PRESS RELEASE: NIH Begins Phase II Clinical Testing of Guilford Pharmaceuticals' GPI 1485 for Parkinson's Disease.

[Murray Charters <mcharters@xxxxxxxxxxxxxx>]

PRESS RELEASE: NIH Begins Phase II Clinical Testing of Guilford 
Pharmaceuticals' GPI 1485 for Parkinson's Disease.

BALTIMORE, Feb 23, 2004 /PRNewswire-FirstCall via COMTEX/ -- Guilford 
Pharmaceuticals Inc. (Nasdaq: GLFD) announced
today that the National Institutes of Health (NIH) has initiated a Phase II 
clinical trial to test the Company's
neuroimmunophilin ligand, GPI 1485, as part of a comprehensive program 
investigating novel neuroprotective therapies
for Parkinson's disease. The NIH program is currently studying four promising 
investigational therapies, including GPI
1485. The study is being funded by the National Institute of Neurological 
Disorders and Stroke (NINDS), a division of
the NIH. It will be carried out in cooperation with the Clinical Trials 
Coordinating Center at the University of
Rochester and the Statistical Coordinating Center at Medical University of 
South Carolina and over 50 participating
clinical sites in the United States and Canada. Bernard Ravina, M.D., is the 
Program Director for the trial at the
Clinical Trials group of NINDS.

The NINDS selected GPI 1485 based upon strong, consistent preclinical data in 
animals and encouraging preliminary data
from early human clinical testing. The research team has begun patient 
enrollment, and results of the trial are
expected in the second half of 2005. Compounds that demonstrate neuroprotection 
in the Phase II program may be entered
into Phase III studies.

Craig R. Smith, M.D., Chairman, President and Chief Executive Officer of 
Guilford, remarked, "Including the NIH study,
there are currently three ongoing Phase II clinical trials of GPI 1485, 
including two protocols in Parkinson's disease
and a separate study evaluating GPI 1485 for the treatment of 
post-prostatectomy erectile dysfunction. The scope of
these trials will give us the opportunity to more comprehensively assess the 
therapeutic effects of GPI 1485, in which
earlier testing has suggested its ability to retard the loss of dopamine 
transporters, a marker of disease progression,
in patients with Parkinson's disease."

Dr. Ravina commented, "Parkinson's disease is a chronic, progressive, 
debilitating disorder which presently affects
approximately one million Americans. Existing therapies focus only on 
controlling or minimizing the symptoms of the
disease. NINDS intends to pursue novel treatment options focusing on 
neuroprotective therapies that may be able to slow
disease progression. We believe that this important collaborative effort will 
help elucidate new and better potential
treatments for the benefit of patients with Parkinson's disease."

About the NIH Clinical Trial Program in Parkinson's Disease

The Phase II trial is currently recruiting and will enroll 195 patients who are 
newly diagnosed with Parkinson's
disease and are not taking anti- symptomatic medications, such as levodopa or 
dopamine agonists, for their disease.
Patients in the trial will be randomized into one of three groups and receive 
either treatment with GPI 1485, treatment
with another agent, or placebo. In all, over 50 sites are planned and 
enrollment is expected to take up to six months
to complete. The treatment duration will be 12 months. For more information 
about the trial visit
www.clinicaltrials.gov, or call 1-800-352-9424.

The primary outcome measure will be change in the total Unified Parkinson 
Disease Rating Scale (UPDRS) between either
(1) baseline and 12 months, or (2) baseline and the time of sufficient 
disability to require symptomatic therapy. That
is, if a patient completes the 12-month treatment period without requiring the 
addition of symptomatic medication such
as levodopa or a dopamine agonist, the endpoint for that patient will be the 
change from baseline to 12 months.
Alternatively, if a patient's condition worsens enough to require symptomatic 
therapy, the outcome measure for that
patient will be the change from baseline to the last visit before starting 
medication, thus avoiding the confounding
effect of symptomatic therapy on UPDRS.

Guilford will be responsible for supplying active drug and placebo for the 
study. If the results of the initial pilot
study of GPI 1485 appear promising, NINDS may consider conducting Phase III 
clinical testing of GPI 1485. All financial
and other obligations related to the conduct of the studies will be supported 
by NINDS. Further, NINDS and its
investigators will provide Guilford access to data from the study, and will 
cooperate with Guilford in meeting Food and
Drug Administration (FDA) requirements for submission of the results of the 
trial as part of a broader filing should
this occur.

About GPI 1485 and Neuroimmunophilin Ligands

GPI 1485 is an investigational new drug that belongs to a class of small 
molecule compounds called neuroimmunophilin
ligands. In preclinical experiments, neuroimmunophilin ligands have been shown 
to repair and regenerate damaged nerves
without affecting normal, healthy nerves. Neuroimmunophilin ligands may have 
application in the treatment of a broad
range of diseases, including: Parkinson's disease, spinal cord injury, brain 
trauma, and peripheral nerve injuries
including post-prostatectomy erectile dysfunction.

About Parkinson's Disease

Parkinson's disease is a chronic, progressive degenerative disorder that 
involves a specialized region of the brain
that controls muscle tone and coordination and affects over one million people 
in the United States. Most patients are
affected in mid-life and usually develop hand tremors, muscle rigidity, and 
postural instability, among the many
manifestations of the disease. The disease is caused by the degeneration of 
nerve cells that use dopamine as a chemical
messenger. Treatment currently consists of administering drugs that increase 
the amount of dopamine in the affected
regions of the brain or substitute for the lost dopamine. Unfortunately, there 
are no current treatments that can
reverse, or even slow down, the progressive degeneration of the affected 
dopamine nerve cells.

About Guilford

Guilford Pharmaceuticals Inc. is a fully integrated pharmaceutical company 
engaged in the research, development and
commercialization of products that target the hospital market. Presently, 
Guilford markets two commercial products,
GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), for the treatment 
of brain cancer, and AGGRASTAT(R)
Injection (tirofiban hydrochloride), a glycoprotein GP IIb/IIIa receptor 
antagonist used for the treatment of acute
coronary syndrome (ACS). Guilford's product pipeline includes a novel 
anesthetic, AQUAVAN(R) Injection, and drugs for
treating Parkinson's disease and post-prostatectomy erectile dysfunction.

This press release contains forward-looking statements that involve risks and 
uncertainties, including those described
in the section entitled "Risk Factors" contained in the Company's quarterly 
report on Form 10-Q filed with the SEC on
November 12, 2003, that could cause the Company's actual results and experience 
to differ materially from anticipated
results and expectations expressed in these forward-looking statements. Among 
other things, there can be no assurance
that the NIH clinical trial will be completed or the endpoint will be met, or 
that NIH will conduct a Phase III trial.
In addition, there can be no assurance GPI 1485 will ultimately be approved for 
commercial use by the Food and Drug
Administration

CONTACT:

Stacey Jurchison,
Director, Corporate Communications,
Guilford Pharmaceuticals,
(410) 631-5022;
jurchisons@xxxxxxxxxxxxxxxxx


SOURCE Guilford Pharmaceuticals Inc.

CONTACT:

Stacey Jurchison,
Director, Corporate Communications,
Guilford Pharmaceuticals,
+1-410-631-5022,
jurchisons@xxxxxxxxxxxxxxxxx

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SOURCE: PR Newswire / Comtex / Macro*World Investor


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