I visited Neotheraputics, Inc. in October to introduce the company to the
Parkinson's Pipeline Project (aka Parkinson's FDA Industry Initiative--- see
www.parkinsonscare.org/RxDev.html). I met with the Scientific Director and the
Medical Director. The company is focusing its efforts on a 'pivotal' phase II
Alzheimers clinical trial of neotrofin. The results are expected in the first
quarter of 2002. With no products on the market, the company is under some
pressure from investors. Preliminary imaging studies on humans taking the
medication done at UC-Irvin have had promising results.
A pilot study is being conducted in 5 centers for PD. As of a month ago 17/25
subjects for the pilot had been enrolled. They are looking for newly diagnosed
patients only for the pilot. The trial is 3 months (maybe too short) and results
are expected in the spring. (see press release below)
Neotrofin is one of several nerve growth factors already being tested by
pharmaceutical companies and soon to be studied by NIH in a large clinical
trial. Neuroimmunophilin Ligands (NIL) now under Guilford Pharmaceuticals are
farther down the pipeline, but had disappointing results in recent trials by
Amgen and have been delayed by the transition from Amgen back to Guilford. Both
of these medications have the advantage of being small molecules that cross the
blood-brain barrier and can be taken orally but as I understand it different
mechanism are at work. NIL stimulates the growth of nerve endings, while
Neotrofin stimulates stem cells in the brain to regenerate nerve growth. (please
correct me if I am wrong in this over simplified characterization).
********************
IRVINE, Calif., Aug. 23 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT;
NEOTW)
announced today that it has expanded its Neotrofin phase 2 Parkinson's disease
trial to include four additional clinical locations. New participants include
Memorial Hospital of Rhode Island (Providence), Rush Presbyterian-St. Luke's
Medical Center (Chicago), The Parkinson's Institute (Sunnyvale, CA), and Oregon
Health & Science University (Portland). Ten patients are currently receiving
either Neotrofin or placebo, including seven patients at the Parkinson's and
Movement Disorder Institute at Long Beach Memorial Hospital.
``Neotrofin uses the body's own tools to protect, repair and rebuild nerves in
the brain,'' stated Rajesh C. Shrotriya, M.D., President and Chief Operating
Officer of NeoTherapeutics. ``Our drug activates nerve growth factors, which in
addition to helping repair nerves, cause the proliferation of stem cells that
already exist in the brain. Additional growth factors stimulated by Neotrofin
may then cause the differentiation and maturation of these new stem cells into
new neurons, which could repair the damage done by neurodegenerative conditions
such as Parkinson's disease.''
Patients participating in this trial will receive doses of Neotrofin escalating
from 250 mg to 1,000 mg twice per day for twelve weeks. In addition to extensive
assessments of tolerance and safety, the Unified Parkinson's Disease Rating
Scale (UPDRS)-part III (Motor Scale) will be used as the primary measure of
preliminary efficacy. Several other Parkinson's disease rating scales will be
used as secondary efficacy measures.
*********************************
Perry Cohen
www.parkinsonscare.org
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