Shares of biopharmaceutical company
rose sharply Monday after trial data showed that its anticancer injection reduced the risk of cancer relapse in leukemia patients on chemotherapy.
Shares were up 48 cents, or 37.5%, to $1.76. Monday's report represents follow-up data collected in an ongoing phase III study that previously met its primary endpoint of showing that the drug could enhance the disease-fighting response of some cancer patients.
Trial data for the drug, known as Genasense, showed a longer-term remission and lower risk of relapse in patients with bone marrow producing too many white blood cells, a condition known as chronic lymphocytic leukemia, which causes anemia and increased susceptibility to infections.
However, Genta says that severe and even life-threatening side effects occurred in a greater percentage of patients after 30 days than in those receiving chemotherapy alone.
Side effects included complications with intravenous catheters and a reduction in platelet count that could keep blood from clotting. Patients experiencing these side effects discontinued treatment.
The key finding of Monday's data was that among patients who showed a response to their disease in the trial, fewer who took Genasense relapsed.
"These new data provide important supportive evidence of the substantial clinical benefit for patients who receive Genasense in addition to standard chemotherapy for their disease," said Genta's President and Chief Medical Officer Dr. Loretta Itri in a press release.
Genta plans to discuss another study design with FDA and seek accelerated approval for the drug in chronic lymphocytic leukemia.
Genasense has received orphan drug status from the FDA. In order to receive that status, a drug must treat rare diseases but have little impact on a company's sales. If Genasense is approved, Genta would have seven years of marketing exclusivity.
The company expects to complete its new drug application later this year.