Bayer Schering Pharma AG, Germany, today announced that data from Phase I and II studies evaluating two of the company’s late-stage pipeline cancer treatments – Alpharadin (radium-223 chloride) and regorafenib (BAY 73-4506) – will be presented at the 35th European Society for Medical Oncology (ESMO) Congress, October 8-12, 2010, in Milan, Italy.
Alpharadin is currently in a global Phase III clinical trial (ALSYMPCA) in patients with castration-resistant prostate cancer (CRPC) whose cancer has spread to the bone. The primary endpoint of the Phase III trial is overall survival. Alpharadin is a first-in-class alpha-pharmaceutical (alpha-emitting nuclide) that mimics many of the behaviors of calcium in the body. In Phase II trials, Alpharadin showed a statistically significant improvement in overall survival (OS) compared to placebo, a consistent improvement in disease-related biomarkers and pain, and a favorable side-effect profile.
Regorafenib is an investigational anti-cancer drug with a distinct profile targeting angiogenic (VEGFR, TIE-2), stromal (PDGFR-β) and oncogenic (RAF, RET and c-KIT) receptor tyrosine kinases. Regorafenib is currently being evaluated in a large global Phase III trial as a potential treatment for patients with heavily pretreated, advanced colorectal cancer (CRC).
“Despite advances in cancer treatment, patients are still in need of new therapies that improve on and work differently from existing therapies, particularly in late-stage and difficult-to-treat disease. At Bayer, we are committed to researching and developing potential anti-cancer therapies like Alpharadin and regorafenib, in order to provide patients with new treatment options,” said Rob Rosen, Head Global Oncology, Bayer Schering Pharma. “We are pleased to highlight some of the data that advanced both Alpharadin and regorafenib, and look forward to the results from our ongoing Phase III trials, which we believe could potentially lead to promising new treatment options for a variety of cancer patients.”
Alpharadin data presented at the meeting include:
• Radium-223 chloride, a novel, highly targeted, alpha-pharmaceutical for treatment of bone metastases from castration-resistant prostate cancer and bone metastases: hematologic and safety profile with repeated dosing (Phase I and II)
– Christopher Parker, MD, The Institute of Cancer Research, Royal Marsden Hospital, London, UK
– Abstract #887, Poster Presentation I
– Saturday, October 9, 1:00 pm – 2:00 pm CET, Hall 3
Regorafenib data presented at the meeting include:
• Analysis of plasma biomarkers, DCE-MRI and KRAS mutations in patients with advanced colorectal carcinoma treated with the multikinase inhibitor regorafenib (Phase I)
– Olaf Christensen, Bayer HealthCare, Montville, NJ, USA
– Abstract #619, Poster Presentation II
– Sunday, October 10, 12:30 pm –1:30 pm CET, Hall 3
• Identification of plasma biomarkers for the multikinase inhibitor regorafenib (BAY 73-4506) in patients (pts) with renal cell cancer (Phase II)
– Michael Jeffers, Bayer HealthCare, Montville, NJ, USA
– Abstract #123, Poster Presentation III
– Monday, October 11, 12:30 pm –1:30 pm CET, Hall 3.