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Gliadel(R) Wafer Clinical Data Presented at Society for Neuro-Oncology Meeting


Posted on: 11/20/2006

Gliadel(R) Wafer Clinical Data Presented at Society for Neuro-Oncology Meeting 

 

   
    ORLANDO, Fla., Nov. 20 /PRNewswire-FirstCall/ -- MGI PHARMA, INC.
(Nasdaq: MOGN), a biopharmaceutical company focused in oncology and acute
care, today summarized interim results from a phase 2 combination study of
Gliadel(R) Wafer (polifeprosan 20 with carmustine implant) in patients with
newly-diagnosed, resectable, high grade malignant gliomas presented at the
2006 Society for Neuro-Oncology (SNO) Annual Meeting. Interim data from 35
patients with this aggressive brain tumor showed a median survival of 18.6
months when Gliadel Wafer and temozolomide are used in combination with
surgery and radiotherapy.
    "Although preliminary, these data are intriguing and warrant additional
clinical investigation," commented Renato LaRocca, M.D., Principal
Investigator of the study and Director of the Kentuckiana Cancer Institute.
"By using quadruple-modality therapy, we may be having an impact on select
patients with this devastating tumor. With each new study in brain tumors,
we gain further insight into the appropriate sequencing of novel treatment
combinations."
    About the Study
    This phase 2, multi-center trial began in July 2003 and is planned to
enroll a total of 40 patients. Eligible patients were 18-72 years of age
with surgically operable, initial high-grade malignant glioma. Patients
underwent craniotomy and Gliadel Wafer implantation (7.7 mg carmustine per
wafer), followed by limited field radiotherapy (2 Gy/day x 30 fractions)
with concomitant temozolomide (75 mg/m(2)/day), and then up to 18
sequential cycles of monthly temozolomide (200 mg/m(2)/day for 5 days) as
tolerated unless there was evidence of disease progression. Pneumocystis
carinii prophylaxis was not required during concomitant treatment with
radiotherapy and temozolomide.
    As of September 29, 2006, 35 patients have been enrolled at three
centers. Glioblastoma multiforme was diagnosed in 34 patients and
anaplastic astrocytoma in one patient. The median patient age is 57 years,
and the median Karnofsky Performance Status is 100 (range 70-100). At
interim analysis, median follow-up was 10.4 months (range 0.6-29.7).
Recurrence has been documented in 25 patients and 19 patients have died.
Three patients were withdrawn from the study, one patient withdrew and
transferred care following recurrence, and one patient died prior to
initiation of radiotherapy and concomitant temozolomide. Median survival is
18.6 months and the 1-year survival rate is 64%. Median progression free
survival is 6.4 months and the one year progression free survival is 30%.
    The most frequently reported adverse event included constipation (14
patients), nausea (14 patients) and fatigue (11 patients). Trial sites
include Kentuckiana Cancer Institute, the University of Missouri School of
Medicine and Baylor College of Medicine.
    About Gliadel(R) Wafer
    Gliadel Wafer (polifeprosan 20 with carmustine implant) is a
biodegradable wafer containing the chemotherapy agent carmustine, or BCNU,
and is indicated in newly diagnosed patients with high-grade malignant
glioma as an adjunct to surgery and radiation. Gliadel Wafer is also
indicated in recurrent glioblastoma multiforme patients as an adjunct to
surgery. Gliadel Wafer is the only FDA approved brain cancer treatment
capable of providing localized delivery of chemotherapy directly to the
site of the tumor. Up to eight Gliadel wafers can be implanted in the
resection cavity after a tumor is surgically removed. As a Gliadel Wafer
dissolves, BCNU is delivered locally, providing chemotherapy to the
surgical resection cavity.
    Side effects have been reported in patients receiving Gliadel Wafer.
Although these events may result as a consequence of brain surgery
(craniotomy) without Gliadel Wafer, they may occur more frequently when
Gliadel Wafer is used. The following categories of adverse events are
possibly related to treatment with Gliadel during initial resection
including seizure, brain edema, healing abnormalities, and intracranial
infection. The following four categories of adverse events are possibly
related to treatment with Gliadel for recurrent disease: post-operative
seizure, healing abnormalities, intracranial hypertension and intracranial
infection.
    About MGI PHARMA
    MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and
acute care that acquires, researches, develops and commercializes
proprietary products that address the unmet needs of patients. MGI PHARMA
markets Aloxi(R) (palonosetron hydrochloride) Injection, Dacogen(TM)
(decitabine) for Injection, and Gliadel(R) Wafer (polifeprosan 20 with
carmustine implant) in the United States. The Company directly markets its
products in the U.S. and collaborates with partners to reach international
markets. For more information about MGI PHARMA, please visit
http://www.mgipharma.com.
    International distribution partners for Gliadel Wafer include: Link
Pharmaceuticals Ltd. in the United Kingdom and the Republic of Ireland,
Link Pharmaceuticals EU Ltd. in France and Germany, Dompe Farmaceutici
s.p.a. in Italy, Laboratorios del Dr. Esteve S.A. in Spain and Portugal,
Genesis Pharma S.A. in Greece, BioPro Pharmaceuticals Ltd. in South East
Asia, PharmaPlan Pty Ltd. in South Africa and Medison Pharma Ltd. in
Israel.
    This news release contains certain "forward-looking" statements within
the meaning of the Private Securities Litigation Reform Act of 1995. These
statements are typically preceded by words such as "believes," "expects,"
"anticipates," "intends," "will," "may," "should," or similar expressions.
These forward-looking statements are not guarantees of MGI PHARMA's future
performance and involve a number of risks and uncertainties that may cause
actual results to differ materially from the results discussed in these
statements. Factors that might cause MGI PHARMA's results to differ
materially from those expressed or implied by such forward-looking
statements include, but are not limited to, the ability of MGI PHARMA's
product candidates to be proven safe and effective in humans, to receive
marketing authorization from regulatory authorities, and to ultimately
compete successfully with other therapies; continued sales of MGI PHARMA's
marketed products; development or acquisition of additional products;
reliance on contract manufacturing; changes in strategic alliances;
continued access to capital; ability of MGI PHARMA to successfully complete
the integration of Guilford with its existing operations; the risk that the
perceived advantages of the Guilford transaction may not be achieved; and
other risks and uncertainties detailed from time to time in MGI PHARMA's
filings with the Securities and Exchange Commission including its most
recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to update
any of these forward-looking statements to conform them to actual results.
    Contacts:
    MGI PHARMA, INC.
    Jennifer Davis
    212-332-4381
    IR@mgipharma.com

    For more information about Gliadel Wafer, contact:
    Elinor Kline
    Edelman
    212-704-4528
    Elinor.Kline@Edelman.com


SOURCE MGI PHARMA, INC.

 


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