ChemGenex Pharmaceuticals’ patent related to the manufacture of its leukemia candidate received approval. The patent covers the semisynthetic production of homoharringtonine (Ceflatonin®) and its analogs and the use of these compounds in a treatment of leukemia. The patent provides ChemGenex and its partner, Stragen Pharma, with a proprietary position until 2019 in the U.S.
Ceflatonin is a potent inducer of apoptosis in myeloid cells and inhibits angiogenesis. In Phase II studies, it demonstrated clinical activity in patients with chronic myeloid leukemia (CML), both as a single agent and in combination with other chemotherapeutic drugs, according to ChemGenex.
The company is developing Ceflatonin for the treatment of CML, and pilot studies are underway in myelodysplastic syndrome (MDS) and in acute myeloid leukemia (AML).
"In addition to the strong regulatory position obtained through patents and orphan drug status in major jurisdictions, the Ceflatonin clinical development program is progressing very well,” points out Greg Collier, Ph.D., CEO and managing director. “We now have 11 centers in the U.S.A. and Europe recruiting patients for our registration-directed trial of Ceflatonin in chronic myeloid leukemia patients with the T315I mutation who have failed Gleevec therapy."