LTI Reports DOX-SL Trial Results

Results of a Phase II/III study, reported at the AIDS conference in Yokohama, Japan, indicate that Liposome Technology Inc's DOX-SL (liposomal doxorubicin) is an effective treatment for AIDS-related Kaposi's sarcoma. The data came from a multicenter European and Australian study involving 247 patients. LTI plans to file for marketing approval for DOX-SL in the USA shortly.

Data from 133 of the patients, who had moderate-to-severe KS, were available for evaluation at the time of the AIDS meeting. The patients received six cycles of treatment with DOX-SL, administered at two week intervals at doses of 10mg/m2, 20mg/m2 and 40mg/m2. Three of the patients (2.3%) achieved a complete response and 81 (60.9%) had a partial response to DOX-SL therapy. 28.6% of the 133 patients had stable disease after six cycles of DOX-SL therapy and 8.3% showed disease progression.

The researcher who presented the results, Simon Stewart of St Mary's Hospital in London, UK, noted that DOX-SL was well-tolerated, and that its toxicity was probably lower than that seen with conventional doxorubicin. 25% of patients experienced nausea and 14% had vomiting. Other common side effects were stomatitis (11%), constipation (8%), diarrhea (24.9%) and alopecia (12%). Grade 3 or 4 granulocytopenia occurred after only a minority of cycles, but may affect approximately half of all patients, noted Dr Stewart.