The phase I portion of this multi-center study will determine the dosage, safety and tolerability of talotrexin in refractory leukemia patients, including both myeloid and lymphoid leukemias. The phase II component will evaluate the success of the drug in relapsed or refractory acute lymphoblastic leukemia.
At present there is no treatment provided for adults with acute lymphoblastic leukemia, a form of cancer in which immature white blood cells are attacked. Patients with the disease are open to infection as the number of fully formed blood cells they possess is severely depleted.
“This trial represents an important milestone for accelerating the clinical development of talotrexin,” said Greg Berk, chief medical officer and vice-president of Hana. “Antifolates have recognized activity in lymphoid malignancies but have been limited by emerging drug resistance. We believe talotrexin may be less susceptible to these mechanisms of resistance.”
Talotrexin is also being assessed in patients with advanced solid tumors and non-small cell lung cancer, with a further trial planned in cervical cancer. The National Cancer Institute’s Gynecologic Oncology Group will be collaborating in this research.