Genta Inc. said Monday it plans to increase enrollment in its Phase III melanoma study of Genasense, a move expected to delay its new drug application filing from late 2002 to mid-2003.
Genta Chairman and CEO Raymond Warrell said in a conference call that Genta and its partner in the program, Aventis SA, of Frankfurt, Germany, were taking a conservative approach by increasing the number of patients from 450 to 750 in light of recent "high-profile drug failures" that reflect "more aggressive regulatory strategy."
"Our Aventis colleagues have strongly felt that this minor delay was more than outweighed by overall risk reduction and by the desire to submit simultaneous global flings, and we concur," Warrell said.
Genta, of Berkeley Heights, N.J., and Aventis entered the collaboration in April in a deal valued potentially at $480 million to develop Genta's Genasense, a targeted inhibitor of Bcl-2, a protein overexpressed in many solid and hematologic tumors. It is in multiple Phase III trials for melanoma, multiple myeloma, chronic lymphocytic leukemia and non-small-cell lung cancer, as well as Phase II studies for leukemia, lymphoma and prostate and small-cell-lung cancer. (See BioWorld Today, April 30, 2002.)
The enrollment goal should be met in the second half of the year, Warrell said.
Warrell also said in the call that Genta's chief financial officer, Al Fernandez, had left the company for personal reasons, and an executive search firm had been retained to find a replacement.
In addition, Genta said that it received $72 million in gross proceeds from Aventis pursuant to a purchase of common stock, based on the recently concluded collaboration for Genasense. The equity purchase followed Genta's achievement of a clinical research milestone. Aventis purchased 6,665,498 shares at $10.79 per share, representing 9.99 percent of outstanding voting shares.
The potential $480 million deal included $135 million in initial and near-term payments, a total that included the $72 million; $40 million in development fees; $10 million as a licensing fee; and $10 million in convertible debt.
The purchase is subject to a minimum two-year holding period, certain other transfer restrictions and a standstill agreement.
Genta's stock (NASDAQ:GNTA) fell $2.06 Monday, or 22.3 percent, to close at $7.19.