Guest guest Posted July 18, 2005 Report Share Posted July 18, 2005 Looks like they will be studying the effects of Ceflatonin against T315I - interesting... ChemGenex Announces Strategy for Registration-Directed Clinical Trials for Ceflatonin® ChemGenex Pharmaceuticals Limited (ASX:CXS) (NASDAQ:CXSP), based in Melbourne, Australia and Menlo Park, Ca, USA, today announced its accelerated clinical development plan for its lead anti-cancer therapeutic, Ceflatonin® (homoharringtonine, HHT). The initiation of the first of two registration-directed Phase 2/3 trials is scheduled for the third quarter of 2005. The first trial will target chronic myeloid leukemia (CML) accelerated phase patients who are resistant to high-dose Gleevec®. The single agent Phase 2/3 trial will initially be conducted in six leading European cancer centers, and is expected to expand to incorporate cancer centers in the U.S. in Q1, 2006. The trial incorporates the benefits of the company's recent in-licensing agreement with Stragen Pharma and builds on growing clinical evidence that Ceflatonin® has significant potential as a treatment for CML patients who are resistant to Gleevec® and other experimental bcr-abl kinase inhibitors. It is anticipated that the enrollment in this trial of up to 85 patients will be completed in Q4, 2006. A second single agent Phase 2/3 clinical trial with Ceflatonin® to treat CML patients with a specific gene mutation that makes them resistant to tyrosine kinase inhibitors such as Gleevec® (the T315I bcr-abl mutation) is planned to commence in the U.S. and Europe in Q1, 2006, and will recruit up to 85 patients. This study will be initiated based on evidence from recent Phase 1/2 studies that HHT has activity in CML patients who have developed bcr-abl point mutations associated with tyrosine kinase inhibitor resistance. ChemGenex has ongoing Phase 2 clinical trials under its U.S. IND at the M.D. Cancer Center in Houston, Texas (Ceflatonin® in combination with Gleevec® in CML and Ceflatonin® as a single agent in myelodysplastic syndrome (MDS)). " This is a major advance in our clinical development of Ceflatonin®, " said Dr. Greg Collier, chief executive officer and managing director of ChemGenex Pharmaceuticals. " The new trial designs offer considerable advantages; we have developed protocols for the sub-cutaneous, rather than intravenous dosing of patients and we have new data demonstrating synergy when used in-combination with Gleevec®. As the number of CML patients developing bcr-abl point mutations associated with resistance to tyrosine kinase inhibitors such as Gleevec® increases, there will be considerable need for treatments such as Ceflatonin® that combat the disease via a different mechanism. " ChemGenex has updated its company overview presentation to include the new clinical strategy for Ceflatonin®. The presentation can be accessed from the company's home page (www.chemgenex.com). About ChemGenex Pharmaceuticals Limited (www.chemgenex.com) ChemGenex Pharmaceuticals is a gene-based pharmaceutical company dedicated to improving the lives of patients by developing therapeutics in the areas of oncology, diabetes, obesity, and depression. ChemGenex currently has two compounds in Phase 2 clinical trials, Ceflatonin® for leukemia and Quinamed® for solid tumors, and has a significant portfolio of anti-cancer, diabetes, obesity and depression programs. The company's diabetes and obesity program is partnered with Merck KGaA and the depression program is partnered with Vernalis plc. ChemGenex currently trades on the Australian Stock Exchange under the symbol " CXS " and the NASDAQ exchange under the symbol " CXSP. " Safe Harbor Statement Certain statements made herein that use the words " estimate, " " project, " " intend, " " expect, " " believe, " and similar expressions are intended to identify forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements of the company to be materially different from those which may be expressed or implied by such statements, including, among others, risks or uncertainties associated with the development of the company's technology, the ability to successfully market products in the clinical pipeline, the ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated technologies, the ability to enter into additional collaborations and strategic alliances and expand current collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development, the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary technology, potential limitations on the company's technology, the market for the company's products, government regulation in Australia and the United States, changes in tax and other laws, changes in competition and the loss of key personnel. These statements are based on our management's current expectations and are subject to a number of uncertainties that could change the results described in the forward-looking statements. Investors should be aware that there are no assurances that results will not differ from those projected. Quote Link to comment Share on other sites More sharing options...
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