The phase I trial will be an open-label, dose-escalation clinical trial of IT-101 in patients with all types of cancer. The trial is expected to enroll between 24 and 48 patients and has been designed to determine the safety and tolerability of the compound.
IT-101 is a nanotechnology-based therapeutic that combines Insert’s patented Cyclosert technology and the anticancer compound camptothecin.
According to the company, analogues of camptothecin, such as irinotecan and topotecan, realize nearly $1 billion in worldwide sales annually, despite the numerous unwanted side effects of these medications.
In preclinical animal studies conducted by Insert, treatments with IT-101 appear to be substantially more effective, resulting in protracted anti-tumor activities, at significantly lower doses than all other treatments, including those with irinotecan. In some tumor types, IT-101 has caused complete remission of tumors.
“FDA clearance to begin clinical trials is another significant milestone for Insert on the road to becoming a leader in nanotechnology-based therapeutics,” said R Bruce Stewart, Arrowhead’s chairman. “This accomplishment reflects Insert’s capability and commitment to commercialize the Cyclosert platform for cancer and other diseases.”