Aronex' Atragen Set For Filing End-97

Aronex Pharmaceuticals has presented encouraging clinical data with itsnovel formulation of tretinoin, Atragen, in acute promyelocytic leukemia and Kaposi's sarcoma, and plans to file for approval of the drug in APL by the end of the year, according to company president James Chubb.

Aronex has also revised its agreement for the development of Atragen with Genzyme. Genzyme's rights to the product have now been converted to an option to commercialize Atragen, should it come to market. Aronex has copromotion rights to the drug in the USA and will receive royalties on sales.

Preliminary safety data from a Phase II study of the drug have shown that it was well-tolerated at the high doses used, and that 100% of the first-relapse patients treated to date have achieved complete remission. Meanwhile, interim data from a Phase II/III trial in AIDS patients with Kaposi's sarcoma has shown that the drug is well-tolerated up to a dose of 120mg/m2 given three times a week. Out of a subset of 13 patients treated at this highest dose, one achieved a complete response, six had a partial response or stable disease, and six showed progressive disease.