Liposomal Tretinoin in Phase II/III Trials in Kaposi's Sarcoma Patients

CAMBRIDGE, Mass--Genzyme Corporation and Argus Pharmaceuticals,Inc. (The Woodlands, Texas) are cosponsoring a phase II/III clinicaltrial of TretinoinLF in Kaposi's sarcoma patients. TretinoinLFis Argus' intravenous liposomal formulation of all-trans-retinoicacid.

In addition, Argus will soon begin a phase II study of TretinoinLFin patients with acute promyelocytic leukemia (see page 14 fora report on the FDA Oncologic Drugs panel's recommendation ofHoffmann-La Roche's Vesanoid brand of tretinoin).

Studies have shown that oral all-trans-retinoic acid is activein various cancers, but patients receiving the oral formulationhave a high rate of relapse, and recent studies suggest that drugresistance to the oral form stems from a rapid clearance mechanismin humans that prevents the compound from remaining in the bloodstreamat therapeutic levels.

Studies of TretinoinLF, presented at the American Society of Hematologymeeting, showed that the liposomal formulation was well toleratedand produced sustained high drug blood levels in humans, the companiessaid.