AGGRASTAT(R) Strategy Trial Data Presented At American Heart Association Annual Meeting

AGGRASTAT(R) Strategy Trial Data Presented At American Heart
Association Annual Meeting
Guilford's Phase III Development Plan Progresses; Enrollment in AGGRASTAT(R)
Phase III TENACITY Trial Begins 


BALTIMORE, Nov. 12  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today announced the presentation of data from the STRATEGY trial
of AGGRASTAT(R) Injection (tirofiban hydrochloride) at the 2004 Scientific
Sessions of the American Heart Association Annual Meeting in New Orleans.  The
study found that a combination of AGGRASTAT(R) and a drug- eluting stent (DES;
Sirolimus eluting stent) resulted in a significantly lower rate of death, MI,
stroke, and binary restenosis at six months, while also providing a similar
cost of care when compared to abciximab used in combination with a bare metal
stent.

Marco Valgimigli, M.D., Chair of Cardiology, University of Ferrara, and
principal investigator for the STRATEGY trial, commented, "The use of GP IIb-
IIIa inhibitor therapy has been the standard of care for patients undergoing
coronary stent procedures.  However, increasing costs have prevented the
adoption of approaches such as DES that have been shown to reduce the incidence
of binary restenosis and target vessel revascularization.  A new, cost-saving
strategy for using DES with a GP IIb-IIIa inhibitor will help us improve
outcomes in the cath lab without increasing costs for the health care system."

"Today's data add to a growing body of evidence regarding the use of
AGGRASTAT(R) both in and outside the cardiac cath lab," commented Craig R.
Smith, M.D., President and Chief Executive Officer of Guilford.  "Including the
results from STRATEGY, eight trials involving more than a thousand patients
have now been completed using the new single high-dose bolus AGGRASTAT(R)
regimen in various clinical settings."

Dr. Smith continued, "Our Phase III clinical development program will employ a
single high-dose bolus regimen of AGGRASTAT(R) followed by a maintenance
infusion in two separate Phase III trials in over 10,000 patients, comparing
AGGRASTAT(R) to current standard of care or placebo.  The first trial to begin,
TENACITY, which has recently started patient enrollment, will evaluate whether
the 30-day efficacy of a single high-dose bolus regimen of AGGRASTAT(R) retains
at least 50% of the treatment benefit of 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 a single high-dose bolus regimen of tirofiban or abciximab."

Guilford plans to conduct a superiority trial outside the United States. The
trial will be 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 2000 patients in 100
centers.  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 cardiac cath laboratory at the time of PCI.

STRATEGY Trial:

High-Dose BoluS TiRofibAn and Sirolimus Eluting STEnt versus Abiciximab and
Bare Metal Stent in Acute MYocardial Infarction (STRATEGY) Study

The six-month study included 175 patients with myocardial infarction who had
persistent ST segment elevation on their electrocardiogram (STEMI) who were
randomized to receive either the single high-dose bolus (SHDB) tirofiban
regimen (N=87; bolus of 25 mcg/Kg/3-min, followed by an infusion of 0.15
mcg/Kg/min for 18-24 h) plus DES, or abciximab (N=88; standard regimen) and
bare metal stent (BMS).

At six months, clinical and angiographic follow-up was conducted in 144
patients. The primary end-point, a composite of death, myocardial infarction
(MI), stroke and binary restenosis rate, occurred in 23% of patients receiving
SHDB tirofiban-DES and 48% of patients receiving abciximab-BMS (p=0.003). There
was also a statistically significant reduction of 6-month MACE for patients
treated with single high-dose bolus tirofiban-DES (15%) compared to those
treated with abciximab-BMS (23%), p=0.04.   There was a trend towards reduction
in all bleeding events for patients treated with SHDB tirofiban-DES compared to
abciximab-BMS (16 patients vs. 9 patients, P=0.3).  Moreover, there was a
significant reduction in thrombocytopenia in patients treated with SHDB
tirofiban-DES versus abciximab-BMS (9 patients versus 1 patients, p=0.03). 
Follow-up for these patients is ongoing.

About GP IIb/IIIa Antagonists

Platelets are blood cells that provide an early defense from the potential
complications of vascular injury.  When a blood vessel is damaged, platelets
adhere to the site and promote blood clot formation.  Clot formation prevents
bleeding and recruits other cells to help heal the damage.  While usually a
beneficial process, these effects can be harmful when a clot forms on a
ruptured lipid plaque within the coronary vasculature.

GP IIb/IIIa antagonists block the ability of platelets to aggregate, inhibiting
clot formation and reducing the potential for cardiac ischemia. Over the last
8-10 years, several large-scale, placebo-controlled clinical trials have
established the efficacy of intravenous GP IIb/IIIa inhibitors for patients
with acute coronary syndrome who are medically managed or go to 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