Update on Cortex's CEO Presentation at the Roth Capital Partners 19th Annual Conference.IRVINE, Calif. -- Cortex Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange : COR), presenting at the 19th Annual Roth Capital Partners Roth Capital Partners, LLC, is a full service Investment Banking firm, specializing in the small and micro cap markets. Roth’s focus, according to its official website, "has been, is, and will continue to be providing the full spectrum of investment banking services, 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 postmortem /post·mor·tem/ (post-mort´im) performed or occurring after death. post·mor·tem adj. Relating to or occurring during the period after death. n. See autopsy. 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. After earlier preclinical histopathological tissue results were reviewed by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , 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 Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or 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 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. 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 ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to either CX717 or placebo, in a cross-over design cross-over design Clinical research A clinical trial design in which Pts receive, in sequence, the treatment–or the control, and then, after a specified time, are switched to the control–or treatment. See Crossover. , 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 Huntington's disease, hereditary, acute disturbance of the central nervous system usually beginning in middle age and characterized by involuntary muscular movements and progressive intellectual deterioration; formerly called Huntington's chorea. gene. CX929 not only returned depressed levels of BDNF BDNF Brain-Derived Neurotrophic Factor BDNF Beaverhead-Deerlodge National Forest (Montana) (brain derived neurotrophic factor) back to normal, restored long term potentiation potentiation /po·ten·ti·a·tion/ (po-ten?she-a´shun) 1. enhancement of one agent by another so that the combined effect is greater than the sum of the effects of each one alone. 2. posttetanic p. and most recently showed significant improvements in behavioral effects in the transgenic mouse model. 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, and the in-licensing of a new Phase II non- AMPAKINE orphan drug. A replay of the presentation will be available for 30 days and can be accessed via the following link: http://www.wsw.com/webcast/roth9/cor/. More information regarding the conference can be found at http://www.rothconference.com/. About Cortex 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[R] 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 or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. for the treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested. 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 mild cognitive impairment (MCI), n memory loss generally associated with aging; does not affect normal independent functioning of an individual. , Alzheimer's disease and anxiety disorders. For additional information regarding Cortex, please visit Cortex Pharmaceuticals' Website at www.cortexpharm.com. NOTE -- THIS PRESS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS WITH RESPECT TO FUTURE REGULATORY ACTIONS BY THE FDA, INTERPRETATIONS OF PRE-CLINICAL TOXICOLOGY RESULTS AND ANTICIPATED RESULTS OF FUTURE CLINICAL TRIALS AND THE POSSIBLE CLINICAL USES OF AMPAKINE COMPOUNDS, ALL OF WHICH ARE DIFFICULT OR IMPOSSIBLE TO PREDICT ACCURATELY AND MANY OF WHICH ARE BEYOND THE CONTROL OF CORTEX, ALL AS MORE FULLY DESCRIBED IN THE RISK FACTORS AND OTHER MATTERS SET FORTH IN CORTEX'S ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2005, AND CORTEX'S OTHER FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. CORTEX DISCLAIMS ANY INTENT OR OBLIGATION TO UPDATE ANY FORWARD-LOOKING STATEMENTS. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion