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Boehringer Ingelheim Presents New Phase II Data for Volasertib in Adult Patients with AML
Date:12/10/2012

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Boehringer Ingelheim intends to begin recruitment of a Phase III study (NCT01721876) to assess the efficacy and safety of volasertib in combination with LDAC compared with LDAC alone in early 2013.  The planned Phase III trial, POLO-AML-2, will enroll eligible patients aged 65 or older with previously untreated AML who are ineligible for intensive remission induction therapy.6  For additional information on the trial, please visit ClinicalTrials.gov.

About Volasertib
Volasertib, an investigational inhibitor of polo-like kinase (Plk), is one of several late-stage compounds that Boehringer Ingelheim is currently evaluating in clinical trials for various solid tumors and hematological cancers.

Of the company's ongoing research in cell cycle inhibition, the volasertib clinical development program is the furthest advanced. Boehringer Ingelheim is one of the first companies to advance Plk inhibitors into clinical development.

Volasertib is designed to inhibit the activity of Plk1, an enzyme that regulates cell division (mitosis).  This inhibition is intended to result in prolonged cell cycle arrest and ultimately cell death (apoptosis).7

Volasertib is not approved by the FDA; its safety and efficacy have not been established.

About Acute Myeloid Leukemia (AML)
AML is a cancer of the bone marrow and the blood.8  It is one of the most common types of leukemia in adults, accounting for 25 percent of all adult leukemias in the Western world,9 and has one of the lowest survival rates of all leukemias.2

AML is primarily a disease of later adulthood; the average age of an AML patient is 65 years.10  In patients diagnosed with AML at age 65 or older, the prognosis is poor.5

About Boehringer Ingelh
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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