Guilford Pharmaceuticals: AGGRASTAT(R) Injection Clinical Data Presented at American College of Cardiology Annual Meeting

Guilford Pharmaceuticals: AGGRASTAT(R) Injection Clinical Data
Presented at American College of Cardiology Annual Meeting 


BALTIMORE, March 8  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today announced the presentation of additional data from the
ADVANCE trial (The Additive Value of Tirofiban Administered With the High-Dose
Bolus in the Prevention of Ischemic Complications During High-Risk Coronary
Artery Angioplasty) at the 2005 Scientific Sessions of the American College of
Cardiology Annual Meeting in Orlando.  The data presented today by Dr. Marco
Valgimigli showed that in this study a single high dose bolus (SHDB) regimen of
AGGRASTAT(R) Injection (tirofiban hydrochloride) improved outcomes in diabetic
patients undergoing percutaneous coronary intervention (PCI) when compared to
placebo.

AGGRASTAT(R), in combination with heparin and aspirin, is indicated for the
treatment of acute coronary syndrome (ACS) including patients who are to be
managed medically and those undergoing PTCA or atherectomy.

Marco Valgimigli, M.D., Chair of Cardiology, University of Ferrara, Italy, and
principal investigator for the ADVANCE trial, commented, "Diabetic patients are
known to experience a higher rate of adverse ischemic events during and after
PCI.  One hypothesis is that this is a result of the differences in platelet
physiology between diabetic and non-diabetic patients. Diabetic platelets are
larger and demonstrate enhanced aggregation compared to non-diabetic platelets.
 We sought to determine whether AGGRASTAT(R), administered as a SHDB regimen
could reduce ischemic events in diabetic patients referred for elective or
urgent PCI."

ADVANCE Methodology and Results:

The ADVANCE study was a double-blind, placebo-controlled, randomized trial that
included 202 high-risk patients undergoing PCI.  Patients in the placebo group
were eligible to receive bail-out GP IIb/IIIa inhibitor therapy during PCI if
deemed necessary by the investigator.  In this PCI trial, 98% of patients
underwent intracoronary stenting.

The data presented today were based on a prespecified subgroup analysis of 99
patients with diabetes who participated in the ADVANCE trial.  On background
therapy of heparin, aspirin and a thienopyridine (ticlopidine or clopidogrel),
patients were randomized to receive the SHDB regimen of AGGRASTAT(R) (N=54;
bolus of 25 mcg/Kg/3-min, followed by an infusion of 0.15 mcg/Kg/min for 24-48
h), or placebo (N=45).  The primary endpoint was a composite of death, nonfatal
myocardial infarction (MI), urgent target vessel revascularization and
thrombotic bailout GP IIb/IIIa inhibitor therapy occurring within six months of
PCI.

After a median follow-up of 262 days (range: 143-398) the results yielded a
significantly reduced primary composite endpoint with the SHDB regimen of
AGGRASTAT(R) when compared to placebo (17% vs. 40%; HR 0.37 [95% CI: 0.11-
0.58]; p=0.003), with a relative risk reduction of 58%.  The incidence of major
and minor bleeding was not statistically different between the two groups. 
However, this lack of difference in adverse events could be due to the fact
that the study was underpowered.  The difference in the incidence of adverse
ischemic events was mainly due to a lower rate of periprocedural MI in the
AGGRASTAT(R) versus the placebo group (4% vs. 18%, p=0.048).

In this study, the Investigators concluded that "the SHDB regimen of
AGGRASTAT(R), by decreasing the incidence of ischemic complications, was both
safe and effective, supporting the notion that diabetic patients, irrespective
of their clinical status, would probably benefit from a tailored drug regimen
during PCI."  These findings were based on a limited and selected sample size,
and thus should be viewed as preliminary.

Important Information About AGGRASTAT(R) Injection

AGGRASTAT(R) Injection (tirofiban hydrochloride) 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) 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