Bayer Announces New Data on Novel Anti-cancer Compound B... ( Data Presented at 45th American Socie...)

Bayer Announces New Data on Novel Anti-cancer Compound BAY 73-4506

Date:5/30/2009

Data Presented at 45th American Society of Clinical Oncology Annual Meeting

Abstracts: 5033, 3560

ORLANDO, Fla., May 30 /PRNewswire/ -- Bayer today announced results from Phase I and II trials of BAY 73-4506, a potent oral multi-kinase inhibitor currently being studied in multiple tumor types. These data were presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).

"Bayer is committed to discovering new cancer-fighting therapies," said Kemal Malik, MD, Chief Medical Officer and Head of Global Development at Bayer HealthCare. "We are encouraged by these Phase I and II data being presented on BAY 73-4506. These data will help further determine our next steps as we move forward with a comprehensive Phase III clinical development program in various tumor types for this new drug candidate."

Preliminary data from the Phase II, open-label study in renal cell carcinoma (RCC) demonstrated a 27 percent partial response (PR) rate according to the Response Evaluation Criteria in Solid Tumors (RECIST) and a disease control rate of 79 percent. The most common drug-related adverse events were hand-foot skin reaction (HFSR), fatigue, hypertension, mucositis, dysphonia, rash, diarrhea, and anorexia. The Phase II study enrolled 49 previously untreated patients with predominantly clear cell RCC. BAY 73-4506 (160 mg) was administered once daily on a three weeks on/one week off schedule. The primary endpoint was to evaluate response rate according to RECIST.

"We are encouraged by these data of BAY 73-4506," said lead investigator Professor Tim Eisen, F.R.C.P., PhD, of Addenbrooke's Hospital at the University of Cambridge, UK. "These data provide a rationale to move into a Phase III trial in one of the multiple tumor types that may be responsive to BAY 73-4506."

Additional data presented on BAY 73-4506 include a Phase I study
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