Patients received repeated infusions of Rexin-G intravenous over a period up to nine months. Analysis of safety and efficacy data showed no major toxicity, while documenting significant control of tumor growth, the company said.
Analysis of efficacy in 42 patients with bone and soft tissue sarcoma showed a dose-response relationship between overall survival and Rexin-G which was highly significant.
A confirmatory Phase II study in 17 osteosarcoma patients showed a median overall survival greater than seven months; that is, after failing standard chemotherapies. Two patients are disease-free greater than six months after surgical resection of residual tumors and Rexin-G given as both neoadjuvant and adjuvant monotherapy.
These studies indicate that intravenous Rexin-G is safe and well-tolerated, and Rexin-G controls tumor growth and improves survival in a dose-dependent manner in patients with chemotherapy-resistant metastatic soft tissue sarcoma and osteosarcoma.