CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that it has initiated an open-label Phase 1b safety and dose escalation clinical trial with INNO-206 at the Sarcoma Oncology Center in Santa Monica, California. The clinical trial will include up to 24 patients with advanced solid tumors who have failed standard therapies.
“Determining the maximum dose of INNO-206 in patients with solid tumors is a major step forward in advancing this oncology drug candidate's development”
INNO-206 is a tumor-targeting pro-drug of the commonly prescribed chemotherapeutic doxorubicin, and was designed to improve efficacy and reduce adverse events through controlled release and preferential targeting of tumors. Doxorubicin is currently the only FDA-approved drug on the market for soft tissue sarcoma, and is a standard chemotherapeutic treatment for a variety of other cancers. Objective clinical responses have been seen with INNO-206 in patients with sarcoma, breast and lung cancers in an earlier Phase 1 trial.
"Determining the maximum dose of INNO-206 in patients with solid tumors is a major step forward in advancing this oncology drug candidate's development," said CytRx President and CEO Steven A. Kriegsman. "We have already completed drug formulation and manufacturing optimization in anticipation of moving rapidly into Phase 2 clinical programs following completion of this clinical trial.
"We are delighted to be working with the well-respected Sarcoma Oncology Center. We expect that a number of patients enrolled in the clinical trial will have advanced soft tissue sarcoma, which could yield significant information, especially as this is the first of several indications for planned Phase 2 clinical testing with INNO-206," he added.
Chief Medical Officer Daniel Levitt, MD, Ph.D., said, "This clinical trial will allow us to evaluate the safety of administering doses of INNO-206 that are over 2 to 4 times the standard dose of doxorubicin, which we believe we can accomplish without an increase in observed side effects over those historically seen with doxorubicin. We are encouraged by the fact that INNO-206 has demonstrated significantly greater efficacy than doxorubicin in animal models of breast cancer, small cell lung cancer, renal cancer, pancreatic cancer and ovarian cancer."