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S-A cancer drug fails in phase III trial

Sanofi-aventis' investigational oncology drug iniparib has failed to meet the efficacy goals of a phase III clinical trial in patients with a hard-to-treat form of breast cancer

Sanofi-aventis' (S-A) investigational oncology drug iniparib has failed to meet the efficacy goals of a phase III clinical trial in patients with metastatic triple-negative breast cancer, a particularly hard-to-treat form of the disease in which there is not over-expression of estrogen, progesterone or HER2 and so patients are not good candidates for hormone-based and targeted therapies.

Iniparib did not meet the primary endpoints of overall survival and progression-free survival in the 519-subject US study, which compared a standard chemotherapy regimen (gemcitabine and carboplatin) with the same regimen plus the investigational therapy.

However, the iniparib regimen did demonstrate an improvement in overall survival and progression-free survival in patients in the second- and third-line setting.

"We are conducting in-depth analysis to gain further insight into these phase III results,” said Debasish Roychowdhury, head of S-A Oncology.  The company plans to discuss the data from the study with health regulators in the US and EU in the near future, as well as to present the results at an upcoming medical meeting.

Iniparib is intended to work by inhibiting PARP1, or poly (ADP-ribose) polymerase-1, in order to prevent malignant cells from repairing damaged DNA, thereby halting tumor growth.

S-A acquired iniparib (also known as BSI-201) when it bought the privately held, California-based cancer drug development company BiPar Sciences in 2009. The drug, which is BiPar's lead product candidate, is also in phase III trials for patients with squamous non-small cell lung cancer and phase II trials for patients with lung and other cancers.

28th January 2011

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