A clinical trial to rigorously evaluate a shark cartilage extract as a cancer treatment found no benefit for patients with non-small cell lung cancer. Patients who took the extract, AE-941 or Neovastat, along with chemotherapy and radiation therapy lived no longer than patients who did not, according to a report published online May 26 in the Journal of the National Cancer Institute. Negative results from the study were first reported at the American Society of Clinical Oncology (ASCO) annual meeting in 2007.

The phase III randomized placebo-controlled clinical trial was cosponsored by NCI and the National Center for Complementary and Alternative Medicine. The study closed early because of slow patient accrual. Only 379 eligible patients were included in the final analysis. “It is, nevertheless, the largest phase III study ever conducted, to our knowledge, of a shark cartilage–derived agent, and the study outcome is unambiguous,” the researchers noted. The manufacturer of AE-941, Canadian pharmaceutical company Æterna Laboratories, worked closely with the investigators to ensure the purity of the extract used in the trial.

In a separate editorial about the study results, Dr. Jeffrey White, director of the NCI Office of Cancer Complementary and Alternative Medicine, noted, “This study was well designed and conducted and has gener­ated important and useful findings with regard to one specific product, AE-941.” Dr. White cautioned against concluding that the study “completely disproved the efficacy of shark cartilage” or other natural materials for treating cancer. “The potential value of complex mixtures of nat­ural materials in the anticancer armamentarium remains an open question for many and one that can only be answered one step at a time with high-quality research,” he wrote.