IT-101 is an experimental, nanoparticle therapeutic that consists of the drug camptothecin conjugated to a cyclodextrin polymer. IT-101, the first drug candidate in Calando’s proprietary Cyclosert pipeline, has now successfully completed a Phase I trial designed to evaluate its safety, tolerability and pharmacokinetics in patients with inoperable or metastatic tumors.
Initially, the trial utilized a weekly dosing schedule. However, because of the excellent pharmacokinetic characteristics observed for the drug, including a half-life of approximately 40 hours, a subsequent Phase Ib was conducted utilizing a twice monthly dosing schedule, the company said.
The Phase Ia and Phase Ib studies are now completed, and all trial endpoints have been successfully achieved. The drug was found to be well tolerated in both the Phase Ia and Ib studies of the trial.
A high proportion of patients displayed stable disease following treatment thereby showing evidence of IT-101’s cytostatic activity. Based on these Phase I results, Calando has initiated a multi-center Phase II clinical trial in ovarian carcinoma patients. The Phase II trial is designed to determine whether IT-101 treatment can delay disease progression in stable disease patients who have completed a standard second line course of platinum chemotherapy.
Calando said that the successful completion of the IT-101 Phase I study opens numerous avenues for its further clinical investigation. In addition to the Phase II trial in ovarian cancer, other clinical trials, including testing IT-101 in lymphoma patients, are planned.