MGI PHARMA Initiates Patient Dosing in Phase 3 Clinical Trial of Irofulven In Pancreatic Cancer
Pivotal Trial Enrollment Begins for Advanced Pancreatic Cancer Patients Not Responding to Current Standard of Care
MINNEAPOLIS, Feb. 7 /PRNewswire/ -- MGI PHARMA, INC., (Nasdaq: MOGN - news) today
announced the initiation of patient dosing in its pivotal Phase 3 trial of irofulven, its novel anti-cancer
compound, for patients with advanced-stage pancreatic cancer. Based on recent discussions with the
U.S. Food and Drug Administration (FDA), MGI PHARMA finalized its study protocol. The trial is a
randomized, multi-center, international trial in advanced-stage pancreatic cancer patients whose disease
progressed after treatment with gemcitabine (Gemzar®), the current standard-of-care treatment. In this
Phase 3 trial, irofulven is being compared to 5-fluorouracil (5-FU), a commonly prescribed salvage
chemotherapy for pancreatic cancer. Survival is the primary endpoint, with objective tumor response and
other clinical benefit measures as secondary endpoints.
An intermittent, every other week dosing schedule for irofulven is being used, based upon the greatly
improved tolerance and better dose intensity that was seen with this schedule in a dose optimization trial.
5-FU will be given as a continuous intravenous infusion. A 2:1 randomization will be used where two
patients will be treated with irofulven for each patient receiving 5-FU.
Dr. Daniel Von Hoff, professor of medicine and director at the Arizona Cancer Center and a renowned
oncology researcher and drug developer, is the lead investigator for MGI PHARMA's pivotal trial.
``Irofulven has caused regressions of some patients' pancreatic cancer in Phase 1 and 2 trials,'' notes Dr.
Von Hoff. ``This pivotal clinical trial, with the new dose regimen, will define the role irofulven will have in
the treatment of patients with advanced pancreatic cancer.''
``Initiating this pivotal Phase 3 trial with irofulven is an important milestone for MGI PHARMA,'' said Dr.
Michael Cullen, vice president, clinical affairs and chief medical officer at MGI PHARMA. ``Our target
is to enroll the approximately 300 patients needed in this trial within 18 months, which would allow us to
file an NDA (New Drug Application) with the FDA sometime in 2003.''
Dr. Tomislav Dragovich, assistant professor of medicine, section of Hematology/Oncology at the Arizona
Cancer Center and a principal investigator in MGI PHARMA's Phase 3 trial, commented,
``Unfortunately, there has been little hope for patients with pancreatic cancer who failed first line therapy
with gemcitabine. So far, no treatment approach has clearly demonstrated the ability to prolong survival.
Therefore, we are very excited about this opportunity to investigate a promising new drug, irofulven, in
this subset of patients with refractory pancreatic cancer.''
About Irofulven
Irofulven (also known as MGI 114, hydroxymethylacylfulvene, or HMAF) is the first product candidate
being developed by MGI PHARMA from its family of proprietary anti-cancer compounds called
acylfulvenes. Irofulven is currently being tested in a series of clinical trials for the treatment of solid
tumors, across a variety of cancers. Irofulven has demonstrated promising anti-tumor activity as a single
agent in clinical testing against pancreatic, ovarian and prostate cancers. Side effects from irofulven are
comparable to those seen with marketed chemotherapies and include bone marrow suppression
(decreases in platelets or white blood cell counts), nausea, vomiting and fatigue. Patients and healthcare
providers seeking information on the various irofulven clinical trials may call MGI PHARMA's Medical
Communications Help Line at 800-562-5580 or the National Cancer Institute at 800-4-CANCER.
MGI PHARMA, INC., is an oncology-focused pharmaceutical company that acquires, develops and
commercializes differentiated products that meet patient needs. MGI PHARMA focuses its sales efforts
solely in the United States and collaborates with other pharmaceutical or biotechnology companies for its
products in international markets. For more information about MGI PHARMA, please visit the
Company's web site at mgipharma.com .
This news release contains forward-looking statements that may include statements regarding intent,
belief or current expectations of the company and its management. These forward-looking statements are
not guarantees of future performance and involve a number of risks and uncertainties that may cause the
company's actual results to differ materially from the results discussed in these statements. Factors that
might affect MGI PHARMA's results include, but are not limited to the ability of MGI PHARMA's
product candidate irofulven to be proven safe and effective in humans 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,
and other risks and uncertainties detailed from time to time in the company's filings with the Securities and
Exchange Commission. MGI PHARMA does not intend to update any of the forward-looking
statements after the date of this news release to conform them to actual results.
SOURCE: MGI PHARMA, INC.
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