Access seeks clearance for phase I solid tumors trial
The compound, AP5346, utilizes Access' proprietary polymer drug delivery system to selectively deliver the cytotoxic DACH platinum to tumors. Upon receiving clearance from the FDA, Access plans to initiate a study of AP5346 in combination with two other cancer drugs, fluororuracil and leucovorin, in patients with progressive solid tumors. Access' initial AP5346 clinical study in the US is designed to evaluate the safety of AP5346 when used in combination with fluororuracil and leucovorin, and establish a starting dose for future phase II studies. On completion of this phase I study, Access plans to initiate a phase II combination study to determine the efficacy of AP5346 in combination with fluorouracil and leucovorin in colorectal cancer, compared with the oxaliplatin combination which is used extensively to treat colorectal cancer. Access is in the process of initiating a phase II study in Europe, to study the efficacy of AP5346 in patients with recurrent ovarian cancer. "This submission marks an important milestone for Access and our polymer drug delivery programs," said Kerry Gray, president and CEO of Access. "As reported previously, preliminary results from a phase I clinical study of AP5346 in Europe have shown that AP5346 is well tolerated and shows evidence of efficacy. Based on these encouraging findings, we are eager to pursue expanded clinical trials."