�Cortex Pharmaceuticals, Inc. (AMEX:
COR - News) reported that top-line data from its number one Phase IIa
study in opiate-induced respiratory depression (RD) demonstrated that
a single oral superman of 2100mg of AMPAKINE� CX717 achieved statistical
significance over placebo on the primary terminus measure. These
results are being presented at the Bank of Montreal Capital Markets
Focus on Healthcare Conference in New York City on Wednesday morning,
August 6, 2008 at 9:30AM (EDT) by Dr. Roger G. Stoll, President & CEO
of Cortex. This placebo controlled, double blind, randomized bipartite
crossover trial (RD-02) was performed by Parexel's clinical research
unit in Europe. In this study, eight (8) volunteers per cupid's disease group
each received either 900mg, 1500mg, or 2100mg of CX717 or matching
placebo that was by word of mouth administered two hours before each bailiwick
received an intravenous infusion of the opiate agonist, alfentanil.
The primary performance measures were derived from a CO2 re-breathing
procedure that measured the ventilation response of the subject to
increased CO2 levels in the presence of alfentanil. The primary
bar, the instant expiratory volume (VE) at 55mgHg CO2 (VE55), was
reversed by 2100 mg CX717 in comparison to placebo (p
No reliable responses were seen in the 900mg and 1500mg CX717 groups,
only procedural problems were detected by the Data Safety Monitoring
Board (DSMB) for this study, which was authorized by the protocol to
monitor safety and responses on an interim basis. Corrective
procedural changes were instituted before the initiation of the net
group of subjects in the 2100mg segment of the study.
"While we initiated this study victimisation oral doses of CX717 and had only
eight subjects per treatment chemical group, we were pleased to obtain
statistical significance using such small study groups," said Dr.
Roger Stoll the CEO of Cortex. The primary objective was to but
verify that the chemical mechanism, which was seen operation in animate being
studies, would also be operative in humans. Substantial investments
were required to develop an intravenous dose form of CX717,
including formulation developing and stability studies for such a
dosage form as well as deuce species toxicology trials. The Company now
feels that it lavatory proceed with such studies. Cortex latterly received
confirmation of three months of accelerated stability for the
experimental intravenous formulation of CX717 and plans to initiate
toxicology trials in the fourth quarter 2008.
A second respiratory depression study has been performed by a group
in Frankfurt, Germany. This study uses a single cupid's itch of 1500mg of
CX717 and focuses on both the respiratory depression and the
pain pill effects associated with alfentanil. The analysis of the
data has been initiated and related to results should be reported within
a few weeks. Studies of CX717 in animal models by Dr. John Greer at
the University of Alberta ingest shown that the AMPAKINE drugs do not
interfere with the analgesic personal effects of opiates.
Cortex continues to advance other AMPAKINE compounds, specially
those newer compounds that have potential difference patent lives to 2028. It
will also be reported at the BMO Capital Markets conference that
Cortex has initiated human phase one safety and kinetic trials with
CX1739 in normal volunteers. Assuming successful Phase I human trials
with this compound, the Company plans to rapidly pursue the Attention
Deficit-Hyperactivity disorder indication for CX1739 in the second
half of 2009. The Company will also written report on an initial creature trial
with CX1942, a unique pro-drug analog of another humbled impact AMPAKINE
drug that is highly water soluble, ideally suited for an intravenous
dosage form. This compound speedily hydrolyzes to the parent AMPAKINE
drug in vivo. CX1942 has shown exceptionally rapid results in
reversing respiratory low due to intravenously administered
fentanyl in rats. The Company plans to initiate toxicology studies
with this unique parallel during the last quarter of 2008.
High impact AMPAKINE compounds from recent patent applications are
as well being ripe with a focus on neurodegenerative diseases, such
as Alzheimer's and Parkinson's diseases, as easily as orphan drug
indications like Huntington's and Fragile X disease.
The conference presentation roved for the discussion of whatsoever disease. Cortex
disclaims any intent or obligation to update whatsoever forward-looking
statements.
Cortex Pharmaceuticals, Inc.
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