MGI Pharma Inc. lost more than half its market value onMonday, closing down $11.63 at $10.75, following theannouncement that the company has suspended clinical trialsof MGI 136, a chemoprotective agent.
The Minneapolis company (NASDAQ:MOGN) said it wasimmediately halting Phase III trials of MGI 136 becausepatients receiving the therapy were dropping out at a higherrate than those receiving a placebo, and were losing moreweight, according to spokeswoman Lori Weiman.
The trial was testing the drug's ability to reduce the toxiceffects of cisplatin, a chemotherapeutic, and to stimulate bonemarrow.
An independent safety monitoring committee, made up ofuniversity oncologists and statisticians, met on Saturday andrecommended halting the trials. According to Weiman, uponfurther review of the clinical data, the committee couldrecommend resumption of the trials. It is expected to make adecision within two to four weeks, she said.
MGI's action came just more than a week after a Food and DrugAdministration advisory committee recommended against amarketing application from U.S. Bioscience Inc. for anotherchemoprotective agent, Ethyol. The Oncology Drugs AdvisoryCommittee recommended that additional studies be conductedto demonstrate Ethyol's efficacy.
In response to the Ethyol rejection, MGI's chairman and CEO, Dr.Kenneth F. Tempero, issued a statement last Monday that said:"While MGI 136 is still in clinical testing and therefore subjectto all the risks associated with development-stage products, weare confident that the design of our clinical studies isscientifically sound and will, therefore, continue itsdevelopment until the targeted completion in 1993 or untilthere is a compelling reason -- good or bad -- to stop thetrials."
"I think MGI 136 is dead," said Patricia Padgett Lea, analyst atVector Securities International. "It seems to decrease toleranceto chemotherapy," precluding efficacy.
Lea said she still recommends MGI at current prices as a "long-term buy" because of the potential revenues from Salagen, adrug that treats radiation-induced dry mouth. MGI estimates apotential $100 million U.S. market for Salagen. The company onMonday said it plans to file a new drug application for the drug"imminently."
Lea said the market has overreacted to the rejection of U.S.Bioscience's Ethyol. "I have no doubt the drug is approvable,"Lea told BioWorld. She has a year-end target of $44 for U.S.Bioscience (AMEX:UBS). The stock fell $13.75 to $17.75immediately after the FDA meeting. It fell another $1.25 onMonday to close at $15.75.
Dr. Steven Piantadosi, a member of the FDA panel from JohnsHopkins Oncology Center, told BioWorld that "there are a lot ofgenerally favorable feelings for Ethyol on the committee. Thecommittee recommended that the clinical trial that wassuspended be completed. ... I think Ethyol is still alive and inthe pipeline."
Chemoprotectives might not receive widespread use even ifthey are approved, according to Dr. Paul Engstrom, anoncologist at the Fox Chase Cancer Center in Philadelphia and amember of the American Society of Clinical OncologyCommittee on Cancer Prevention and Control.
"The chemotherapy community may not see a need for themright now," Engstrom told BioWorld. "The way that toxicity isbeing controlled in bone marrow is to boost bone marrow withcytokines that stimulate bone marrow production ofgranulocytes." Many oncologists believe that bone marrowstimulation with colony stimulating factors is more effectivethan chemoprotection, according to Engstrom.
-- Steve Usdin BioWorld Washington Bureau
(c) 1997 American Health Consultants. All rights reserved.