Guilford Pharmaceuticals Announces Promising Results at ASCO in Study of Newly Diagnosed High Grade Malignant Glioma
18 5월 2005 - 4:39AM
PR Newswire (US)
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, +1-202-944-5193, , for Guilford
Pharmaceuticals Web site: http://www.guilfordpharm.com/
http://www.gliadel.com/ Company News On-Call:
http://www.prnewswire.com/comp/112882.html
Copyright
Guilford (NASDAQ:GLFD)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
Guilford (NASDAQ:GLFD)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024
Guilford Pharmaceuticals (MM) (나스닥)의 실시간 뉴스: 최근 기사 0
More Guilford Pharmaceuticals (MM) News Articles