Bayer HealthCare Devises Phase III Plans for Top Prospect

WHIPPANY, N.J., April 14, 2015 /PRNewswire/ -- Bayer HealthCare today announced the expansion of its global clinical development program for the investigational oncology compound copanlisib (BAY 80-6946), which now includes two new Phase III studies in indolent non-Hodgkin's lymphomas (NHL) and one additional Phase II study in diffuse large B-cell lymphoma (DLBCL), an aggressive subtype of NHL.

Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against both PI3K- and PI3K- isoforms. The PI3K pathway is one of the most frequently altered pathways in cancer and the PI3K isoforms trigger many cellular functions such as growth control, metabolism and transcription initiation. Copanlisib is one of the company's key pipeline assets currently in development.

"This is a major step forward in our commitment to exploring the full clinical potential of copanlisib for patients with NHL," said Dario Mirski, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.   "Non-Hodgkin's lymphoma is a highly heterogenous disease characterized by a chronic pattern of remissions and recurrences, and for NHL patients with disease recurrence after initial treatment, there are limited treatment options. Therefore, we are committed to investigating potential therapies to address the unmet need of patients."

Three new studies will open for enrollment by mid-2015 to investigate the efficacy and safety of copanlisib in patients with recurrent indolent NHL and diffuse large B-cell lymphoma (DLBCL), an aggressive subtype of NHL.  The expanded clinical program will now include:

• CHRONOS-2: A Phase III randomized, double-blind, placebo-controlled study of copanlisib in rituximab refractory indolent NHL patients who have previously been treated with rituximab and alkylating agents (NCT02369016)
• CHRONOS-3: A Phase III randomized, double-blind study evaluating the efficacy and safety of copanlisib in combination with rituximab versus rituximab monotherapy in patients with relapsed iNHL who have received at least one prior line of treatment, including rituximab and an alkylating agent (NCT02367040)
• A Phase II open-label, single arm study in patients with relapsed or refractory DLBCL to evaluate the efficacy and safety of copanlisib and assess the relationship between efficacy and potentially predictive biomarkers (NCT02391116)

Information about the trials can be found at www.clinicaltrials.gov and www.chronostrials.com.

Copanlisib was recently granted orphan drug designation by the FDA Office of Orphan Products Development (OOPD) for investigation in follicular lymphoma, a histologic subtype of NHL.  The Orphan Drug Designation program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the US, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.[1]

Copanlisib is an investigational agent and is not approved by the FDA, EMA or other health authorities.

About Oncology at Bayer
Bayer is committed to delivering Science for a BetterLife by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer HealthCare Pharmaceuticals
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals Inc. provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

BAYER and the Bayer Cross are registered trademarks of Bayer.               

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

[1] http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525.htm

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SOURCE Bayer HealthCare