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Reuters Health Information (2004-09-20): Investigational drug fails to improve survival in melanoma metastasized to liver Drug & Device Development
Investigational drug fails to improve survival in melanoma metastasized to liver
Last Updated: 2004-09-20 13:57:11 -0400 (Reuters Health)
PHILADELPHIA (Reuters) - Maxim Pharmaceuticals Inc.
said a phase III trial to confirm the benefit of its drug Ceplene
(histamine dihydrochloride) for patients with secondary liver cancer,
failed to show an improvement in overall survival rates, the trial's
primary endpoint.
The trial, undertaken to confirm the results of an earlier study,
focused on patients with malignant melanoma that had metastasized to
the liver. The confirmation study evaluated Ceplene in combination with
interleukin-2 (IL-2). It has been approved in the U.S. for the
treatment of advanced skin tumours.
In April, Maxim said it had received approval from the U.S. Food and
Drug Administration to provide Ceplene to melanoma patients while
investigation of the drug continued in the confirmation trial.
In May, the company reported positive results from a phase III trial
investigating Ceplene plus IL-2 in the treatment of acute leukaemia
(AML) in patients in complete remission. Maxim said it plans to seek
regulatory approval in the U.S. and Europe to use Ceplene to treat AML
patients.
The American-Swedish drugmaker will continue to evaluate the data
from the current study and believes that Ceplene still holds promise
for the treatment of certain cancers, it said in a statement.
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