ARQULE REPORTS MONOTHERAPY DATA FOR ARQ 501

ArQule has reported results from a Phase I monotherapy trial with its lead product, ARQ 501, which provided evidence of clinical tolerability and promising antitumor activity in cancer patients with advanced solid tumors who had failed prior treatments with chemotherapy.

In the trial, ARQ 501 was administered to 64 patients with late-stage cancer who had received prior regimens of chemotherapy. Doses ranged from 10 milligrams per meter squared to 660 mg per meter squared. Tumor regression or prolonged disease stabilization was observed in a broad spectrum of cancer types, including pancreatic cancer, head and neck cancer, ovarian cancer, colorectal cancer and leiomyosarcoma.

Evidence of anti-tumor activity was observed in 18 out of 38 patients evaluable for efficacy. Of these 18 patients, evidence of tumor regression was observed in five patients, two of whom had partial responses and three of whom had minor responses (tumor regression by more than 15 percent but less than 30 percent per RECIST).