Alfacell Corp. said Wednesday its lead drug candidate failed to improve the survival rate of patients with a special type of cancer, though the biotechnology company plans on asking for approval based on positive results from a secondary goal.
The company said the drug, Onconase, did not improve survival in patients with unresectable malignant mesothelioma, a type of cancer that affects cells lining of the chest, abdomen and heart cavity. Unresectable refers to the fact that the cancer can't be surgically removed.
The drug candidate, however, did improve the survival rate in patients who had failed one prior round of chemotherapy treatment. Alfacell said it will ask the Food and Drug Administration to approve Onconase for that indication.
The late-stage study results, which are still preliminary, are based on 320 patients. In the study's secondary goal, patients taking the combination of Onconase and the chemotherapy drug doxorubicin had a median survival rate of 10.5 months, compared with 8.7 months for patients only taking doxorubicin.
Alfacell expects to complete its submission with the FDA by the end of 2008.
U.S. commercial rights for Onconase have been licensed to Par Pharmaceutical Inc.
Shares of Alfacell fell 65 cents, or 38 percent, to $1.05 in after-hours trading after rising 5 cents, or 3 percent, to $1.70 during the regular trading session.
Shares of Woodcliff Lake, N.J.-based Par rose as much as 17 cents to $18.44 in after-hours trading after falling 43 cents, or 2.3 percent, to close at $18.27 during the regular trading session.
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