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Bayer start trial for GIST tumour treatment

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Berlin, January 10, 2011 – Bayer HealthCare, Germany, today announced that the company has started to enroll patients in GRID, an international Phase III trial to evaluate its investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumours (GIST) whose disease has progressed after at least imatinib and sunitinib as prior treatments.

Regorafenib is an oral multi-kinase inhibitor with a distinct profile targeting angiogenic (VEGFR, TIE-2), stromal (PDGFR-β) and oncogenic (RAF, RET and KIT) receptor tyrosine kinases.

“This Phase III trial was designed based upon strong signals of clinical activity seen in an academically-designed, non-randomized, single-arm Phase II trial in GIST patients whose disease had exhausted all standard treatment options,” said George Demetri, MD, Director, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Chair of the Steering Committee for this trial.

“Metastatic GIST remains a life-threatening disease for the majority of patients, despite the revolutionary advances over the past decade with molecular-targeted therapy with imatinib and sunitinib, which are the only two agents approved by regulatory authorities for GIST treatment.”

About the Phase III Study
GRID is a randomized, double-blind, placebo-controlled, multi-centre, cross-over Phase III study of regorafenib (BAY 73-4506) for the treatment of GIST.

It will enrol approximately 170 patients whose cancer has progressed following initial treatment with at least imatinib and sunitinib as prior treatment regimens.

Patients will be randomized in a 2:1 ratio to receive either regorafenib 160mg once daily, three weeks on/one week off or placebo.

Subjects receiving placebo who experience disease progression will be offered open label regorafenib treatment (cross over option).

The primary endpoint of this trial is progression-free survival (PFS), and secondary endpoints include overall survival (OS), time to progression (TTP), disease control rate (DCR), tumour response rate (RR), duration of response (DOR), and safety.

All patients will enter the Survival Follow-Up Period upon discontinuation of study treatment, during which assessment of survival status will be performed every three months.

“Currently, there are limited treatment options available for patients whose GIST tumors have progressed after imatinib and sunitinib,” said Kemal Malik, MD, Member of the Board of Management of Bayer Schering Pharma AG and Head of Global Development.

“Bayer is committed to its ongoing efforts to improve the lives of people with cancer, and the initiation of a Phase III clinical trial for regorafenib is a critical step towards a potential new treatment option for GIST patients.”

For information about this study, please visit www.clinicaltrials.gov.



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