In the first scientific study of its kind, shark cartilage extract, AE-941 or Neovastat, has shown no benefit as a therapeutic agent when combined with chemotherapy and radiation for patients with advanced non-small cell lung cancer, according to researchers at The University of Texas MD Anderson Cancer Center.
The study was published in the Journal of the National Cancer Institute; the findings were first presented at the 43rd annual meeting of the American Society of Clinical Oncology.
The absence of blood vessels in cartilage as well as preclinical studies analyzing cartilage extracts have supported the hypothesis that cartilage contains inhibitors of angiogenesis. Also, shark cartilage has long intrigued the public due to the belief that the incidence of cancer in this cartilaginous fish is very rare. Early Phase I and II studies in lung and renal cancers suggested some benefit to patients when AE-941 was given at higher doses, said Charles Lu, M.D. associate professor in MD Anderson's Department of Thoracic Head and Neck Medical Oncology.
"This is the first large Phase III randomized trial of shark cartilage as a cancer agent. A unique and important aspect about this shark cartilage study was that this product, Neovastat, was never sold over-the-counter, unlike other shark cartilage compounds previously studied. The company, Aeterna Zentaris, developed the compound as a pharmaceutical as opposed to a compound sold for profit that is available over the Internet, for example," said Lu, the study's national principal investigator and corresponding author.
The international Phase III study enrolled 379 newly-diagnosed untreated Stage III non-small cell lung cancer patients at 53 sites in the United Sates and in Canada from June 2000 to February 2006. MD Anderson enrolled 60 patients in the trial.
The study was initiated at the request of, and was supported by, the National Cancer Institute (NCI) who sought proposals from pharmaceutical companies regarding their shark cartilage agents.
All study participants received the standard treatment of induction chemotherapy and chemo-radiation. Patients were randomized to receive either shark cartilage or placebo, both in the form of a liquid. Patients drank four ounces of the extract twice daily, and continued on the shark cartilage/placebo as maintenance after completing standard therapy.