ChemGenex teams with MolecularMD to identify CML patients with T315I drug resistance mutation

07-26-2006

ChemGenex Pharmaceuticals (CXS; CXSP) announced an alliance with MolecularMD, Inc., a leading provider of molecular diagnostic services, including drug resistance mutation screening for chronic myeloid leukemia (CML) patients.

The two companies will work together to identify CML patients with the T315I bcr-abl mutation who may be candidates for participation in ChemGenex's phase 2/3 study of Ceflatonin, in CML patients with this mutation.

The T315I point mutation is attracting significant attention globally as T315I expressing cells are resistant to the tyrosine kinase inhibitor imatinib (Gleevec), and CML patients who develop this mutation no longer respond to Gleevec. In addition, preliminary data suggest that CML patients with the T315I point mutation also fail to respond to treatment with either of two second generation tyrosine kinase inhibitors currently in clinical development.

"We are delighted to partner with MolecularMD, whose scientific cofounder, Brian Druker, MD, is recognized worldwide for his key contributions to the development of imatinib for the treatment of CML," said Greg Collier, PhD, chief executive officer and managing director of ChemGenex. "CML patients typically develop genetic mutations as their disease progresses, requiring accurate and reliable molecular diagnosis to determine if alternative therapies or a combination of drugs might be needed, as well as to fully assess the efficacy of their treatment."

Druker added that, "We are pleased that ChemGenex is offering a treatment option for patients with the T315I mutation and look forward to assisting in identifying candidates for this study."

Collier noted that Ceflatonin shows in vitro activity in CML cell lines with the T315I mutation and has already demonstrated clinical activity in human clinical studies for patients failing Gleevec. Demonstration of positive results in CML patients with the T315I mutation who have failed Gleevec therapy could potentially serve as the basis for filing a New Drug Application with the U.S. Food and Drug Administration under an accelerated approval, based on a high level of unmet medical need.

Gleevec is a registered trade-mark of Novartis AG.

ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing therapeutics in the areas of oncology, diabetes, obesity, and depression. ChemGenex harnesses the power of genomics for target discovery and validation, and in clinical trials to develop more individualized therapeutic outcomes.

MolecularMD is a privately owned molecular diagnostics company based in Portland, Oregon. The company offers state-of-the-art measurement of expression and mutation analysis for genes that have been identified as relevant targets for various types of cancers. Pharmaceutical companies performing clinical trials and oncologists employ the company's test to diagnose and monitor the fundamental molecular signals related to their patient's disease.

This article was prepared by Cancer Gene Therapy Week editors from staff and other reports. Copyright 2006, Cancer Gene Therapy Week via NewsRx.com.