CAMBRIDGE, Mass--Genzyme Corporation and Argus Pharmaceuticals, Inc. (The Woodlands, Texas) are cosponsoring a phase II/III clinical trial of Tretinoin(Drug information on tretinoin)LF in Kaposi's sarcoma patients. TretinoinLF is Argus' intravenous liposomal formulation of all-trans-retinoic acid.
In addition, Argus will soon begin a phase II study of TretinoinLF in patients with acute promyelocytic leukemia (see page 14 for a report on the FDA Oncologic Drugs panel's recommendation of Hoffmann-La Roche's Vesanoid brand of tretinoin).
Studies have shown that oral all-trans-retinoic acid is active in various cancers, but patients receiving the oral formulation have a high rate of relapse, and recent studies suggest that drug resistance to the oral form stems from a rapid clearance mechanism in humans that prevents the compound from remaining in the bloodstream at therapeutic levels.
Studies of TretinoinLF, presented at the American Society of Hematology meeting, showed that the liposomal formulation was well tolerated and produced sustained high drug blood levels in humans, the companies said.