CytRx, a biopharmaceutical research and development company, has announced plans to initiate a Phase II clinical trial for its drug candidate INNO-206 to treat patients who suffer from advanced, treatment-resistant soft tissue sarcomas. Soft tissue sarcomas are cancers that form in the soft tissues of the body, such as muscle, fat, fibrous tissue and blood vessels. The trial will focus on patients for whom surgery and radiation therapy have been ineffective.
The study will enroll 50 patients from medical centers in the U.S., Europe and India. Patients will be given INNO-206 once every three weeks for four consecutive cycles. They will be evaluated for overall tumor response and progression-free survival. CytRx expects to complete enrollment within 12 months.
According to CytRx President and CEO Steven A Kriegsman, patients with advanced soft cell sarcoma have a grim prognosis. The median survival rate is 18 months. Less than a third of these patients live past three years. Even the most effective treatment, a combination of the anti-cancer drugs ifosfamide and doxorubicin, does not significantly increase patient survival.
INNO-206 is a derivative of the chemotherapy drug doxorubicin. It is designed to control drug release and target tumors. In a Phase I clinical trial of 35 patients with various cancers, INNO-206 partially reduced tumors in 3 patients, while the disease stabilized in 20 patients. INNO-206 was also effective in previous animal studies, producing statistically significant results for breast, ovarian, pancreatic and small cell lung cancers.
Los Angeles-based CytRx has a number of other products in its pipeline: Tamibarotene to treat acute promyelocytic leukemia; Iroxanadine, a small molecule drug for the treatment of diabetic ulcers; Arimoclomol for amyotrophic lateral sclerosis; and Bafetinib for chronic myeloid leukemia. The company is also developing two drug candidates to repair or degrade misfolded proteins associated with disease.