Mgi Pharma (MM) (NASDAQ:MOGN)
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MGI PHARMA, INC. (NASDAQ:MOGN), a biopharmaceutical company
focused in oncology and acute care, today announced that study results
published in the February issue of the Journal of Neurosurgery show that
treatment of patients who have recurrent glioblastoma multiforme (GBM)
with both Gliadel®
Wafer and radioactive seeds (iodine-125) at the time of tumor resection,
may provide for a better outcome than treatment of patients with surgery
and either agent alone.
The study was led by Ronald E. Warnick, M.D., Chairman of the Mayfield
Clinic and professor of neurosurgery at the University of Cincinnati.
This is the first study ever conducted to evaluate the effect of these
two novel agents used simultaneously in combination with surgery to
treat recurrent GBM. The Phase 1/2 single-arm study explored the safety
and efficacy of the localized therapies in 34 patients. The dual
implantation of Gliadel Wafer and radioactive seeds was well-tolerated
among patients and may contribute to longer survival than when surgery
is coupled with either therapy alone. Additional controlled clinical
trials will need to be conducted in order to confirm this finding and
demonstrate a survival benefit in comparison to control.
“Recurrent glioblastoma is a challenging
disease, because the tumor grows and spreads so quickly,”
Dr. Warnick said. “These results suggest that
by simultaneous application of two localized therapies, Gliadel Wafer
and radioactive seeds, we may be able to provide an improved survival
benefit for this patient population. We will continue to conduct further
studies of this approach for both recurrent and newly diagnosed
glioblastoma.”
About Gliadel®
Wafer
Gliadel®
(polifeprosan 20 with carmustine implant) Wafer is indicated in patients
with newly diagnosed high-grade malignant glioma as an adjunct to
surgery and radiation. Gliadel is also indicated in patients with
recurrent glioblastoma multiforme as an adjunct to surgery. Gliadel
should not be given to individuals who have demonstrated a previous
hypersensitivity to carmustine or any of the components of Gliadel.
Patients undergoing craniotomy for malignant glioma and implantation of
Gliadel should be monitored closely for complications of craniotomy,
including seizures, intracranial infections, abnormal wound healing, and
brain edema.
Communication between the surgical resection cavity and the ventricular
system should be avoided to prevent the wafers from migrating into the
ventricular system and causing obstructive hydrocephalus. If a
communication larger than the diameter of a wafer exists, it should be
closed prior to wafer implantation. Computed tomography and magnetic
resonance imaging of the head may demonstrate enhancement in the brain
tissue surrounding the resection cavity after implantation of Gliadel.
This enhancement may represent edema and inflammation caused by Gliadel
or tumor progression. The short-term and long-term toxicity profiles of
Gliadel, when given in conjunction with chemotherapy have not been fully
explored.
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®
(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.
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
determinations by FDA regarding the safety or efficacy of Gliadel
Injection 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-K and Form 10-Q. MGI PHARMA undertakes no duty to update
any of these forward-looking statements.