Sleep Medicine (“AASM”), published in August 2016. OSA has been linked to increased risk for hypertension, heart failure, depression, and diabetes, and has an annual economic cost in the United States of $162 billion according to the AASM. There are no approved drug treatments for OSA.
RespireRx believes, pending the outcome of an intended meeting with the FDA, that it will be able to commence a Phase 3 clinical study for the treatment of OSA with dronabinol. The Company further believes that it would only require approval by the FDA of a 505(b)(2) new drug application (“NDA”), an efficient regulatory pathway.
RespireRx believes that the most direct route to commercialization is to proceed directly to a Phase 3 pivotal trial using the currently available dronabinol formulation (2.5, 5 and 10 mg gel caps) and to then commercialize a RespireRx branded dronabinol capsule (“RBDC”).
RespireRx also believes that there are numerous opportunities for reformulation of dronabinol to produce a second-generation proprietary, branded product for the treatment of OSA with an improved profile. Therefore, simultaneous with the development of the RBDC, RespireRx plans to develop a proprietary dronabinol formulation to optimize the dose and duration of action for treating OSA.
Ampakines. The second platform of proprietary medicines being developed by RespireRx are ampakines, which act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors. Several ampakines, in both oral and injectable forms, are being developed by the Company for the treatment of a variety of breathing and CNS disorders. In clinical studies of respiratory function, select ampakines have shown preliminary efficacy in central sleep apnea and in the control of respiratory depression produced by opioids, without altering the opioid analgesic effects. In animal models of certain orphan disorders, such as Pompe Disease, Rett’s Syndrome and perinatal respiratory distress, certain ampakines have been shown to improve breathing function.
Ampakines also have shown potential as possible therapeutic agents for the treatment of certain neuropsychiatric and neurological disorders. Ampakines have demonstrated positive activity in animal models of ADHD, results that have been extended translationally into statistically significant improvement of symptoms observed in a Phase 2 clinical trial of CX717 in adults with ADHD. At present, the major pharmacotherapies available for ADHD are made up of two types of drugs. Stimulants, such as amphetamine, rapidly produce robust effects, but suffer from side effects typical of stimulants, including tolerance, dependence, withdrawal and abuse. For these reasons, stimulants are scheduled by the FDA. Non-stimulants, such as Straterra® (atomoxetine) tend to be less effective than stimulants, with a much longer (approximately 4 – 8 week) latency to onset of action. In a number of animal and human studies, CX717 and other ampakines did not display any stimulant properties typically associated with drugs like amphetamine. In the Phase 2 ADHD clinical trial, statistically significant therapeutic effects were observed within one week. Therefore, we believe ampakines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative non-stimulant treatment options.
RespireRx owns certain composition of matter and use patents and patent applications with respect to ampakines CX1739, CX717 and other amakines. The Company has received notice from the University of Alberta that purports to terminate the Company’s license in respect of patents associated with respiratory applications of ampakines. RespireRx has been in contact with the University of Alberta and anticipates engaging in a dispute resolution process with respect to its license with the University of Alberta in respect to use patents associated only with respiratory applications of ampakines.
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