IRVINE, Calif., Jan. 27 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT,
NEOTW) announced today that NEOTROFIN(TM) (AIT-082, leteprinim potassium)
produced a positive effect on behavioral function as well as memory
improvement in a Phase 2 clinical study involving patients with Alzheimer's
disease. This double-blinded, placebo-controlled, Phase 2a study enrolled
74
patients with mild to moderate Alzheimer's disease for twenty-eight days of
treatment. NEOTROFIN(TM) was safe and well tolerated when doses from 50 to
500 mg were administered once daily for twenty-eight days.
"These preliminary results represent the first positive clinical finding
with
NEOTROFIN(TM) on standard behavioral function tests in addition to memory
improvement in patients with Alzheimer's disease" said Dr. Alvin J. Glasky,
President and Chief Scientific Officer of NeoTherapeutics. "These new
clinical results extends the observations we have seen in the earlier Phase
1
clinical studies which evaluated single and multiple doses of NEOTROFIN(TM)
(AIT-082) in healthy volunteers and a single dose study in patients with
Alzheimer's disease. Further, we are encouraged that these results may be
based upon the unique basis of action of NEOTROFIN(TM), which in
pre-clinical
studies demonstrated enhanced nerve regeneration. NEOTROFIN(TM) could mark
the beginning of a new era of hope for the four million Americans suffering
from Alzheimer's disease," Dr. Glasky stated.
Steven Targum, M.D. of Clinical Studies Ltd., the principal investigator on
the study which involved 13 clinical centers in the United States, stated
"We
are very pleased that in this Phase 2a clinical trial, NEOTROFIN(TM)
demonstrated benefits in Alzheimer's disease patients within 28 days of
treatment. If these observations are confirmed and expanded upon in larger
clinical trials, NEOTROFIN(TM) could be an important new medication for the
management of Alzheimer's disease."
NEOTROFIN(TM) is NeoTherapeutics' lead compound and is being developed for
nerve 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.
NeoTherapeutics' research program is focused on designing and developing
small
molecules capable of promoting nerve regeneration and repair for a range of
neurological diseases and conditions such as Alzheimer's and Parkinson's
diseases, stroke and spinal cord injury. Additional compounds in
NeoTherapeutics' product pipeline address other health issues such as
migraine
and depression. For additional Company information, visit the
NeoTherapeutics
web site at www.neotherapeutics.com.
This press release contains forward-looking statements regarding future
events
and the future performance of NeoTherapeutics that involve risks and
uncertainties that could cause actual results to differ materially. These
risks include, but are not limited to, the early stage of product
development,
the need for additional funding, the initiation and completion of clinical
trials and dependence on third parties for clinical testing, manufacturing
and
marketing. These risks are described in further detail in the Company's
reports filed with the Securities and Exchange Commission.
SOURCE NeoTherapeutics, Inc.
CO: NeoTherapeutics, Inc.
ST: California
IN: MTC HEA
SU: PDT
01/27/99 13:36 EST http://www.prnewswire.com