Bayer HealthCare Pharmaceuticals, Inc and Onyx Pharmaceuticals, Inc announced the start of a phase-III study with Nexavar (sorafenib) tablets in liver cancer. The randomized, double-blind, placebo-controlled study is evaluating Nexavar as an adjuvant therapy for patients with hepatocellular carcinoma (HCC), or primary liver cancer. An adjuvant treatment is given as an additional systemic therapy after the initial tumour treatment, e.g. surgery, to fight cancer cells that may have spread.
The STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial aims to further build on earlier phase-III data, which demonstrated a significant improvement in overall survival in patients with unresectable liver cancer. Based on the strength of these data, Nexavar was approved for HCC in the U.S. and Europe at the end of 2007.
"Nexavar is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations," said Dimitris Voliotis, vice-president, Nexavar Clinical Development, Bayer HealthCare. "Liver cancer is the third largest global cause of cancer-related deaths worldwide and there is a significant need for new therapies that can be used at all stages in the course of the disease to delay progression and prolong life."
In addition, the US Food and Drug Administration (FDA) has completed a Special Protocol Assessment (SPA) for the trial. An SPA is a written agreement between the FDA and the company that the design and size of a clinical trial are acceptable to support a New Drug Application for marketing in the United States.
Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumours in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally.
Nexavar targets both the tumour cell and tumour vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar (sorafenib) tablets, a small molecule drug.
The Bayer Group is a global enterprise with core competencies in the fields of health care, 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.