another sad day
04/17 7:23A (DJ) PRESS RELEASE: MGI Stops Phase 3 Pancreatic Cancer Trial
MGI PHARMA Stops Phase 3 Irofulven
Clinical Trial for Refractory Pancreatic Cancer Patients; Irofulven
Development Program Continues For Other Tumor Targets
MINNEAPOLIS--(BUSINESS WIRE)--April 17, 2002--MGI PHARMA, INC.,
(Nasdaq:MOGN) today announced that it has stopped its Phase 3 clinical trial
of its anti-cancer drug candidate, irofulven, for gemcitabine-refractory
pancreatic cancer patients.
Despite evidence of irofulven activity, preliminary analysis of the Phase 3
data by an independent Data and Safety Monitoring Board (DSMB) indicated that
the comparator agent 5-fluorouracil (5-FU) demonstrated a greater than
expected survival benefit, making it statistically improbable that the final
study results could achieve MGI's planned objectives for the trial. For this
reason, MGI will no longer pursue this specific indication for irofulven in
gemcitabine-refractory pancreatic cancer. Irofulven will continue to be
available to currently-enrolled pancreatic cancer patients in this trial who
are experiencing clinical benefit.
"Certainly, we are disappointed with this recent development. Although
irofulven appears to have provided benefit to some pancreatic cancer patients
in this trial, it was surprising that 5-FU performed substantially above the
trial design assumptions," said Chuck Blitzer, MGI's president and CEO. "This
Phase 3 trial of irofulven for the treatment of pancreatic cancer was but one
trial in MGI's larger program to treat a variety of solid tumors and we will
now focus our energies on other ongoing and planned clinical trials of
irofulven."
The Company plans to continue its broad irofulven development program,
including the evaluation of irofulven as monotherapy as well as in combination
therapy for tumor types affecting large numbers of patients. Previous and
ongoing Phase 2 clinical trials have demonstrated activity of irofulven in
other tumors, such as ovarian, prostate, and hepatocellular cancer. In
preclinical models, irofulven has demonstrated profound anti-tumor activity
when combined with other agents, leading to a series of Phase 1 clinical
trials of irofulven in combination with approved agents such as irinotecan,
gemcitabine, docetaxel, and cisplatin. Combination therapies represent MGI's
best opportunity to develop irofulven for use in prevalent tumor types, such
as breast, lung, and colon cancers.
"Refractory pancreatic cancer remains one of the most difficult cancers to
treat and it is unfortunate that there currently remains no truly effective
therapy for this patient population," said Michael Cullen, M.D., the Company's
chief medical officer.
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 anti-tumor activity as
a single agent in clinical testing against pancreatic, ovarian, prostate and
hepatocellular cancers. Irofulven is also being studied for use in combination
with Camptosar(R) (CPT-11 or irinotecan), Gemzar(R) (gemcitabine
hydrochloride), Taxotere(R) (docetaxel), and cisplatin. Side effects from
irofulven are similar to marketed chemotherapies and include bone marrow
suppression (decreases in platelets or white blood cell counts), nausea,
vomiting, fatigue, and visual disturbances.
Patients and health care providers seeking more information on the various
irofulven clinical trials may call MGI PHARMA toll-free at 800/562-5580 and
press 1 to reach our Medical Communications Help Line or the National Cancer
Institute's Cancer Information Service at
800/4-CANCER (TTY 800/332-8615).
Updated Conference Call & Webcast Information
MGI PHARMA's management team will discuss this irofulven Phase 3 trial
announcement as well as the preliminary analysis of the pivotal Phase 3 trials
of palonosetron announced separately today, along with the Company's 2002
first quarter financial results, during a conference call at 9:00 a.m. Eastern
Time today, Wednesday, April 17, that will be broadcast live over the
Internet. Interested parties may access the webcast via MGI's Web site at
www.mgipharma.com. This conference call was re-scheduled from Wednesday
afternoon to this earlier 9:00 a.m. morning time.
About MGI PHARMA
MGI PHARMA, Inc., is an oncology-focused pharmaceutical company that
acquires, develops and commercializes proprietary products that address the
unmet needs of cancer patients. MGI is building a balanced portfolio of
proprietary pharmaceuticals, and intends to become a leader in oncology. The
company 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, please visit the
Company's web site at 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 the Company'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, such as irofulven, 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; and other risks and uncertainties detailed from time to time in the
Company's filings with the Securities and Exchange Commission including in
Exhibit 99 to 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. |
