Genta Cancer Drug Fails Late-Stage Trial
Friday November 26, 8:43 am ET
Genta Cancer Drug Genasense Fails Late-Stage Trial of Myeloma Patients
BERKELEY HEIGHTS, N.J. (AP) -- Cancer drug developer Genta Inc. said Friday that a late-stage clinical trial of its Genasense treatment for patients with advanced multiple myeloma did not meet its primary end-point.
In a press release, Genta said the trial evaluated whether the addition of Genasense to standard therapy with high-dose dexamethasone could delay the advance of the disease in patients who previously had received extensive therapy.
Multiple myeloma is a cancer of white blood cells called plasma cells. In myeloma, these cells, which normally produce infection-fighting antibodies, become mutated and then multiply uncontrollably. Genasense inhibits a protein that is thought to increase resistance to chemotherapy, Genta said.
The news marks the latest setback for Genta's lead drug candidate. Earlier this month, Aventis ended an agreement to jointly develop the drug with Genta, said it instead would look for a candidate that could "provide for a near-term launch." Prior to that announcment, Genta released results of a late-stage trial in patients with lymphocytic leukemia that showed the drug met primary goals but fell short of key secondary objectives. In May, a Food and Drug Administration panel voted against approving Genasense as a treatment for skin cancer.
On Friday, Dr. Raymond P. Warrell Jr., Genta's chairman and CEO, said, "The strength of the preclinical data, combined with results from two preliminary, non-randomized trials, provided a strong rationale for this Phase 3 study." He added that Genta will "analyze this trial in considerably more detail before making decisions regarding the Genasense program in myeloma."
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