CytRx is a biopharmaceutical research and development company specializing in oncology. The company’s oncology drug pipeline includes three programs in clinical development for cancer indications: aldoxorubicin, tamibarotene, and bafetinib.
The company today announced the initiation of a Phase 1b clinical trial to determine the maximum tolerated dose and evaluate the preliminary efficacy of its aldoxorubicin drug (formerly INNO-206) administered in combination with the commonly used chemotherapeutic agent doxorubicin in patients with advanced solid tumors that have failed to be helped by other therapies. Aldoxorubicin is a tumor-targeting conjugate of doxorubicin. Recent animal trials using this drug combination have showed favorable results in ovarian and pancreatic cancers.
The single-center Phase 1b clinical trial will be conducted under the direction of Dr. Sant P. Chawla, director of the Sancoma Oncology Center in Santa Monica, California, and will enroll up to 24 patients. Doxorubicin will be administered at 50% of its maximum tolerated dose in combination with escalating doses of aldoxorubicin to determine the maximum tolerated dose of this drug combination in this patient population.
In June, CytRx reported results for a Phase 1b/2 clinical trial indicating that aldoxorubicin administered at its maximum tolerated dose showed clinical benefit in 10 of 13 patients with relapsed or refractory soft tissue sarcoma (cancer). Based on these positive results, CytRx plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 trial as a therapy for patients afflicted with soft tissue sarcoma whose tumors have progressed, even following chemotherapy treatment.
For additional information about CytRx, aldoxorubicin, and its entire drug pipeline, please visit the company’s website at www.cytrx.com
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