Cortex Initiates Enrollment in Opiate Induced Respiratory Depression Clinical Trial in Germany Today
March 31 2008 - 7:29AM
Business Wire
Cortex Pharmaceuticals, Inc. (AMEX: COR,
http://www.cortexpharm.com), was notified by the German regulatory
agency which approves the use of narcotic drugs that it can proceed
with the trial which will use alfentanil, an opiate analgesic. With
this approval the enrollment of subjects into the dose response
study evaluating the ability of CX717 to prevent respiratory
depression caused by opiate analgesics has begun. The study is a
placebo controlled, double blinded, cross-over design with three
doses of CX717compared to placebo. Depending on the pace of
subjects being enrolled, Cortex at this point believes that
top-line data will be available from this study by the end of June,
2008. Currently, the only available means of preventing respiratory
depression induced by the combination of multiple opioids
medications like fentanyl, morphine and codeine in the operating
room is either to have the patients re-intubated in order to attach
them to a respirator or to utilize opioid reversal agents, such as
naloxone (Narcan�). Intubation is a costly procedure and may lead
to additional days of hospitalization. The use of. naloxone, a
narcotic antagonist, eliminates the analgesic effect of the opioid
medication as well as countering the respiratory depression, which
is considered a significant drawback to its use. If the German
AMPAKINE� studies are successful, pre-surgical or post- surgical
administration of CX717 could potentially improve the safety margin
for giving these powerful analgesic agents, which would provide a
valuable tool for anesthesiologists and surgeons to optimize pain
management in surgical patients. This would be especially true in
high risk surgical patients such as those over the age of
sixty-five, those with a history of sleep apnea, respiratory
illnesses or obese patients. Further information about the design
of the two clinical studies which the Company is conducting in
Germany can be obtained by reading the press release on the initial
approval by the BfArM issued on March 3, 2008. Cortex
Pharmaceuticals, Inc. is a neuroscience company located in Irvine,
California that focused on the discovery and clinical development
of AMPAKINE� molecules, a platform technology that represents a new
approach to treating psychiatric disorders, neurological diseases
and brain mediated breathing disorders. The Company has pioneered a
novel class of proprietary pharmaceuticals called AMPAKINE
compounds that positively modulate the AMPA-type glutamate receptor
complex, amplifying the effect of the most prominent brain
neurotransmitter, glutamate at the synapse, leading to excitation
of brain circuits that appear to affect memory, cognition and a
unique brain stem structure thought to be responsible for
inspiratory drive and the maintenance breathing rhythm. Many
neurodegenerative disorders could potentially benefit from enhanced
binding of glutamate by AMPAKINE compounds, which has been
demonstrated in standard animal models of Alzheimer�s, Huntington�s
diseases, Parkinson�s disease and potential uses in many other
neurodegenerative diseases. Many psychiatric diseases, including
Attention Deficit Hyperactivity Disorders (ADHD), depression, and
schizophrenia occur as a result of imbalances in the brain�s
neurotransmitter system. Proof of Concept in adult ADHD patients
has been demonstrated with CX717. Cortex currently has an alliance
with Schering-Plough (formerly Organon) for the treatment of
schizophrenia and depression. In 2006 Cortex terminated its
research collaboration with Les Laboratoires Servier and in turn
worldwide rights to neurodegenerative diseases, sexual dysfunction,
and anxiety were returned to Cortex. Servier retained three
compounds from the research collaboration and may develop them for
neurodegenerative diseases, sexual dysfunction, and anxiety in all
markets in the original license. For additional information
regarding Cortex, please visit Cortex Pharmaceuticals� Website at
www.cortexpharm.com. PLEASE NOTE; Cortex is currently changing its
website, www.cortexpharm.com, and anticipates that it will be
available for use before the end of April, 2008. At that time
additional data related to the use of AMPAKINE� drugs in the
treatment of respiratory depression can be obtained from that site.
Forward-Looking Statement Note - This press release contains
forward-looking statements concerning the Company's research and
development activities. The success of such activities depends on a
number of factors, including the risks that the Company's proposed
compounds may at any time be found to be unsafe or ineffective for
the indications under clinical test and that clinical studies may
at any point be suspended or take substantially longer than
anticipated to complete. As discussed in the Company's Securities
and Exchange Commission filings, the Company's proposed products
will require additional research, lengthy and costly clinical
testing and regulatory approval. AMPAKINE compounds are
investigational drugs and have not been approved for the treatment
of any disease.
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