ChemGenex Reports Successful Personalized Dosing of Quinamed at ASCO.-- Genotypically Optimized Dosing Results in Improved Tolerance and Evidence of Anticancer Activity -- MELBOURNE, Australia & MENLO PARK, Calif. -- ChemGenex Pharmaceuticals (ASX ASX See: Australian Stock Exchange : CXS CXS Coherent X-Ray Scattering , NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CXSP) announced today the presentation of data from its Quinamed([R]) (amonafide dihydrochloride) phase 1/2a dose-escalation study, designed to identify a genotypically optimised dose of Quinamed in heavily pre-treated patients with a variety of solid tumors. The key outcomes from this study were (i) demonstration that dose level could be optimised according to patient genotype, (ii) the drug was well tolerated, with predictable and manageable side effects Side effects Effects of a proposed project on other parts of the firm. , and (iii) there was evidence of anticancer activity in several solid tumor types. Dr. John Kuhn of the University of Texas Health Science Center in San Antonio, TX, along with the investigators at Sarah Cannon Cancer Center, TN and University of Louisville See also
1. ^ [1] 2. ^ [2] URL accessed on June 8 2006 3. , KY discussed the data in an oral presentation at the American Association of Clinical Oncology (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) 43rd Annual Meeting in Chicago, Illinois. "The clinical activity of amonafide against a variety of cancers has long been recognized, but development has been hampered by the unpredictable side effect profile for patients" said Dr Kuhn. "We are excited by the new opportunities that personalized dosing of Quinamed offers for a range of solid tumor patients who have developed resistance to existing therapies." Highlights of the presentation included: * Confirmation that genotyping of patients prior to treatment allows for optimized personalized dosing and improved drug tolerance. * Patients with rapid and intermediate acetylator genotypes (who more rapidly metabolize me·tab·o·lize v. 1. To subject to metabolism. 2. To produce by metabolism. 3. To undergo change by metabolism. metabolize to subject to or be transformed by metabolism. the drug to the acetylated derivative associated with side effects) achieved a maximum tolerated dose (MTD MTD Mounted MTD Maximum Tolerated Dose MTD Memory Technology Device MTD Month To-Date MTD Methadone (drug screening) MTD motion to dismiss (legal) MtD Mountain Dew MTD Memory Technology Driver ) of 320 mg/m2 of Quinamed weekly, whilst patients with slow acetylator genotypes achieved an MTD of 400 mg/m2 of Quinamed weekly (three weeks on treatment followed by one week off treatment, repeated). Using these dosing regimens, 64% of rapid and intermediate acetylators and 77% of slow acetylators showed no dose-limiting drug toxicities or dose-delay/holds during treatment. * In a population of heavily pretreated patients who were refractory to multiple existing therapies and who had advanced tumors, there was evidence of antitumor an·ti·tu·mor also an·ti·tu·mor·al adj. Counteracting or preventing the formation of malignant tumors; anticancer. Adj. 1. activity in a range of tumor types. Three prostate cancers showed a decline in prostate specific antigen PSA (Prostate specific antigen) A tumor marker associated with prostate cancer. Mentioned in: Tumor Markers (PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. ), with one of these achieving a partial response. Two patients with ovarian cancer achieved stable disease accompanied by a decline in the ovarian cancer biomarker CA125. One patient with gastrointestinal stromal tumor gastrointestinal stromal tumor GIST Surgical pathology A nonmucosal GI tumor most common in the stomach Clinical Benign–leiomyoma or malignant–leiomyosarcoma, determined histologically by ↑ mitotic activity and bizarre cells, findings seen in (GIST) demonstrated stable disease which was sustained over 18 monthly cycles of amonafide. Greg Collier, Ph.D., Chief Executive Officer and Managing Director of ChemGenex said that the results were a significant step in the development of personalized medicines. "The data that Dr Kuhn presented today show very clearly that we now understand the effect of genotype on amonafide metabolism, and that we can dose patients to minimize the side effects of therapy. We are encouraged by the signs of anticancer activity across a range of tumor types in patients who had failed multiple prior therapies, and look forward to progressing Quinamed into further development for indications where the clinical need and commercial potential is greatest." Quinamed([R]) is a registered trademark of ChemGenex Pharmaceuticals Limited. About ChemGenex Pharmaceuticals Limited (www.chemgenex.com) ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing therapeutics in the areas of oncology, diabetes and obesity. ChemGenex harnesses the power of genomics for target discovery and validation, and in clinical trials to develop more individualized therapeutic outcomes. ChemGenex's lead compound, Ceflatonin([R]), is currently in phase 2/3 clinical trials for chronic myeloid leukemia (CML 1. CML - A query language. ["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986]. 2. CML - Concurrent ML. ) and Quinamed([R]) is in phase 2 clinical development for prostate, breast and ovarian cancers. The company has a significant portfolio of anti-cancer, diabetes and obesity programs, several of which have been partnered with international pharmaceutical companies. ChemGenex currently trades on the Australian Stock Exchange Australian Stock Exchange (ASX) Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. under the symbol "CXS" and on NASDAQ 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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