Arrowhead Research Corporation has announced that interim Phase I data has been published in the 2007 American Society for Clinical Oncology Proceedings.
The data are from an ongoing Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics of its lead anti-cancer drug candidate, IT-101 in patients with inoperable or metastatic tumors. IT-101 is a conjugate of the potent anti-cancer drug camptothecin and Insert's proprietary drug delivery technology, Cyclosert™.
"The interim IT-101 study results look very promising," stated R. Bruce Stewart, Chairman of Arrowhead. "We were encouraged to see patients who have failed other chemotherapies complete the whole six cycles of treatment without disease progression."
The abstract's authors state that the stable disease rate, although not yet conclusive, is consistent with promising efficacy. In general, IT-101 was well tolerated and pancytopenia was the dose limiting toxicity.
Patients that have completed the six cycle treatment regimen and showed stable disease or better are expected to continue to receive treatment on a compassionate care basis. The first person to enter the trial, a pancreatic cancer patient, is stable after 10 months.
"The type of dose limiting toxicity identified is consistent with the expectation for a camptothecin derivative," said Dr. Thomas Schluep, Chief Scientific Officer at Insert. "We are encouraged that, at dose levels that have promising efficacy, we have not seen some of the other deleterious side effects commonly experienced by patients receiving camptothecin class drugs."
Pharmacokinetics data were favorable and consistent with results from preclinical animal studies. In the patients studied, IT-101 showed longer half life, lower clearance and lower volume of distribution than seen in patients treated with other camptothecin-based drugs.
The study is ongoing and Insert expects to enter Phase II studies later this year or early next year.
"It is gratifying to see that the Cyclosert system is working as designed in patients," said Dr. Mark Davis, inventor of the technology and Insert's Scientific Founder. "We are looking forward to completing this trial and moving into multiple Phase II studies."