Guilford Pharmaceuticals Announces Plans to Initiate Two Major Clinical Trials Evaluating AGGRASTAT(R) Injection in Percutaneous

Guilford Pharmaceuticals Announces Plans to Initiate Two Major
Clinical Trials Evaluating AGGRASTAT(R) Injection in Percutaneous Coronary
Intervention 


BALTIMORE, Aug. 12  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today announced plans to launch two major trials for AGGRASTAT(R)
Injection (tirofiban hydrochloride), that are designed to determine the optimal
therapeutic regimen for patients at the time of percutaneous coronary
intervention (PCI).

Guilford plans to conduct the first trial outside the United States as a
multi-center, double-blind, placebo-controlled trial evaluating the 30-day
efficacy of the single high-dose bolus regimen of AGGRASTAT(R) compared to
placebo in high-risk patients undergoing PCI with coronary stent placement. The
trial is expected to enroll approximately 2,000 patients in 100 centers.
According to present plans, all patients will receive background treatment
including heparin, aspirin and clopidogrel (Plavix(R)), if not contraindicated.
 The results of this trial are expected to provide a basis for seeking FDA
approval to expand the present indication of AGGRASTAT(R) to include a new
dosing regimen for treatment with AGGRASTAT(R) in the catheterization
laboratory at the time of PCI.  Guilford will be meeting with the FDA to
discuss the details of its design and its appropriateness for securing an
expanded label.

Under the current trial design, investigators will employ a single high- dose
bolus of 25 mcg/kg followed by a 0.15 mcg/kg/min tirofiban infusion. This
dosing regimen has been utilized in 520 patients enrolled in 6 clinical trials,
including the ADVANCE trial, recently published in the Journal of the American
College of Cardiology.  Results from this trial demonstrated a significantly
reduced primary composite end point (death, nonfatal MI, urgent TVR, and
bailout GP IIb/IIIa inhibitor therapy during follow-up) with heparin plus
tirofiban over heparin plus placebo.  Minor bleeding was observed in both the
tirofiban and placebo arms; the difference between the two was not
statistically significant (p=0.19).  There was no severe thrombocytopenia in
either treatment arm, and one patient in each treatment arm had mild
thrombocytopenia.

"We know the current labeled dosing regimen of AGGRASTAT(R) provides
therapeutic value when administered early, prior to acute coronary syndrome
patients getting to the cath lab," explains David Moliterno, M.D. and principal
investigator in the TENACITY trial.  "We believe this single high- dose bolus
administered at the time of PCI will increase AGGRASTAT(R)'s therapeutic value
and versatility while preserving safety."

The second study, TENACITY ("Tirofiban Novel Dosing vs. Abciximab with
Evaluation of Clopidogrel and Inhibition of Thrombin Study") will be a multi-
center, double blind, randomized comparison of AGGRASTAT(R) and ReoPro(R)
(abciximab) that is expected to enroll at least 8,000 patients in approximately
200 centers across the United States.  The Cleveland Clinic Cardiovascular
Coordinating Center (C5) and Duke Clinical Research Institute (DCRI) will
coordinate the trial.  The primary objective is to determine whether the 30-day
efficacy of a single high-dose bolus regimen of AGGRASTAT(R) is non-inferior to
abciximab in patients undergoing PCI with coronary stent placement.  In
addition, TENACITY will, for the first time, evaluate the 30-day safety and
efficacy of bivalirudin (Angiomax(R)) versus heparin with tirofiban or
abciximab.  If successful, TENACITY is expected to advance medical practice in
the field of interventional cardiology by defining the role of AGGRASTAT(R) in
combination with other anti-platelet and anti- thrombotic agents in this
patient population.

"TENACITY will be a head-to-head comparison of AGGRASTAT(R) against what most
interventional cardiologists perceive as the 'gold standard' GP IIb/IIIa
inhibitor for use at the time of PCI," explains trial chairman, Eric Topol,
M.D.  He continues, "The novel design of TENACITY will help clarify how GP
IIb/IIIa inhibitors can be optimally used with other anti-platelet and anti-
thrombotic agents.  In many ways, it is the trial the interventional cardiology
community has been waiting to conduct."

Craig R. Smith, M.D., Guilford's President and CEO commented, "We are investing
in these trials because we are fully committed to providing physicians with the
information they need to optimize patient care.  Approved labeling in this
market would create a significant opportunity for AGGRASTAT(R) since the
majority of the $550 million GP IIb/IIIa U.S. market is within the cath lab."

Important Information About AGGRASTAT(R) Injection

AGGRASTAT(R) was approved by the Food and Drug Administration (FDA) on May 14,
1998.  AGGRASTAT(R), in combination with heparin, and aspirin, if not
contraindicated, is indicated for the treatment of ACS including patients who
are to be managed medically and those undergoing PTCA or atherectomy.  In this
setting, AGGRASTAT(R) has been shown to decrease the rate of a combined
endpoint of death, new myocardial infarction or refractory ischemia/repeat
cardiac procedure.  In most patients, AGGRASTAT(R) should be administered
intravenously, at an initial rate of 0.4 mcg/kg/min for 30 minutes and then
continued at 0.1 mcg/kg/min.  For complete information, please refer to the
product's prescribing information.

AGGRASTAT(R) (tirofiban hydrochloride) is contraindicated in patients with
known hypersensitivity to any component of the product; active internal
bleeding or a history of bleeding diathesis within the previous 30 days; or a
history of intracranial hemorrhage, intracranial neoplasm, arteriovenous
malformation, or aneurysm.  Other contraindications to AGGRASTAT(R) include: a
history of thrombocytopenia following prior exposure to AGGRASTAT(R); history
of stroke within 30 days or any history of hemorrhagic stroke; major surgical
procedure or severe physical trauma within the previous month; or history,
symptoms, or findings suggestive of aortic dissection.  AGGRASTAT(R) is also
contraindicated in patients with: severe hypertension (systolic blood pressure
>180 mmHg and/or diastolic blood pressure >110 mmHg); concomitant use of
another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.

Bleeding is the most common complication encountered during therapy with
AGGRASTAT(R).  Administration of AGGRASTAT(R) is associated with an increase in
bleeding events classified as both major and minor bleeding events, by criteria
developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). 
Most major bleeding associated with AGGRASTAT(R) occurs at the arterial access
site for cardiac catheterization.  Fatal bleedings have been reported. 
AGGRASTAT(R) should be used with caution in patients with platelet count