By Brady Huggett
Genta Inc. made it four Phase IIIs for Genasense, launching a randomized trial in patients with chronic lymphocytic leukemia.
The new study will take place in approximately 60 centers in the United States, Canada and Europe and will involve about 200 patients that have relapsed from initial therapy for chronic lymphocytic leukemia (CCL). The trial will test whether the addition of Genasense can improve response rates, response duration and quality of life compared to standard therapy used alone. A standard second-line treatment program that combines two drugs, fludarabine and cyclophosphamide, will serve as the control and will be administered to all patients.
Genta officials were not available for comment.
Genasense, an antisense compound, targets Bcl-2, a protein overexpressed in cancer cells. It also appears to contribute to chemotherapy resistance in CCL, said Stanley Frankel, Genta's director of clinical operations in the company's press release.
Genta said the four studies - randomized trials in melanoma, myeloma and CLL, and a non-randomized study in acute myeloid leukemia - complete the list of registration-quality studies it had intended to initiate in the near term. It may start additional randomized trials in 2001, but these four trials are its key NDA-directed programs.
Earlier this month Genta began a pivotal study of Genasense in advanced multiple myeloma. (See BioWorld Today, Feb. 14, 2001.)
Genta's stock (NASDAQ:GNTA) closed unchanged Wednesday at $6.75.