RIDGEFIELD, Conn., Nov. 29, 2012 /PRNewswire/ -- Boehringer Ingelheim today announced that new data evaluating volasertib, an investigational polo-like kinase (Plk) inhibitor, will be presented at the 54^th American Society of Hematology (ASH) annual meeting taking place December 8-11 in Atlanta, Ga.  Data include results from the Phase II portion of a Phase I/II study evaluating volasertib administered in addition to low-dose cytarabine (LDAC) compared to LDAC monotherapy in newly diagnosed acute myeloid leukemia (AML) patients ineligible for intensive treatment.¹  Additionally, volasertib pre-clinical data in refractory pediatric leukemia cells will be presented.²

"Boehringer Ingelheim is looking forward to presenting the results for volasertib, a late-stage developmental compound in our growing oncology pipeline," said Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc.  "The results add to a growing body of knowledge for volasertib and merit further investigation in this difficult-to-treat patient population with acute myeloid leukemia (AML)."

Abstract details for each study are provided below:

Presentations of Boehringer Ingelheim Investigational Oncology Compound Volasertib at ASH 2012 Annual Meeting

The Phase II results -- from the Phase I/II study that will be presented at ASH -- support the initiation of the Phase III POLO-AML-2 study (NCT01721876), which is designed to assess the efficacy and safety of volasertib in combination with LDAC compared to LDAC.  The planned Phase III trial will enroll eligible patients aged 65 or older with previously untreated AML, who are ineligible for intensive remission induction therapy.³

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.

Volasertib represents the company's most advanced cell cycle kinase inhibitor program.  Boehringer Ingelheim is one of the first companies to advance Plk inhibitors into clinical development.

Volasertib is designed to inhibit the activity of Plk1 and thereby inhibit its ability to regulate cell division (mitosis).  This inhibition is intended to result in prolonged cell cycle arrest and ultimately cell death (apoptosis).⁴

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

About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to develop innovative cancer treatments. Working in close collaboration with the international scientific community and a number of the world's leading cancer centers, Boehringer Ingelheim's commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumors and hematological cancers.  The current focus of late-stage research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition.

For information about participating in a Boehringer Ingelheim clinical trial, please visit www.bicancertrials.com or call 1.866.725.7110. Healthcare providers interested in learning more about Boehringer Ingelheim clinical trials in oncology can visit www.inoncologyus.com for additional information.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

References

1. Maertens J et al, Phase I/II study of volasertib (BI 6727), an intravenous Polo-like kinase (Plk) inhibitor, in patients with acute myeloid leukemia (AML): results from the randomized phase II part for volasertib in combination with low-dose cytarabine (LDAC) versus LDAC monotherapy in patients with previously untreated AML ineligible for intensive treatment. Abstract, ASH Annual Meeting and Exposition 2012, available at: https://ash.confex.com/ash/2012/webprogram/Paper50682.html  [Last Accessed: November 13, 2012] 
2. Jayanthan A et al, Cooperative Lethality of Polo-Like Kinases (Plk) and Aurora Kinases (AK) in Refractory Pediatric Leukemia. Abstract, ASH Annual Meeting and Exposition 2013. Available at: https://ash.confex.com/ash/2012/webprogram/Paper55261.html  
3. ClinicalTrials.gov.  Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy.  ClinicalTrials.gov Identifier: NCT01721876. Accessible here: http://clinicaltrials.gov/ct2/show/NCT01721876?term=1230.14&rank=1 [Last Accessed: November 13, 2012] 
4. Schoffski P.  Polo-Like Kinase (PLK) Inhibitors in Preclinical and Early Clinical Development in Oncology.  Oncologist. 2009;14(6):559-570.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.