CytRx to initiate a multinational Phase 2 clinical trial of its doxorubicin prodrug

Nov 24 2009

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced plans to initiate a multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a treatment for patients with advanced soft tissue sarcomas who have failed surgery and radiation. Soft tissue sarcomas are cancers that are formed in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body.

In the open-label Phase 2 clinical trial, 50 patients will receive INNO-206 once every three weeks for four consecutive cycles. The study will be conducted in approximately 25 study centers in the U.S., Europe and India. Following trial initiation, patient enrollment is expected to be completed in approximately 12 months. These patients will be evaluated on an ongoing basis for overall tumor response and progression-free survival.

“Our decision to move into Phase 2 clinical testing in advanced soft tissue sarcomas was largely based on positive clinical and preclinical trial results with INNO-206,” said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. “In animal testing, INNO-206 was safely administered at higher levels than doxorubicin, demonstrating superior antitumor efficacy of this widely used chemotherapeutic agent. Phase I trial results showed that INNO-206 was safe when administered at six times the standard dosing of doxorubicin and produced objective clinical responses in patients with sarcoma, breast and lung cancers.”

CytRx President and CEO Steven A. Kriegsman said, “Patients with advanced soft tissue sarcomas who can no longer be treated with surgery have a poor prognosis. Progression-free survival for this group is around six to seven months, and median overall survival is approximately 18 months with less than one-third of these patients living past three years. Combinations of the chemotherapy drugs ifosfamide and doxorubicin appear to offer the highest response rates and longest time to progression in these patients; however, these regimens have not significantly improved survival. The ability to administer INNO-206 at a higher dose than doxorubicin without potentially increasing side effects could enhance these patients’ quality of life and potentially prolong survival.”

Source CytRx Corporation