NEOT news of interest, last time it went to $20
NeoTherapeutics and CSL Announce Significant
Clinical Improvements Seen With New Drug for
Alzheimer's Disease
IRVINE, Calif., June 2 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT,
NEOTW) and Clinical Studies Ltd., Providence, RI, presented results from its
recently completed Phase 2a clinical trial of NEOTROFIN(TM) in patients with
Alzheimer's disease. The data from this study was presented today at the 39th
Annual Meeting of the New Clinical Drug Evaluation Unit (NCDEU), in Boca Raton,
FL.
Steven Targum, M.D., of Clinical Studies Ltd., the principle investigator of this
clinical trial, presented data describing the use of NeoTherapeutics' novel drug as a
potential treatment for patients with mild to moderate Alzheimer's disease.
Seventy-five subjects were enrolled in the double-blind study which tested
NEOTROFIN(TM) at three dose levels or placebo for 28 days of treatment. These
subjects were evaluated again after a 28 day period in which no drug was given, to
determine potential longer term effects of the drug.
In patients with Alzheimer's disease, the NEOTROFIN(TM) treated group showed
an improvement from baseline testing in the ADAS-cog, a measure of cognitive
functioning, after 28 days of administration. Total ADAS-cog scores improved in
72% of patients receiving the 150mg dose. The Global Behave-AD test, a measure
of behavioral symptoms such as aggressiveness and anxiety, revealed statistically
significant positive differences between drug groups and the placebo group.
Additionally, the CIBIC-plus, a measure of overall disease severity, demonstrated a
marked improvement in the drug treated groups and the positive effects of the drug
were observed for an additional 28 days after the drug was stopped.
"Improvements in memory function and behavior suggest that NEOTROFIN(TM)
may have therapeutic benefit in patients with Alzheimer's disease," said Dr.
Targum. He added, "Larger studies of longer duration with NEOTROFIN(TM) are
needed to ascertain the sustained cognitive benefit of this drug and evaluate the
potential to modify the progression of Alzheimer's disease."
Dr. Michelle Glasky, Vice President of Scientific Affairs at NeoTherapeutics
commented, "We designed this study to look at trends after a relatively short
28-day treatment period. We are pleasantly surprised with the robustness of the
data. Because of the small number of patients per group, these results exceeded
our expectations."
NEOTROFIN(TM) is NeoTherapeutics' lead compound and is being developed for
nerve repair and regeneration, with Alzheimer's disease as its first clinical
indication. Pre-clinical studies have demonstrated that NEOTROFIN(TM) can
control the production of multiple natural neurotrophic factors and restore function
in animal models of aging, brain injury and spinal cord injury.
Clinical Studies Ltd. is a Site Management Organization with approximately 35
clinical sites throughout the United States. The New Clinical Drug Evaluation Unit
(NCDEU) Meeting is a scientific conference sponsored by the National Institute of
Mental Health which brings together clinicians and researchers from academia or
the pharmaceutical industry with representatives from the NIMH and the FDA.
NeoTherapeutics' research strategy is focused on designing small molecules
capable of passing through the blood brain barrier for the therapy for a range of
neurological diseases and conditions. Compounds in NeoTherapeutics' product
pipeline address health issues such as Alzheimer's disease and dementia,
Parkinson's disease, stroke, spinal cord injury, migraine, depression and obesity.
For additional Company information, visit the NeoTherapeutics web site at
www.neotherapeutics.com. |
