cnelson
07-17-2007, 09:35 AM
Cortex To Resume Clinical Trial With AMPAKINE(R) CX717 In Alzheimer-PET Scan Study After FDA Approves Protocol With Higher Doses Of Drug
Been holding since April waiting for this news. Looking forward to seeing what this does to the Bid/Ask today! This should open higher!
Sell the news, or hold for long term???---
IRVINE, Calif., Jul 17, 2007 (BUSINESS WIRE) -- Cortex Pharmaceuticals, Inc.
(AMEX: COR), announced that following review of the AMPAKINE(R) CX717 data
package sent to the Food & Drug Administration's (FDA) Division of Neurology
Products (DNP) on April 17, 2007, the FDA responded that Cortex can immediately
resume enrollment in the CX717 Alzheimer's positron emission tomography (PET)
scan study at all requested dose levels. The study was originally designed with
doses of 200mg, 600mg, and 1200mg to be administered to the patients. However,
the agency had previously limited the dose levels such that the 600mg and 1200mg
doses could not be administered. The new protocol approved by the agency allows
a return to the original dose levels, with the upper dose being 1200mg.
Dr. Roger Stoll, Chief Executive Officer of Cortex, stated, "With the removal of
the dose restrictions, the Company can now resume studying CX717 at all desired
dose levels. This important double-blinded study will attempt to determine if we
can duplicate the striking PET scan findings in non-human primates which
correlated with increased cognitive performance published by Dr. Deadwyler in
PLOS Biology in September 2005." The clinical study is being performed in
mild-moderate Alzheimer's patients who are drug naive or stabilized on
cholinesterase inhibitors at the University of Michigan Medical Center. In
animal studies cholinesterase inhibitors such as Aricept(R) and Reminyl(R)
appear to enhance the effects of CX717.
The earlier dose limitations imposed by the FDA were related to concerns over
data from preclinical animal studies and were not related to any findings from
human clinical trials. The DNP plans to continue their review of the data
package, but saw no reason not to permit the full resumption of the current
AD-PET scan study. Cortex will continue to have further discussions with the DNP
regarding the previously submitted toxicology package and additional
requirements may be requested by the FDA.
Cortex intends to file a second IND for CX717 with the Division of Psychiatry
Products (DPP) during the 3rd Quarter of 2007 to allow the Company to initiate a
Phase IIB study evaluating CX717 for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD). Since the DNP was where the original clinical
hold was issued and where the subsequent release of the clinical hold with
dosage limitations was granted, Cortex recognized that a decision from that
division of the FDA was needed before proceeding with a filing in another
division (DPP) for the same drug product.
"We are gratified that all our hard work has succeeded in moving the development
of CX717 forward and we have to thank some very diligent employees, consultants,
and advisors for their help with this complicated issue," added Dr. Stoll. "It
is a credit to our researchers and our Company that an issue of such complexity
could be unraveled and permit Cortex to proceed with the development of this new
and novel treatment for some serious CNS diseases."
About Cortex Pharmaceuticals
Cortex, located in Irvine, California, is a neuroscience company focused on
novel drug therapies for neurological and psychiatric disorders. The Company is
pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds,
which act to increase the strength of signals at connections between brain
cells. The loss of these connections is thought to be responsible for memory and
behavior problems in Alzheimer's disease. Many psychiatric diseases, including
schizophrenia, occur as a result of imbalances in the brain's neurotransmitter
system. These imbalances may be improved by using the AMPAKINE technology.
Cortex has alliances with N.V. Organon for the treatment of schizophrenia and
depression and with Les Laboratoires Servier for the development of AMPAKINE
compounds to treat the neurodegenerative effects associated with aging and
disease, including Mild Cognitive Impairment, Alzheimer's disease and anxiety
disorders. (http://www.cortexpharm.com/)
Been holding since April waiting for this news. Looking forward to seeing what this does to the Bid/Ask today! This should open higher!
Sell the news, or hold for long term???---
IRVINE, Calif., Jul 17, 2007 (BUSINESS WIRE) -- Cortex Pharmaceuticals, Inc.
(AMEX: COR), announced that following review of the AMPAKINE(R) CX717 data
package sent to the Food & Drug Administration's (FDA) Division of Neurology
Products (DNP) on April 17, 2007, the FDA responded that Cortex can immediately
resume enrollment in the CX717 Alzheimer's positron emission tomography (PET)
scan study at all requested dose levels. The study was originally designed with
doses of 200mg, 600mg, and 1200mg to be administered to the patients. However,
the agency had previously limited the dose levels such that the 600mg and 1200mg
doses could not be administered. The new protocol approved by the agency allows
a return to the original dose levels, with the upper dose being 1200mg.
Dr. Roger Stoll, Chief Executive Officer of Cortex, stated, "With the removal of
the dose restrictions, the Company can now resume studying CX717 at all desired
dose levels. This important double-blinded study will attempt to determine if we
can duplicate the striking PET scan findings in non-human primates which
correlated with increased cognitive performance published by Dr. Deadwyler in
PLOS Biology in September 2005." The clinical study is being performed in
mild-moderate Alzheimer's patients who are drug naive or stabilized on
cholinesterase inhibitors at the University of Michigan Medical Center. In
animal studies cholinesterase inhibitors such as Aricept(R) and Reminyl(R)
appear to enhance the effects of CX717.
The earlier dose limitations imposed by the FDA were related to concerns over
data from preclinical animal studies and were not related to any findings from
human clinical trials. The DNP plans to continue their review of the data
package, but saw no reason not to permit the full resumption of the current
AD-PET scan study. Cortex will continue to have further discussions with the DNP
regarding the previously submitted toxicology package and additional
requirements may be requested by the FDA.
Cortex intends to file a second IND for CX717 with the Division of Psychiatry
Products (DPP) during the 3rd Quarter of 2007 to allow the Company to initiate a
Phase IIB study evaluating CX717 for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD). Since the DNP was where the original clinical
hold was issued and where the subsequent release of the clinical hold with
dosage limitations was granted, Cortex recognized that a decision from that
division of the FDA was needed before proceeding with a filing in another
division (DPP) for the same drug product.
"We are gratified that all our hard work has succeeded in moving the development
of CX717 forward and we have to thank some very diligent employees, consultants,
and advisors for their help with this complicated issue," added Dr. Stoll. "It
is a credit to our researchers and our Company that an issue of such complexity
could be unraveled and permit Cortex to proceed with the development of this new
and novel treatment for some serious CNS diseases."
About Cortex Pharmaceuticals
Cortex, located in Irvine, California, is a neuroscience company focused on
novel drug therapies for neurological and psychiatric disorders. The Company is
pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds,
which act to increase the strength of signals at connections between brain
cells. The loss of these connections is thought to be responsible for memory and
behavior problems in Alzheimer's disease. Many psychiatric diseases, including
schizophrenia, occur as a result of imbalances in the brain's neurotransmitter
system. These imbalances may be improved by using the AMPAKINE technology.
Cortex has alliances with N.V. Organon for the treatment of schizophrenia and
depression and with Les Laboratoires Servier for the development of AMPAKINE
compounds to treat the neurodegenerative effects associated with aging and
disease, including Mild Cognitive Impairment, Alzheimer's disease and anxiety
disorders. (http://www.cortexpharm.com/)