AE 941 is shark cartilage extract which inhibits angiogenesis. It is being developed by AEterna Laboratories in Canada as NeovastatTMfor the treatment of cancer. Phase I/II Canadian and US trials of NeovastatTMhave been completed for the treatment of refractory lung cancer (n = 80) and are ongoing for the treatment of breast and prostate cancers. AEterna has signed a Clinical Trials Agreement (CTA) with the National Carter Institute (NCI) for the realisation of a pivotal phase III clinical trial of AE 941 for the treatment of non-small-cell lung cancer in combination with chemo/radiotherapy. The trial is expected to begin in the second quarter of 1999 and will enrol over 550 patients in the US and Canada. AEterna Laboratories has agreed to a limited distribution of AE 941 to Canadian doctors who request it from the Health Protection Branch for the treatment of patients with refractory conditions. AE 941 is also being developed for other indications by AEterna.AE 941 is the first anticancer agent derived from shark cartilage to demonstrate efficacy without serious adverse events in patients with solid tumours. AE 941 is a promising drug candidate as a first-line treatment for cancer in combination with current therapy.