By Randall Osborne
West Coast Editor
The shelf is empty, but MGI Pharma Inc.¿s cupboard is hardly bare ¿ the company having entered into an agreement to sell the final 1 million shares of its shelf registration for $11.8 million in order to advance a pair of Phase III anticancer drugs.
Minneapolis-based MGI sold the first 4 million of the registration to U.S. Bancorp Piper Jaffray Inc., also of Minneapolis, in May to raise $29.2 million, and now Piper Jaffray has signed up to buy the rest. In the meantime, MGI has raised $31 million through a private placement of more than 3 million shares, putting the company in a good position. (See BioWorld Today, May 10, 2001, and Nov. 2, 2001.)
The company has raised about $77 million this year, said Maggie Knack, director of investor relations and corporate communications.
One of the drugs is palonosetron, a 5HT-3 antagonist licensed from Lugano, Switzerland-based Helsin Healthcare SA, that affects serotonin and suppresses nausea and vomiting in chemotherapy patients. The drug lasts longer in plasma than 5-HT3 antagonists already on the market, MGI said.
¿There are four trials in that program, and we¿ve completed patient enrollment in the first trial,¿ Knack told BioWorld Today. ¿The whole program will conclude around year-end.¿
Data from earlier studies likely will be presented at a scientific meeting in the spring, but availability of Phase III numbers is uncertain, Knack said.
¿For this kind of trial, it¿s yet to be determined, but it¿s a shorter period of time than other trials,¿ she said. ¿At this point, we¿re indicating a [new drug application] will be submitted around mid-2002.¿
Irofulven, the second drug, is MGI¿s first in a series of anticancer compounds called acylfulvenes, which works like alkylating agents but acts against tumors in which alkylators often do not. It binds to tumor cells¿ DNA and protein targets within the cell to block replication.
¿We plan to conclude enrollment in pancreatic cancer in the third quarter of 2002,¿ Knack said, adding that the expected enrollment date for the ovarian cancer trial has not been disclosed. Phase II studies are experimenting with the drug in ovarian and prostate cancers, as well as in combination trials with Camptosar, Gemzar and Taxotere.
The company also has a second-generation antisense compound, called MG98, in Phase II studies for head and neck cancer, Knack said.
MGI¿s stock (NASDAQ:MOGN) closed Tuesday at $13.93, down 36 cents.