Bayer Schering Pharma Initiates Phase III Trial of Regorafenib in Metastatic Colorectal Cancer

Bayer Schering Pharma Initiates Phase III Trial of Regorafenib in Metastatic Colorectal Cancer
 
 
Berlin, May 7, 2010 - Bayer Schering Pharma AG, Germany, today announced that the company has started to enroll patients in an international Phase III trial to evaluate its investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies. Regorafenib is a potent oral multi-kinase inhibitor with a kinase inhibition profile targeting angiogenic, stromal and oncogenic receptor tyrosine kinases.

"There are very few treatment options available to patients with colorectal cancer whose disease has progressed following treatment with existing therapies," said Kemal Malik, MD, Member of the Board of Management of Bayer Schering Pharma AG and Head of Global Development. "The initiation of a Phase III clinical trial for regorafenib marks the starting point for a potential new treatment option for colorectal cancer patients, and is an important milestone for Bayer in our ongoing effort to meet the unmet needs of people affected by cancer."

About the Phase III Study
The CORRECT (Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial is an international, multicenter, randomized, double-blind, placebo-controlled study that will enroll approximately 690 patients with metastatic CRC who have progressed after standard therapies. Patients will be randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Treatment cycles will consist of 160 mg of regorafenib (or matching placebo) once daily for three weeks/one week off plus BSC. The primary endpoint of this trial is overall survival, and secondary endpoints include progression-free survival, objective tumor response rate and disease control rate. The safety and tolerability of the two treatment groups will also be compared.

The study will be conducted in North America, South America, Europe, Israel, Asia and Australia. For information about this study, please visit www.clinicaltrials.gov.

About Colorectal Cancer
Colorectal cancer (CRC) is a disease in which malignant (cancer) cells form in the tissues of the colon or rectum. The majority of cancers occurring in the colon and rectum are adenocarcinomas, which account for more than 90 percent of all large bowel tumors.

CRC is the second most prevalent cancer worldwide, with over one million cases occurring every year. The mortality rate from CRC is approximately half of its global incidence. Five-year survival estimates for CRC in men have been reported to be 65 percent in North America and 54 percent in Western Europe.

About Regorafenib
Regorafenib is a new potent oral multi-kinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases. Regorafenib inhibits angiogenic kinases like receptors for VEGF and the TIE2 receptor which play a central role in angiogenesis. It also inhibits various oncogenic kinases like RAF, RET and c-KIT, thereby helping to stop the proliferation of cancer cells. Regorafenib has shown potent antitumor activity in preclinical studies by inhibiting tumor growth in multiple xenograft models via antiangiogenic and antiproliferative mechanisms. Based on these results regorafenib is currently being investigated in clinical trials for its potential to treat patients with various tumor types. Promising clinical activity of regorafenib was recently shown in Phase I and II clinical studies.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover, manufacture and market products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.


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.

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