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Shark Cartilage Sinks in Phase 3 Trial Among Lung Cancer Patients: Presented at ASCO

By Ed Susman

CHICAGO, IL -- June 3, 2007 -- In the first scientific study of its kind, shark cartilage extract, AE-941 (Neovastat), showed no benefit in treatment of patients with advanced non-small-cell lung cancer, researchers said here at the 43rd American Society of Clinical Oncology Annual Meeting (ASCO).

"Clearly, these results demonstrate that AE-941 is not an effective therapeutic agent for lung cancer," said Charles Lu, MD, associate professor of medical oncology, University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States. "So, too, these findings have to cast major skepticism on shark cartilage products that are being sold for profit and have no data to support their efficacy as cancer-fighting agent."

In a study that was curtailed due to slow enrollment, 384 patients with lung cancer were enrolled to receive chemoradiotherapy and purified shark extract or chemoradiotherapy and placebo.

Researchers said that after 3.7 years of follow-up, patients receiving shark cartilage survived an average of 14.4 months, and those who received the placebo, 15.6 months. "These differences did not reach statistical significance," Dr. Lu said.

"This is the first large phase 3 randomised trial of shark cartilage as a cancer agent," Dr. Lu said June 2nd in a press briefing sponsored by ASCO.

"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, of Montreal, Canada, developed the compound as a pharmaceutical as opposed to a compound sold for profit that is available over the Internet, for example," said Dr. Lu, the study's national principal investigator.

The absence of blood vessels in cartilage as well as preclinical studies analysing cartilage extracts 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 1 and 2 studies in lung and renal cancers suggested some benefit to patients when AE-941 was given at higher doses, said Dr. Lu.

The international phase 3 study enrolled patients with newly diagnosed, untreated stage III non–small-cell lung cancer at 53 sites in the United Sates and Canada from June 2000 to February 2006. M. D. Anderson enrolled 60 patients in the trial. The study was initiated at the request of, and was supported by, the National Cancer Institute, which sought proposals from pharmaceutical companies regarding their shark cartilage agents.

All study participants received the standard treatment of induction chemotherapy and chemoradiation. Patients were randomised to receive either shark cartilage or placebo, both in the form of a liquid. Patients drank 4 oz (0.1 kg) of the extract twice daily, and continued on the shark cartilage/placebo as maintenance after completing standard therapy.

[Presentation title: A Phase III Study of AE-941 With Induction Chemotherapy and Concomitant Chemoradiotherapy for Stage III Non-Small Cell Lung Cancer (NCI T99-0046, RTOG 02-07, MDA 99-303). Abstract 7526]

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