National Brain Tumor Awareness Week 2001 Innovative Wafer Therapy Has Enhanced Treatment Options, Renewed Hope
(PR Newswire)This year more than 185,000 Americans will be diagnosed with primary or metastatic brain tumors, now the leading cause of solid tumor cancer death in children younger than age 20, and the third leading cause of cancer death in young adults between the ages of 20 to 39.- May 07 8:32 AM ET
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Posted on: 05/07/2001
"Yahoo - National Brain Tumor Awareness Week 2001; Innovative Wafer Therapy Has Enhanced Treatment Options, Renewed Hope"
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Guilford Pharmaceuticals, Inc.
National Brain Tumor Awareness Week 2001; Innovative Wafer Therapy Has Enhanced Treatment Options, Renewed Hope
BALTIMORE, May 7 /PRNewswire/ -- This year more than 185,000 Americans
will be diagnosed with primary or metastatic brain tumors, now the leading
cause of solid tumor cancer death in children younger than age 20, and the
third leading cause of cancer death in young adults between the ages of 20 to
However, hope exists in battling this devastating disease, thanks to
revolutionary drug therapies that may prolong patient survival and improve the
quality of each day for patients.
In an effort to raise awareness of the most promising treatments for brain
tumors, and to encourage further clinical research and funding, the North
American Brain Tumor Coalition (NABTC) has set aside this week, May 6-12, as
National Brain Tumor Awareness Week.
Previously not one of the most well
known types of cancer, brain cancer is becoming nationally recognized through
the help of grassroots awareness campaigns, patient advocacy and the NABTC's
lobbying efforts to bolster research funding.
Among the most promising treatments for recurrent glioblastoma multiforme
(GBM) -- the most rapidly progressive and fatal of all brain tumors -- is
GLIADEL® Wafer (polifeprosan 20 with carmustine implant), the first new
treatment to be approved for recurrent brain cancer in over 20 years.
receiving approval from the FDA in 1996, its availability has enhanced the way
GBM is treated, and has offered renewed hope to patients worldwide.
Developed and marketed by Guilford Pharmaceuticals, (Nasdaq: GLFD - news)
GLIADEL® Wafer is a biodegradable polymer wafer, about the size of a dime --
that can be implanted following surgery to remove a brain tumor.
Wafer is designed to deliver the chemotherapeutic agent carmustine (BCNU)
directly to the tumor site, allowing a higher dose than can be achieved by
intravenous chemotherapy and minimizing drug exposure to the rest of the body.
"GLIADEL® Wafer is a unique treatment option that allows patients with
certain forms of primary malignant brain cancer to benefit from localized
chemotherapy without experiencing some of the side effects usually associated
with systemic chemotherapy," commented Allan J. Hamilton, MD, FACS, head of
the Department of Surgery at the University of Arizona College of Medicine.
"We are particularly excited about the positive outcome of a recent Phase III
first surgery clinical trial, which could expand the benefits of GLIADEL®
Wafer therapy to a much larger patient population."
The Potential to Offer Hope to More Patients
A Phase III clinical trial of GLIADEL® Wafer for initial surgery,
completed in June 2000, was conducted at 38 centers in 14 different countries.
A total of 240 eligible men and women between the ages of 18 and 65 were
randomly assigned to receive either GLIADEL® Wafer or placebo.
to treatment with either GLIADEL® Wafer or placebo, patients received
standard therapy for malignant glioma, which included surgery and radiation
The primary endpoint for the trial was overall survival.
Median survival in patients receiving GLIADEL® Wafer increased from
11.6 months for patients given placebo wafer to 13.9 months in patients given
GLIADEL® Wafer (p<0.03).
The p-value was determined using the logrank test,
stratified by the country in which treatment was administered.
At one year,
59 percent of patients given GLIADEL® Wafer were still alive compared to 48
percent of those given placebo (p<0.01).
Based on the results from this Phase III clinical trial, Guilford has
submitted a supplemental New Drug Application with the United States Food and
Drug Administration to seek approval to expand the labeled indication for
GLIADEL® Wafer to include first line therapy in patients newly diagnosed
with malignant glioma.
"Brain cancer is one of the most universally fatal and difficult-to-treat
of all cancers," said Thomas Grahm, MD, Tyler Neurosurgical Associates, P.A.,
"Tumors in the brain grow rapidly and often recur after removal
due to residual cancer cells embedded within the brain tissue.
Wafer offers promise because it can deliver chemotherapy directly to the tumor
site, inhibiting re-growth."
GLIADEL® Wafer is approved to treat recurrent glioblastoma multiforme.
It has generally been well tolerated.
However, GLIADEL® 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.
Patients undergoing surgery for malignant brain cancer and implantation of
GLIADEL® Wafer should be monitored closely for the following know
complications of surgery: seizures, intracranial infections, abnormal wound
healing, and brain edema.
Each of these complications has been associated
with GLIADEL® Wafer treatment.
About Brain Tumors
There are two types of brain tumors: primary and metastatic.
brain tumors originate in the brain, while metastatic brain tumors are formed
by cancer cells that originated elsewhere in the body and then spread to the
There are several types of primary brain tumors.
The most common
forms are gliomas, which originate in the glial (structural) tissue of the
brain and often cause headaches, seizures, memory loss and mood or behavior
Glioblastoma multiforme (GBM) tumors, the most common type of
glioma, are grade IV tumors, making them one of the most rapidly progressive
and universally fatal of all cancers.
The most common symptoms of brain tumors include, increasing pressure in
the skull; headaches; drowsiness; nausea/vomiting; mental changes that cause
memory and speech impairments; seizures; difficulty communicating, reasoning
or concentrating; changes in behavior, temperament or interests; sensory
problems, including vision and hearing difficulties; and paralysis, numbness
or loss of coordination.
GLIADEL® Wafer is a registered trademark of Guilford Pharmaceuticals.
Guilford Pharmaceuticals Inc. is a biopharmaceutical company engaged in
the development of biopolymer-based therapeutics for cancer and other
diseases, and novel products for the diagnosis and treatment of neurological
For more information about Brain Tumor Awareness Week, please visit
For more information about GLIADEL Wafer, visit www.gliadel.com.
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 Annual Report on Form 10-K for the year
ended December 31, 1999, that could cause the Company's actual results and
experience to differ materially from anticipated results and expectations
expressed in these forward-looking statements.
Among other things, there can
be no assurance that the results of the third multi-center Phase III clinical
trial will support approval of GLIADEL® Wafer in the U.S., Europe and
elsewhere for treatment of patients with malignant glioma at the time of first
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Guilford Pharmaceuticals, Inc.
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