IRVINE, Calif.--(BUSINESS WIRE)--February 23, 2007--
Cortex Pharmaceuticals, Inc. (AMEX: COR), presenting at the 19th Annual Roth Capital Partners Growth Stock Conference on Wednesday, February 21st, reported that it had generated data which indicated that the histopathological changes previously reported for its lead AMPAKINE(R) product candidate, CX717, occurred postmortem in the animal tissue. If similar tissue was rapidly removed from animals and placed in an appropriate buffered medium, the tissue showed no signs of any histopathological changes and was physiologically normal... Yea it's CX717 it's back.
After earlier preclinical histopathological tissue results were reviewed by the FDA, the agency initiated a clinical hold for CX717 in March 2006. At the request of the FDA, Cortex conducted extensive additional animal toxicology studies during the summer of 2006 and in October 2006 the agency lifted the clinical hold, but placed significant dosage limitations on the use of CX717 in clinical trials. These limitations meant that Cortex could not proceed with further clinical assessments of CX717 in ADHD patients. CX717 had earlier demonstrated positive results in a pilot ADHD study in adult patients in a pilot Phase IIa study in March 2006. Cortex is planning to submit this new preclinical data to the FDA in March (Timely Folks!) with a request to have the dosage limitations changed so that it can proceed to conduct further clinical trials of CX717 in adult ADHD patients. Dr. Stoll, the Chief Executive Officer of Cortex, cautioned that the final decision on the adequacy of the data to allow the Company to proceed clinically is up to the FDA. Not getting the cadavar part in relation to this if we quickly rip off our skin and replace it the drug will work? This has got to be good news for Lifecell! LIFC
Dr. Stoll also mentioned during his presentation that the FDA had just issued a notice that will require that all current manufacturers of ADHD drugs issue Patient Medication Guides that spell out the risks of the current medications with respect to cardiovascular and psychiatric adverse events observed with the currently approved therapies. Dr. Stoll noted that the potential for a new therapeutic approach to the treatment of ADHD is clear and, if clinically safe and effective, CX717 could meet many of the current market needs. Dr. Stoll reiterated that the 3-week study in adult ADHD patients randomized to either CX717 or placebo, in a cross-over design, was both clinically and statistically significant on both decreasing hyperactivity and increasing attention on the primary ADHD rating scale which is the primary measure by which all ADHD products are approved.
Another point made by Dr. Stoll during the presentation at the Roth Conference was that the most recent studies by Dr. Gary Lynch at UC Irvine using a high impact AMPAKINE drug, CX929, showed very encouraging results in transgenic mice with the Huntington's Disease gene. CX929 not only returned depressed levels of BDNF (brain derived neurotrophic factor) back to normal, restored long term potentiation and most recently showed significant improvements in behavioral effects in the transgenic mouse model. Huntington's not sure the largeness of that patient poulation. But ADHD is big time.
The remaining topics covered by Dr. Stoll included an update on the low-impact AMPAKINE CX701 which Cortex anticipates commencing clinical trials by July 2007, the likelihood of a new research and development collaboration for its high-impact AMPAKINE compounds, (did somebody say Partnership?) and the in-licensing of a new Phase II non- AMPAKINE orphan drug.
This all looks very good biobottom well I guess first thing we do is check back Oct 06 when it got the limited go ahead and see how the stock reacted-- if it's signifcantly lower now I'd have to say any bad news is kind of baked in despite the rally...
Cortex Pharmaceuticals, Inc. (AMEX: COR), presenting at the 19th Annual Roth Capital Partners Growth Stock Conference on Wednesday, February 21st, reported that it had generated data which indicated that the histopathological changes previously reported for its lead AMPAKINE(R) product candidate, CX717, occurred postmortem in the animal tissue. If similar tissue was rapidly removed from animals and placed in an appropriate buffered medium, the tissue showed no signs of any histopathological changes and was physiologically normal... Yea it's CX717 it's back.
After earlier preclinical histopathological tissue results were reviewed by the FDA, the agency initiated a clinical hold for CX717 in March 2006. At the request of the FDA, Cortex conducted extensive additional animal toxicology studies during the summer of 2006 and in October 2006 the agency lifted the clinical hold, but placed significant dosage limitations on the use of CX717 in clinical trials. These limitations meant that Cortex could not proceed with further clinical assessments of CX717 in ADHD patients. CX717 had earlier demonstrated positive results in a pilot ADHD study in adult patients in a pilot Phase IIa study in March 2006. Cortex is planning to submit this new preclinical data to the FDA in March (Timely Folks!) with a request to have the dosage limitations changed so that it can proceed to conduct further clinical trials of CX717 in adult ADHD patients. Dr. Stoll, the Chief Executive Officer of Cortex, cautioned that the final decision on the adequacy of the data to allow the Company to proceed clinically is up to the FDA. Not getting the cadavar part in relation to this if we quickly rip off our skin and replace it the drug will work? This has got to be good news for Lifecell! LIFC
Dr. Stoll also mentioned during his presentation that the FDA had just issued a notice that will require that all current manufacturers of ADHD drugs issue Patient Medication Guides that spell out the risks of the current medications with respect to cardiovascular and psychiatric adverse events observed with the currently approved therapies. Dr. Stoll noted that the potential for a new therapeutic approach to the treatment of ADHD is clear and, if clinically safe and effective, CX717 could meet many of the current market needs. Dr. Stoll reiterated that the 3-week study in adult ADHD patients randomized to either CX717 or placebo, in a cross-over design, was both clinically and statistically significant on both decreasing hyperactivity and increasing attention on the primary ADHD rating scale which is the primary measure by which all ADHD products are approved.
Another point made by Dr. Stoll during the presentation at the Roth Conference was that the most recent studies by Dr. Gary Lynch at UC Irvine using a high impact AMPAKINE drug, CX929, showed very encouraging results in transgenic mice with the Huntington's Disease gene. CX929 not only returned depressed levels of BDNF (brain derived neurotrophic factor) back to normal, restored long term potentiation and most recently showed significant improvements in behavioral effects in the transgenic mouse model. Huntington's not sure the largeness of that patient poulation. But ADHD is big time.
The remaining topics covered by Dr. Stoll included an update on the low-impact AMPAKINE CX701 which Cortex anticipates commencing clinical trials by July 2007, the likelihood of a new research and development collaboration for its high-impact AMPAKINE compounds, (did somebody say Partnership?) and the in-licensing of a new Phase II non- AMPAKINE orphan drug.
This all looks very good biobottom well I guess first thing we do is check back Oct 06 when it got the limited go ahead and see how the stock reacted-- if it's signifcantly lower now I'd have to say any bad news is kind of baked in despite the rally...