Something like this might help test for neuroprotective effects of various
treatments.
Ron Reiner (49/2)
---------------------
Guilford Pharmaceuticals and
Parkinson Study Group Announce
Positive Clinical Results With
DOPASCAN(R), Parkinson`s
Disease Diagnostic Agent
June 10, 1997
BALTIMORE, June 9 /PRNewswire/ via Individual Inc. -- Guilford
Pharmaceuticals Inc. (Nasdaq: GLFD) today announced that the
analysis of a Phase IIB multi-center clinical study of
DOPASCAN(R) Injection has been completed and demonstrated
positive results. Based on the findings, the Company is moving
ahead with plans to conduct Phase III clinical trials.
DOPASCAN(R) is the first diagnostic test being developed for
Parkinson's disease, a common neurodegenerative disorder. The
signs and symptoms of Parkinson's disease result from the
deterioration of dopamine neurons in the brain. DOPASCAN(R) is
a radiopharmaceutical which is administered by injection and
allows physicians to obtain pictures of dopamine neurons with
conventional brain scanning equipment. The pictures obtained
with DOPASCAN(R) measure the deterioration of dopamine
neurons and can be used to diagnose Parkinson's disease.
The completed Phase II study was the first multi-center clinical
trial conducted with DOPASCAN(R). It was designed to
investigate the use of DOPASCAN(R) and SPECT imaging in the
diagnosis of Parkinson's disease in a patient population that
included: patients previously diagnosed with Parkinson's disease;
patients diagnosed with essential tremor, a movement disorder
not related to Parkinson's disease; progressive supranuclear palsy
(PSP), a disease closely resembling Parkinson's disease clinically
but which does not respond to treatment for Parkinson's disease;
and a control group of healthy individuals. A total of 96 patients
were studied.
The results from the Phase IIB study indicate that DOPASCAN(R)
can differentiate subjects with a Parkinsonian disorder
(Parkinson's disease and PSP) from subjects without a
Parkinsonian disorder (essential tremor and healthy controls) with
a high sensitivity (98%) and specificity (97%). No serious adverse
events were attributed to DOPASCAN(R) in this study.
A comprehensive analysis of the results of the study is expected
to be presented September 28, 1997 at The Parkinson Study
Group/Movement Disorders symposium which will be held in
conjunction with the meeting of the American Neurological
Association.
"The early diagnosis of Parkinson's disease can be complicated,
expensive, and time consuming. The results we have obtained
with DOPASCAN(R) are very encouraging. We believe a new,
rapid diagnostic test that can identify Parkinson's disease would
be valuable to patients and their physicians, and make possible
more effective and appropriate treatments. We hope to begin our
Phase III clinical trials with DOPASCAN(R) after consultation
with the FDA," commented Dr. Craig R. Smith, President and CEO
of Guilford Pharmaceuticals Inc.
Guilford Pharmaceuticals Inc. is a biopharmaceutical company
engaged in the development of polymer-based therapeutics for
cancer, and novel products for the diagnosis and treatment of
neurological diseases, including Parkinson's disease, Alzheimer's
disease, stroke, severe head trauma, spinal cord injuries, multiple
sclerosis, peripheral neuropathies, and cocaine addiction.
This press release contains forward-looking statements that
involve risk and uncertainties, including those described in the
section entitled "Risk Factors" from the Company's registration
statement on Form S-3, declared effective April 7, 1997, that could
cause the Company's actual results and experience to differ
materially from anticipated results and expectations expressed in
these forward-looking statements. In particular, the clinical results
discussed above are based on a limited number of patients, the
Company's plan to begin Phase III clinical trials is dependent
upon several factors beyond the Company's control such as
receipt of FDA clearance to proceed to Phase III and the timely
delivery of a Phase III scale-up process by the Company's
supplier of DOPASCAN(R), and there can be no assurance that
delays may not occur in the Company's current plans, that the
Company will be able to successfully develop DOPASCAN(R)
into a safe and effective FDA-cleared drug or that it can be
successfully marketed and commercialized even if FDA marketing
clearance is eventually obtained.
Internet address: http://www.guilfordpharm.com
For Press Releases: http://www.prnewswire.com
SOURCE Guilford Pharmaceuticals Inc.
/CONTACT: Angela Webber of Guilford Pharmaceuticals,
410-631-6449; media, Brad Miles of B.M.C., or for investors,
Jonathan Fassberg of The Trout Group, 212-477-9007/ (GLFD)
[Copyright 1997, PR Newswire]
