ChemGenex publishes two new clinical studies supporting Ceflatonin beyond CML to other leukemias

08-29-2006

ChemGenex Pharmaceuticals Limited (CXS and CXSP) announced the recent publication of two clinical research papers that support the expansion of the clinical development of Ceflatonin to include treatment of both newly diagnosed acute myeloid leukemia (AML) patients and those with advanced disease resistant to other therapies.

Dr Jean-Pierre Marie of the Universite Pierre et Marie Curie in Paris published a study in the British Journal of Cancer. The phase 1 study recruited 18 advanced stage acute AML patients who had previously failed other AML treatments, and found that Ceflatonin (homoharringtonine or HHT) had significant clinical benefits. Eleven of 12 patients with circulating leukemic cells showed significant improvement, two achieved complete remission and one chronic myelomonocytic leukemia (CMML) patient in the latter stages of the disease (blast crisis) returned to chronic phase. Myelosuppression was the most common complication, occurring in all patients.

A study by Dr. W-L Wu of the Zhejiang University in China was published in the journal Leukemia. The phase 2 study of 48 patients concluded that homoharringtonine (Ceflatonin) has potential as a first-line therapy in combination with two other agents in young adult patients with AML. Homoharringtonine in combination with cytarabine and aclarubicin resulted in complete remission in 83% of patients, with acceptable levels of toxicity.

Greg Collier, ChemGenex chief executive officer and managing director, said, "These results reported by Drs. Marie and Wu and their internationally regarded clinical teams confirm the activity of homoharringtonine (Ceflatonin) in AML patients. They moreover indicate that Ceflatonin has significant potential across a range of AML states, both for patients who have failed prior therapies and for patients who are commencing treatment for the first time. While the immediate focus of our development activities with Ceflatonin is chronic myeloid leukemia (CML) patients with the T315I mutation, we have ongoing and planned clinical programs in AML and myelodysplastic syndrome (MDS).

"Globally, there is significant unmet medical need across the range of leukemias and we believe that Ceflatonin has the potential to help meet these needs for many patients."

Publication Details

A phase 1 dose-finding and pharmacokinetic study of subcutaneous semisynthetic homoharringtonine (ssHHT) in patients with advanced acute myeloid leukaemia. V Levy, S Zohar, C Bardin, A Vekhoff, D Chaoui, B Rio, O Legrand, S Sentenac, P Rousselot, E Raffoux, F Chast, S Chevret & J P Marie. British Journal of Cancer, Advanced Online Publication. Published online July 18, 2006.

Homoharringtonine in combination with cytarabine and aclarubicin resulted in high complete remission rate after the first induction therapy in patients with de novo acute myeloid leukemia. Jin J, Jiang DZ, Mai WY, Meng HT, Qian WB, Tong HY, Huang J, Mao LP, Tong Y, Wang L, Chen ZM, Xu WL. Leukemia, Advanced Online Publication. Published online June 22, 2006.

This article was prepared by Clinical Oncology Week editors from staff and other reports. Copyright 2006, Clinical Oncology Week via NewsRx.com.