AGGRASTAT(R) Injection Strategy Trial Data Published in JAMA

AGGRASTAT(R) Injection Strategy Trial Data Published in JAMA



BALTIMORE, May 11  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today announced the publication of results from the STRATEGY
trial of AGGRASTAT(R) Injection (tirofiban hydrochloride) in the Journal of the
American Medical Association, (May 2005 - Vol. 293, No. 17 pgs. 2109 - 2117). 
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,
myocardial infarction, stroke, and binary restenosis at eight months for
patients with ST-elevation myocardial infarction (STEMI), 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, "Our results
demonstrate that tirofiban in combination with a drug-eluting stent (sirolimus
eluting stent (SES)) during primary percutaneous coronary intervention resulted
in improved clinical and angiographic outcomes relative to a strategy of
abciximab in combination with a bare metal stent.  Moreover, there was a
statistically significant reduction in the incidence of thrombocytopenia for
patients receiving tirofiban and sirolimus eluting stent versus abciximab plus
bare metal stent and a trend toward lower bleeding rates for patients treated
with tirofiban and DES.  Additional large scale trials, like TENACITY and
MULTI-STRATEGY, will be needed to further evaluate the new single high-dose
bolus (SHDB) regimen of tirofiban for these patients."

Dr. Valgimigli continued, "In addition to clinical and angiographic data, we
have confirmed that the SHDB regimen of tirofiban yields similar levels of
platelet inhibition to that achieved with abciximab even in particularly high-
risk patients such as those presenting with STEMI."

STRATEGY Trial:

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

The eight-month study included 175 patients with persistent ST segment
elevation myocardial infarction (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 SES,
or abciximab (N=88; bolus of 0.25 mg/kg/3-min, followed by a 12-hour infusion
of 0.125 mcg/Kg per minute) and bare metal stent (BMS).

At eight months, clinical and angiographic follow-up was conducted in 175
patients.  The primary end-point, a composite of death, myocardial infarction
(MI), stroke and binary restenosis rate at eight months, occurred in 18% of
patients receiving SHDB tirofiban-DES and 32% of patients receiving
abciximab-BMS (HR, 0.53; 95% CI, 0.28 - 0.92; p=0.04).  Overall, the composite
of death or reinfarction was similar in the tirofiban plus sirolimus eluting
stent group (13%) versus the abciximab plus bare metal stent group (17%) (HR,
0.71; 95% CI, 0.34-1.5; p=0.39), while there was a significant reduction in the
need for TVR (7% versus 20% respectively; HR, 0.30; 95% CI, 0.12-0.77; p=0.01)
in the tirofiban plus SES group.  There was also a trend towards reduction in
all bleeding events for patients treated with SHDB tirofiban-SES compared to
abciximab-BMS.  Moreover, there was a statistically significant reduction in
thrombocytopenia in patients treated with SHDB tirofiban-SES versus
abciximab-BMS (1 patient versus 9 patients, p=0.03).

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