NeoTherapeutics initiates Neotrofin(tm) spinal cord injury trial at Rancho
Los Amigos Hospital
A phase 2 study in paraplegic and quadriplegic spinal cord injury patients
set to begin enrollment
IRVINE, Calif., March 26, 2001 -- NeoTherapeutics, Inc. (NASDAQ: NEOT;
NEOTW) announced today that it has initiated a 12 week open-label pilot
study of Neotrofin in patients with subacute, complete spinal cord injury.
The study has begun at Rancho Los Amigos Hospital in Los Angeles County,
California, under the direction of principal investigator Robert Waters,
M.D. Initially, ten patients are planned to be enrolled at Rancho Los
Amigos Hospital, which is one of sixteen centers of excellence for spinal
cord injury in the United States. This is the largest rehabilitation center
in the Western United States. It provides training for residents from the
University of Southern California (USC) School of Medicine, the University
of California, Los Angeles (UCLA) School of Medicine, the University of
California, Irvine (UCI) School of Medicine, Western University and the
University of Hawaii.
Patients will receive Neotrofin for 12 weeks, and will be evaluated at
regular intervals. In addition to extensive assessments for tolerance and
safety, the Standard Neurological Classification of Spinal Cord Injury
(SNCSCI) - manual motor exam score will be used as the primary evidence of
preliminary efficacy. Secondary efficacy measures include: American Spinal
Injury Association (ASIA) impairment scale (ASIA-IS), Functional
Independence Measure (FIM) and SNCSCI-sensory exam. Eligible participants
will begin treatment 7 to 21 days post injury, and must be stable medically.
Commenting on the new trial, Stephen W. Jenkins, M.D., a board-certified
neurologist and medical monitor for NeoTherapeutics stated, "We begin this
study with hope that the improvements that Neotrofin has demonstrated in
animal models of spinal cord injury will eventually be seen in patients.
This is the Company's first human trial of Neotrofin in spinal cord injury,
and we will be looking for confirmation of the excellent safety profile that
has been seen in the over 1,100 patients who have taken Neotrofin in
Alzheimer's disease clinical trials. In addition, this study is designed to
provide preliminary evidence of efficacy. Based on the safety and
preliminary efficacy data from this study, we may escalate dosing and/or
expand into larger/longer efficacy trials."
"Spinal cord injury is a devastating condition that involves largely young
males under thirty-two years of age, who are left maimed for life, and there
is currently no drug on the market to provide relief to the victims", stated
Rajesh Shrotriya, M.D., President of NeoTherapeutics. "We sincerely hope
that this trial will be the first step in providing spinal cord injured
individuals some hope, and provide us with some insights into the
appropriate study design for subsequent larger clinical trials."
The Christopher Reeve Paralysis Foundation estimates that there are
approximately 250,000 spinal cord injured individuals (SCI) living in the
United States. Sixty percent are first affected between 16 and 30 years of
age, and ninety percent of SCI individuals survive and have near normal life
spans. There are approximately 10,000 new spinal cord injury cases per
year. Initial hospitalization lasts 100 days on average, and lifetime costs
for individuals with SCI average $600,000. Current clinical practice
recommends the early use of high doses of methylprednisolone for 24 to 48
hours after injury, but the effects of this treatment are limited. New
therapies for those currently burdened by SCI and prevention of new injuries
could save as much as $400 billion.
NeoTherapeutics is a biopharmaceutical company focused on the development of
drugs for unmet medical needs. The Company's most advanced drug,
Neotrofin(tm), is currently being developed for Alzheimer's disease and
other neurodegenerative diseases, such as Parkinson's disease and spinal
cord injury. NeoGene Technologies, Inc., a subsidiary of NeoTherapeutics,
is engaged in functional genomics research. A second subsidiary, NeoOncoRx,
Inc., is engaged in the development of anti-cancer drugs. For additional
Company information, visit NeoTherapeutics' web site at .
This press release may contain 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 are described in further detail in the Company's reports filed with
the Securities and Exchange Commission. |
