Boehringer Ingelheim to launch phase 3 leukaemia trials in early 2013

Hannah Blake

pharmaphorum

Based on positive phase 2 results of Boehringer Ingelheim’s compound volasertib, for the treatment of leukaemia, the drugmaker has announced plans to initiative phase 3 clinical trials in early 2013.

In phase 2, the investigational haematology / oncology compound, volasertib, was tested in newly diagnosed patients with acute myeloid leukemia (AML) considered ineligible for intensive remission induction therapy. The results demonstrated higher rates of objective response (primary endpoint) and an improvement in event free survival (secondary endpoint) in patients treated with volasertib in combination with low-dose cytarabine (LDAC) compared to patients treated with LDAC alone.

“The results from this trial provide insight into the potential of volasertib* combined with LDAC in patients with AML not eligible for intensive induction chemotherapy. Based on the results observed in this difficult-to-treat patient population, we are expanding our volasertib* haematology clinical programme to further explore this investigational compound.”

Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.

Acute leukaemias are rare diseases, with AML being the most common type of leukemia in adults.

The planned phase 3 clinical trials, POLO-AML-2, will enroll eligible patients aged 65 or older with previously untreated AML who are ineligible for intensive remission induction therapy.

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Related news:

Preliminary results from Boehringer Ingelheim’s volasertib Phase II study on AML (News-Medical Net)

Boehringer Ingelheim to initiate Phase III study in leukaemia with its compound volasertib* based on positive Phase II results (Financial Post)

Reference links:

Boehringer Ingelheim press release

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