With an FDA decision expected by the end of next month on the antisense drug Genasense in chronic lymphocytic leukemia, Genta Inc. is bringing in about $16 million through the sale of 20 million shares of common stock.

The Berkeley Heights, N.J.-based firm entered agreements with institutional investors in a registered direct offering, priced at 79 cents per share. Rodman & Renshaw LLC, of New York, served as placement agent.

Proceeds are expected to fund regulatory applications for Genasense, support clinical development of additional compounds and for general corporate purposes. The company could not provide further comment due to quiet-period restrictions.

News of the stock sale, expected to close on or about Sept. 22, caused Genta's stock (NASDAQ:GNTA) to lose 31.8 percent Wednesday, again falling below $1 despite closing at $1.10 the day before on positive Genasense data in melanoma. Shares closed Wednesday at 75 cents, down 35 cents.

Genta filed a new drug application in December to use Genasense (oblimersen sodium) injection with fludarabine and cyclophosphamide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The FDA is expected to review the NDA by Oct. 29; however, the agency's Oncology Drugs Advisory Committee (ODAC) already had its say on the application, and the news wasn't good.

Members of ODAC voted 7-3 earlier this month to recommend denial of the NDA, based on the concerns of FDA reviewers that the drug's benefit was not substantial enough, even though it met the primary endpoint in one pivotal trial. While the FDA is not bound by that recommendation, the agency's decisions usually mirror those of the committee. (See BioWorld Today, Sept. 7, 2006.)

Described as a chemotherapy sensitizer, Genasense is designed to work by blocking the production of the Bcl-2 protein, which is related to the resistance of cancer cells to existing treatments.

Though it's yielded promising results in early clinical studies, the drug faltered in the late-stage trials. Preliminary results from a 241-patient Phase III CLL study, reported in 2004, were mixed. The drug hit its primary endpoint - an increase in the proportion of patients who achieved a complete or nodular partial response - but missed the secondary endpoints of time to disease progression and overall survival. Further analysis, however, indicated that the addition of Genasense extended the duration of complete remission or nodular partial remission longer than for patients on chemotherapy only. (See BioWorld Today, Nov. 10, 2004.)

Genta is working on a special protocol assessment with the FDA for a planned confirmatory Phase III study of Genasense in CLL.

The company also is forging ahead with Genasense in other indications, even advanced melanoma, for which Genasense received another negative opinion from ODAC in 2004, based on the drug missing the primary endpoint in the pivotal Phase III study. Since then, Genta has continued to analyze data and, earlier this week, reported data at the Melanoma X and the Third International Melanoma Research Congress in the Netherlands, showing a link between patient survival and a biomarker called LDH.

Patients with a normal baseline LDH showed significantly superior efficacy outcomes with Genasense. That subgroup comprised about two-thirds of the patients in the trial.

A marketing authorization application for Genasense in advanced melanoma is under review by European regulators.

Genasense is in a Phase III trial as an addition to standard therapy in patients with acute myeloid leukemia, and also is being tested in hormone-refractory prostate cancer and non-small-cell lung cancer.

Genta posted a net loss of $14.6 million, or 11 cents per share, for the second quarter. As of June 30, the company had cash, cash equivalents and short-term investments of $35.8 million.