Just posted the summary but after reading it a few times I thought the full article deserved to be posted and it owns "posting subject" ...
BioAlliance Pharma suspends the Phase II/III trial of doxorubicin Transdrug in primary liver cancer, following advice from the Drug Safety Monitoring Board and the Steering Committee
Paris, July 16th, 2008 - BioAlliance Pharma SA (Euronext Paris -BIO), the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV, announced today the suspension of its Phase II trial of doxorubicin Transdrug in primary liver cancer. The company is following advice (as set out in the study schedule) provided by the Drug Safety Monitoring Board and the Steering Committee, which have been continuously monitoring the trial's progress. On the basis of the initial data, the two committees observed a clinical benefit but also more frequent and more severe pulmonary adverse events than expected and have thus recommended suspension of the trial, given the incidence of this type of effect.
This type of acute pulmonary damage was observed in Phase I/II trial at a dose of 35mg/m2 (the maximum tolerated dose) but had not been observed at 30mg/m2, the dose chosen for repeated administrations in the next development phase.
In this Phase II trial, doxorubicin Transdrug was being compared with the current standard of care (a control group undergoing Trans-Arterial Chemo-Embolization).
In terms of the criteria for assessing the efficacy and safety of repeated intra-arterial hepatic injection of doxorubicin Transdrug, the efficacy endpoint was based on progression-free survival after 3 months of treatment.
"Non-operable primary liver cancer in cirrhotic patients has a very poor prognosis. There are few effective treatments, and it is therefore important to evaluate the benefit/risk ratio of therapeutic innovations," stated Dominique Costantini, BioAlliance Pharma's co-founder, President and CEO. "We scheduled Drug Safety Monitoring Board and Steering Committee meetings into the trial's timeline and we have been following their recommendations".
Our product portfolio is based on independent innovations, and each has its own risks. This allows us to redirect our focus so if this trial has to be suspended permanently, we shall bring another compound into the clinical phase," added Dominique Costantini.
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