Guilford Pharmaceuticals Presents New GLIADEL(R) Wafer Data at the Society for Neuro-Oncology Annual Meeting

Guilford Pharmaceuticals Presents New GLIADEL(R) Wafer Data at
the Society for Neuro-Oncology Annual Meeting 


BALTIMORE, Nov. 22  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today announced that new data for GLIADEL(R) Wafer (polifeprosan
20 with carmustine implant) were presented on Saturday, November 20th at the
Society for Neuro-Oncology (SNO) Annual Meeting in Toronto, Canada.  The
Society for Neuro-Oncology is regarded as the preeminent scientific society for
clinical research on brain cancer.  The data, which are part of a three-year,
prospective patient registry called PROLONG(R), suggest that GLIADEL(R) may be
useful in controlling local disease progression in patients with metastatic
brain cancer.  The frequency of metastatic brain cancer has increased in recent
years and is estimated to occur in up to 40% of patients diagnosed with cancer.

PROLONG(R), or Prospective Look at Outcomes Nationally with GLIADEL(R) Wafer,
is a patient registry designed to capture prospective, observational data on
the use of GLIADEL(R) in real-world clinical practice for the purpose of
enhancing best practices in the management of brain cancer in patients
receiving GLIADEL(R) as part of a multi-modal treatment regimen.  Data in the
PROLONG(R) registry were collected prospectively from December 2001 until
December 2003.  During this period a total of 322 patients were enrolled in the
registry, beginning at the time of their first post-operative visit.  They were
then followed at 3-month intervals until death or loss to follow-up.

The data presented at the Society for Neuro-Oncology annual meeting reported
the results of a prospective analysis of 30 patients with metastatic brain
cancer (representing 11% of the patients in the registry) who received therapy
with GLIADEL(R) in addition to surgical resection and other therapies. After a
median follow-up period of 27 weeks, 9 patients had died and disease
progression was reported in 8 patients.  Of the patients who experienced a
recurrence, the data show that there was no evidence of local recurrence at the
tumor resection site, while 7 patients experienced distal recurrence in the
central nervous system.  The recurrence location for 1 patient was unavailable.

Dr. Matthew Meldorf, Senior Director of Medical Affairs for Guilford,
commented, "So far, there has been very little published data describing the
use of GLIADEL(R) in patients with metastatic brain cancer.  The data from the
PROLONG(R) registry reveal low local rates of disease recurrence when
GLIADEL(R) is employed along with other therapies, suggesting a role for
GLIADEL(R) in the management of metastatic disease.  Two additional published
studies provide further evidence of low local recurrence rates when GLIADEL is
used in combination with initial surgical resection of CNS metastases and other
therapies, however, randomized, controlled clinical trials are needed to
confirm these findings before any conclusions about efficacy can be drawn."

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% vs.
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.

   Contact:  Guilford Pharmaceuticals Inc.
             Stacey Jurchison 410.631.5022



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
November 8, 2004, that could cause the Company's actual results and experience
to differ materially from anticipated results and expectations expressed in
these forward-looking statements. 

DATASOURCE: Guilford Pharmaceuticals Inc.



CONTACT:  Stacey Jurchison, Guilford Pharmaceuticals Inc.,

[phone]



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

http://www.gliadel.com/ 



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