By Kim Coghill

Washington Editor

Genta Inc.'s lead compound, Genasense, entered a Phase III randomized clinical trial for patients with advanced multiple myeloma.

The study will be conducted at 65 centers in the United States, Canada and Great Britain and include about 200 patients with myeloma who have relapsed from initial therapy. A standard form of treatment at this stage of the disease is the use of high-dose dexamethasone. The trial will test whether the addition of Genasense can improve response rates, response duration and quality of life compared with dexamethasone therapy used alone.

Genasense is an antisense compound that is geared toward blocking the production of Bcl-2, which is overexpressed in cancer cells and prevents the body response for programmed cell death of the tumor, said Mark Monane, vice president of equity research at Needham & Co. in New York.

Preclinical studies in Genta labs showed that Genasense is rapidly taken up by myeloma cells and that Bcl-2 protein is rapidly down-regulated with the treatment, Genta said. Lab studies also show that a combination of Bcl-2 antisense plus dexamethasone or chemotherapy is more effective in killing myeloma cells than each drug alone.

Genasense also is in Phase III clinical trials in malignant melanoma and leukemia, and in Phase II studies targeting cancers of the prostate and the lung.

Genasense has received fast-track and orphan drug designation for the melanoma indication, which is expected to reach market by the end of 2002, Monane said.

In its first year on the market for melanoma, Genasense is expected to produce about $7 million in U.S. revenues. By 2004, when the drug likely will be on the market for multiple myeloma, chronic lymphocytic leukemia (CCL) and acute myeloid leukemia (AML), sales should reach $131 million, Monane said.

Through the sale of 4.28 million shares of stock, Genta, of Berkeley Heights, N.J., in November raised $28.9 million. Following the funding, the company had about $53 million in cash and said the funds should last about two years. (See BioWorld Today, Nov. 14, 2000.)

Genta officials could not be reached for comment Tuesday.

Genta's stock (NASDAQ:GNTA) closed Tuesday at $8, up 31.25 cents. n