Insert Therapeutics to Initiate a Multinational Phase II Clinical Trial of Lead Drug Candidate IT-101

Insert Therapeutics, Inc. has that it has filed with the U.S. Food and Drug Administration to initiate a Phase II clinical trial evaluating the safety and efficacy of its drug candidate, IT-101 in patients with ovarian cancer.

In women who receive a 2nd course of chemotherapy, nearly 75% will achieve some degree of disease stabilization. However, most will experience a recurrence of their cancer within 9 to 12 months after treatment. For these women, the current standard care is to "watch and wait" until disease progression occurs.

The Insert Therapeutics Phase II study utilizes a design intended to demonstrate prolonged time until disease progression in patients who achieved a response or stabilization in their disease following a 2nd line course of platinum-based chemotherapy. Since there are no approved maintenance treatments following chemotherapy for ovarian cancer, this study will be the first of its kind. Patients will begin the experimental therapy shortly after chemotherapy is completed.

The study will enroll 150 patients in the United States and Eastern Europe, and will be led by Jonathan S. Berek MD, MMS, Professor and Chair, Department of Obstetrics and Gynecology, Stanford University School of Medicine and the Stanford Cancer Center.

Previous work with IT-101 suggests that protracted "maintenance doses" of IT-101 may minimize the typical chemotherapy side effects, allow for an improved quality of life with continued treatment, and prolong time till disease progression. The company plans to begin dosing patients by the third quarter of this year.

IT-101, a conjugate of camptothecin and Insert's proprietary cyclodextrin polymer nanoparticle, Cyclosert, has demonstrated a highly favorable toxicity profile and pharmacokinetic characteristics. IT-101 is currently in ongoing phase I studies at City of Hope Cancer Center in Duarte, California.