Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. have initiated a randomized, double-blind, placebo-controlled Phase III clinical trial of BAY 43-9006 administered as a single agent in patients with advanced hepatocellular carcinoma (HCC), or liver cancer.

BAY 43-9006, a novel RAF kinase and VEGFR inhibitor under investigation for the treatment of different types of cancer, combines two anticancer activities: inhibition of tumour cell proliferation and angiogenesis (the growth of new blood vessels). BAY 43-9006 is being evaluated in several clinical trials, including a Phase III randomized clinical trial for the treatment of renal cell carcinoma (RCC), or kidney cancer.

"BAY 43-9006 is the first raf kinase inhibitor to be tested in a worldwide HCC Phase III study," Dr. Jordi Bruix, Head of the Barcelona Clinic Liver Cancer Group (BCLC), University of Barcelona, Spain said adding, "Based on the results seen in the Phase II HCC studies, we are pleased to continue the clinical development of BAY 43-9006 in liver cancer, a difficult-to-treat patient population. HCC is a particularly aggressive type of cancer with a significant unmet treatment need. Because of this, it is vitally important to pursue research to develop potential new therapies for this disease."

The Phase III study is designed to measure differences in overall survival, time to symptom progression and time to tumor progression of BAY 43-9006 versus placebo in patients with advanced HCC. The trial will also evaluate the safety and pharmacokinetics of BAY 43-9006.

In the Phase II advanced HCC study, safety data generated showed that BAY 43-9006 was well tolerated and side effects were predictable and manageable. The most common grade 3/4 drug-related toxicities were fatigue (9.5 per cent), diarrhoea (8 per cent), and hand-foot skin reaction (5 per cent).

Bayer and Onyx also reported today that the US FDA has completed a Special Protocol Assessment (SPA) for the Phase III HCC trial. An SPA is a written agreement on the design and size of clinical trials intended to form the basis for a new drug application.

The companies are also planning a Phase II trial for liver cancer patients to evaluate the use of BAY 43-9006 in combination with the chemotherapeutic agent doxorubicin.

BAY 43-9006, a novel investigational drug candidate, has demonstrated anti-proliferative and anti-angiogenic properties - two important anticancer activities.