Guilford Pharmaceuticals Announces Promising Results at ASCO in Study of Newly Diagnosed High Grade Malignant Glioma

Guilford Pharmaceuticals Announces Promising Results at ASCO in
Study of Newly Diagnosed High Grade Malignant Glioma
Study Suggests Safety of GLIADEL(R) Wafer and Temozolomide Used in Combination



BALTIMORE, May 17  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today announced findings from a study of GLIADEL(R) Wafer
(polifeprosan 20 with carmustine) and temozolomide used in combination to treat
adult patients with newly diagnosed high grade malignant glioma.  The data were
presented at the 41st Annual Meeting of the American Society of Clinical
Oncology in Orlando, FL.

Results of the ongoing, Phase II, multi-center, single-arm trial show
acceptable toxicities when combining the two chemotherapeutic agents, and
suggest that the combination may be given safely to patients with initial high
grade malignant glioma.  During the trial, patients underwent surgical
resection followed by implantation of GLIADEL(R), a localized chemotherapy
inserted directly into the resection cavity.  Patients were then treated with
oral daily temozolomide and standard radiotherapy, followed by up to 18 cycles
of oral monthly temozolomide.

"This is a logical follow-up to the work of Stupp et al. (New England Journal
of Medicine, March 10, 2005 Volume 352, No.10)," said Renato V. LaRocca, M.D.,
FACP of Kentuckiana Cancer Institute PLLC and Principal Investigator of the
study.  "GLIADEL(R) and temozolomide are the only FDA- approved treatments
clinically proven to prolong survival in patients with newly diagnosed high
grade malignant glioma.  We are encouraged by the initial results."

The sequential use of the these agents is based on the concept that treatment
with GLIADEL(R) provides local chemotherapy at a time when the residual tumor
cells would be otherwise untreated, prior to the commencement of radiation and
systemic chemotherapy.  A major question has been the safety of combining the
two treatment approaches, and these data begin to address the issue.  Side
effects in the study were similar to those reported in the medical literature
and from previous Phase III trials for each treatment, along with surgical
resection and radiation therapy.

About GLIADEL(R) Wafer

GLIADEL(R) Wafer is the only marketed cancer treatment capable of delivering
chemotherapy directly to the site of a brain tumor, bypassing the blood-brain
barrier and minimizing drug exposure to other areas of the body. GLIADEL(R)
Wafer is a small, white to off-white dime-sized wafer comprised of a
biodegradable polymer (polifeprosan 20) incorporating 7.7 mg. of carmustine
(BCNU), a chemotherapeutic agent usually administered intravenously to treat a
malignant glioma.  Up to eight GLIADEL(R) Wafers can be implanted in the cavity
created when a surgeon removes a brain tumor.  There, they slowly dissolve,
releasing BCNU directly to the tumor site in high concentrations, while
minimizing drug exposure to other areas of the body.  Additional information on
GLIADEL(R) Wafer is available at http://www.gliadel.com/.  For full prescribing
information, please see http://www.guilfordpharm.com/, under Products /
Marketed Products / GLIADEL(R) Wafer.

Important Information About GLIADEL(R) Wafer

GLIADEL(R) Wafer is indicated in newly diagnosed patients with high-grade
malignant glioma as an adjunct to surgery and radiation.  GLIADEL(R) Wafer is
also indicated in recurrent glioblastoma multiforme patients as an adjunct to
surgery.

The following four categories of adverse events are possibly related to
treatment with GLIADEL(R) Wafer during initial resection.  Frequencies are
listed of events that occurred in a randomized trial of GLIADEL(R) Wafer and
placebo, respectively: seizure (33.3% vs 37.5%); brain edema (22.5% and 19.2%);
healing abnormalities (15.8% vs 11.7%); and intracranial infection (5.0% vs
6.0%).  The following three categories of adverse events are possibly related
to treatment with GLIADEL(R) Wafer for recurrent disease.  Frequencies are
listed of events that occurred in a randomized trial of GLIADEL(R) Wafer and
placebo, respectively: post-operative seizure (19% vs 19%); healing
abnormalities (14% vs 5%); intracranial hypertension (4% vs 6%) and
intracranial infection (4% vs 1%).

Patients undergoing craniotomy for malignant glioma and implantation of
GLIADEL(R) Wafer should be monitored closely for known complications of
craniotomy, including seizures, intracranial infections, abnormal wound
healing, and brain edema.  Cases of intracerebral mass effect unresponsive to
corticosteroids have been described in patients treated with GLIADEL(R) Wafer,
including one case leading to brain herniation.  GLIADEL(R) Wafer contains
carmustine and should not be given to patients who are allergic to carmustine.
Carmustine can also cause fetal harm when administered to a pregnant woman. The
short and long-term toxicity profiles of GLIADEL(R) Wafer when given in
conjunction with radiation or chemotherapy have not been fully explored.

About Guilford

Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the
research, development and commercialization of proprietary drugs that target
the hospital and neurology markets.  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 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 peripheral nerve injury.  For additional prescribing
information about GLIADEL(R) and AGGRASTAT(R) please see
http://www.guilfordpharm.com/, under Products / Marketed Products.

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
May 9, 2005 that could cause the Company's actual results and experience to
differ materially from anticipated results and expectations expressed in these
forward-looking statements.

   Contact:
   Media Relations
   Ellie Kline
   Ph. 202-944-5193
   

DATASOURCE: Guilford Pharmaceuticals Inc.



CONTACT:  Ellie Kline, Media Relations, [phone],

, for Guilford Pharmaceuticals



Web site:  http://www.guilfordpharm.com/

http://www.gliadel.com/ 



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