Healthcare Industry News: Esteve
News Release - November 20, 2006
Gliadel(R) Wafer Clinical Data Presented at Society for Neuro-Oncology MeetingORLANDO, Fla., Nov. 20 (HSMN NewsFeed) -- 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® 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 Three patients were withdrawn from the study, one patient withdrew and transferred care following recurrence, and one patient died prior to initiation of radiotherapy and concomitant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® 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® (palonosetron hydrochloride) Injection, Dacogen(TM) (decitabine) for Injection, and Gliadel® 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 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.
Source: MGI PHARMA
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