IVAX' oral paclitaxel shows promise in Ph II

IVAX has announced results from a Phase II clinical trial whichdemonstrated that its generic version of Bristol-Myers Squibb's anticancer drug Taxol (paclitaxel) may be as effective a treatment for advanced lung cancer as the various combinations of intravenous drugs currently used to treat the disease, and also offer greater convenience and fewer side effects.

Results showed that Onxol gave a 26% cancer regression rate (six partial responses in 23 evaluable patients). Five of the six responding patients received oral paclitaxel as a second-line therapy after having developed progression of their cancer despite prior intravenous chemotherapy. Eight additional patients had some stabilization of their cancer. Premedication requirements and adverse events were eliminated due to the absence of cremophor, which can cause allergic reactions, in the oral formulation.

IVAX' Onxol (6mg/ml injection), which is marketed by Zenith Goldline Pharmaceuticals, was approved last year by the US Food and Drug Administration as an intravenous therapy for breast and ovarian cancer. The company was given a 180-day market exclusivity period (Marketletter September 25, 2000), which has now expired. However, IVAX' oral delivery method was issued with a US patent earlier this year.