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news.ChemGenex Pharmaceuticals has launched a multi-center phase II study evaluating the use of Ceflatonin in combination with Novartis' Gleevec, in Gleevec-resistant leukemia.
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Gleevec (imatinib mesylate) is a targeted therapeutic with global sales in excess of $1.6 billion in 2004. It was first approved in 2001 for the treatment of advanced-stage chronic myelogenous leukemia (CML) patients, and it remains the dominant therapy for CML globally.
However, despite Gleevec’s effectiveness in early-stage CML, responses in late-phase patients are usually short-lived, with only 15% of patients experiencing a durable response.
Thus, while Gleevec and other investigational tyrosine kinase inhibitors have generated excellent results, there is still a need to improve therapy in CML. Agents with novel mechanisms of action are needed to treat patients who fail or develop resistance to tyrosine kinase inhibitors like Gleevec. Moreover, agents with synergistic mechanisms of action are needed for use in-combination with tyrosine kinase inhibitors to limit resistance and increase the chances of a cure.
Laboratory and human studies have demonstrated that HHT (homoharringtonine, the active ingredient in Ceflatonin) is active in patients with CML who have become resistant to Gleevec.
In a recent phase I safety study sponsored by the National Cancer Institute (NCI) investigators observed no significant toxicities and 50% of the patients responded to HHT therapy. In preclinical studies, HHT showed synergistic activity with Gleevec as measured by a reduction in the marker (Bcr-Abl protein expression) that is a hallmark of Gleevec resistance in CML.
These studies indicate that Ceflatonin shows promise against CML, both as a single agent therapy in advanced stages of the disease and in combination with Gleevec for earlier stage disease.
“Ceflatonin is an attractive agent to combine with Gleevec because it has confirmed phase II single agent activity in refractory CML. We also know that it has a complementary mechanism of action that can reduce Bcr-Abl protein expression associated with Gleevec resistance,” said Dr Greg Collier, CEO and managing director of ChemGenex.
“Our objective in this study is to induce a good patient response while at the same time reducing the Bcr-Abl proteins associated with resistance to Gleevec and CML disease progression.”
ChemGenex shares have risen close to 4% on the Australian Stock Exchange following the news.