Davanat is a proprietary polysaccharide in a Carbosome formation that enables the targeted delivery of chemotherapy drugs to protein receptors (lectins) that are unique to cancer cells.
The phase I trial was designed for cancer patients with advanced solid tumors that were not amenable to surgery, radiation, or chemotherapy. The objectives of the study are to determine the maximum tolerated dose and dose limiting toxicity of Davanat as a single agent, and when administered in combination with 5-FU; to determine the pharmacokinetic profile of 5-FU in the presence of Davanat; and, to determine the effect of Davanat/5-FU on tumor size.
The data show dose limiting toxicity (DLT) was not reached when Davanat is administered alone or in combination with 5-FU at the highest dose level in the sixth and final cohort of phase l.
Of the first 25 patients enrolled in the phase l trial through November 2004, 20 have completed the study. Of these patients, 45% had stable disease, 45% had progressive disease and 10% had disease that was un-measurable. Pro-Pharmaceuticals is currently finalizing a phase I trial expecting to evaluate up to 40 patients.