Bayer to Present New Data Evaluating Investigational Oncology Compounds at 2011 ECCO-ESMO Congress

-- Full results of Phase III radium-223 chloride trial being presented in Presidential Session I: Best and Late Breaking Abstracts

-- Phase II trial results evaluating Regorafenib in multiple tumor types

Sep 13, 2011, 02:00 ET from Bayer HealthCare

WAYNE, N.J., Sept. 13, 2011 /PRNewswire/ -- Bayer HealthCare announced today that the company will present data on several of its investigational compounds at the 2011 European Multidisciplinary Cancer Congress (ECCO-ESMO), September 23-27, 2011, in Stockholm, Sweden. These presentations, including the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) data evaluating radium-223 chloride in patients with castration-resistant prostate cancer (CRPC), will highlight the potential of Bayer's growing oncology pipeline.

"We look forward to presenting the complete Phase III data on radium-223 chloride for the first time following the positive results from the ALSYMPCA interim analysis released earlier this year," said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. "These data, along with other presentations from our oncology pipeline, serve to demonstrate Bayer's commitment in cancer."

Studies evaluating Bayer's investigational oncology compounds being presented at ECCO-ESMO include:

Radium-223 Chloride

  • LATE BREAKING ABSTRACT: Overall Survival Benefit of Radium-223 Chloride (Alpharadin™) in the Treatment of Patients with Symptomatic Bone Metastases in Castration-resistant Prostate Cancer (CRPC): a Phase III Randomized Trial (ALSYMPCA)
    • Presidential Session I: Best and Late Breaking Abstracts
    • Saturday, September 24, 2011, 2:35pm CEST, Hall A1

A separate 24-month safety analysis from Phase II studies of radium-223 chloride will be presented at the meeting as a poster discussion (Abstract #7008, Poster Discussion Session: Genitourinary Malignancies – Prostate Cancer, Monday, September 26, 2011, 11:00am-12:00pm CEST, Hall A8).

Regorafenib (BAY 73-4506)

  • Phase II Trial of the Oral Multikinase Inhibitor Regorafenib (BAY 73-4506) as First-line Therapy in Patients With Metastatic or Unresectable Renal Cell Carcinoma (RCC)       
    • Abstract # 7141, Poster Session: Genitourinary Malignancies - Other
    • Sunday, September 25, 2011, 2:00-4:30pm CEST, Poster Area  

  • Phase II Safety Study of the Oral Multikinase Inhibitor Regorafenib (BAY 73-4506) as Second-line Therapy in Patients With Hepatocellular Carcinoma
    • Abstract # 6576, Poster Session: Gastrointestinal Malignancies - Non-colorectal Cancer
    • Monday, September 26, 2011, 9:30am-12:00pm CEST, Poster Area

About Radium-223 Chloride

Radium-223 chloride is an investigational pharmaceutical containing an alpha-particle emitting nuclide in development for cancer patients with bone metastases. In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of radium-223 chloride. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally, while Algeta retains an option for up to 50/50 co-promotion and profit-sharing in the United States.

Radium-223 chloride is an investigational agent and is not approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other Health Authorities.  It was granted fast track designation by the FDA in August 2011.

About Regorafenib

Regorafenib is an investigational oral multi-kinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases (TK)(i) currently being investigated in clinical trials for its potential to treat patients with various tumor types.

Regorafenib is an investigational agent and is not approved by the FDA, EMA or other Health Authorities.  

About Oncology at Bayer

Bayer is committed to advancing the science of cancer, and translating this science into therapies that can help people with cancer live longer.  With several compounds in clinical development, Bayer's oncology portfolio demonstrates the Company's commitment to improving the lives of people living with cancer.

About Bayer HealthCare Pharmaceuticals Inc.

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, Diabetes Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, 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.

Contact:
Heather Levis, Tel. +1 973 305 5313
E-Mail: heather.levis@bayer.com

Forward-Looking Statements

This 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.

(i) S. Wilhelm, et al.  Regorafenib (Bay 73-4506): A New Oral Multikinase Inhibitor Of Angiogenic, Stromal, And Oncogenic Receptor Tyrosine Kinases With Potent Preclinical Antitumor Activity.  Online International Journal of Cancer.  December 17, 2010.

SOURCE Bayer HealthCare



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