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ChemGenex to Initiate Phase II Study With Quinamed in Prostate Cancer; Anti-Cancer Activity Observed in Recently Completed Phase I Study

Posted on: Monday, 1 November 2004, 09:00 CST

ChemGenex Pharmaceuticals Limited (ASX:CXS) today announced plans to initiate a Phase II clinical study of Quinamed(R) (amonafide dihydrochloride). The company also provided an update on patients who responded in the recently completed Phase I study. The Phase II study will treat hormone refractory prostate cancer patients who have failed docetaxel.

While the recently completed 32 patient Phase I study was not designed to evaluate efficacy, meaningful responses to Quinamed therapy were observed in patients with prostate cancer, ovarian cancer, colon cancer, and gastrointestinal stromal tumors (GIST). One prostate cancer patient had a reduction in tumor size and PSA count. Two patients with advanced ovarian cancer achieved stabilized disease and were treated with multiple cycles of therapy. Finally, one patient with GIST achieved stabilized disease for over 13 months and continues to do well on Quinamed therapy.

The Phase II study will use the dosing regimen developed in Phase I, which is based on a genomic test for drug metabolism that uses genotyping to determine an individualized dose. The genotypic test correlates with how rapidly a patient will metabolize Quinamed. Genotyping avoids the variability of results observed with phenotyping (categorizing patients based on observable, physical traits), which can be influenced by diet and other factors. ChemGenex believes that precisely determining the appropriate dose for individual patients, based on an assessment of their metabolic status at the genomic level, can maximize antitumor response while minimizing toxicity.

Patients will be genotyped when entering the study and then dosed once weekly for three weeks each month at 400-500 mg/m(2), if they are slow metabolizers, and at 320 mg/m(2), if they are fast or intermediate metabolizers. The study will enroll up to 30 patients and will be conducted at The Sarah Cannon Cancer Center and Tennessee Oncology. Investigators will evaluate the efficacy of Quinamed based on measures including tumor response and PSA counts.

"We are very pleased to advance Quinamed into Phase II development," said Dennis Brown, Ph.D., president of ChemGenex Pharmaceuticals. "While this study will focus on prostate cancer, an indication with high unmet need, the anticancer activity observed in our Phase I investigations suggest that opportunities also exist in other solid tumor types, including ovarian, colon and GIST."

ChemGenex Chief Executive Officer Greg Collier, Ph.D., says that the commencement of the Phase II study is a further step in the development of the company. "The start of the Phase II trial for Quinamed consolidates the company's position in cancer therapeutics. Our cancer therapeutics pipeline is progressing well with two compounds in clinical trials, some exciting pre-clinical leads and several novel targets that have recently been discovered and protected by patent applications. Prostate cancer is a significant market, with more than 220,000 new cases diagnosed and approximately 29,000 deaths per year in the USA."

About ChemGenex Pharmaceuticals Limited (www.chemgenex.com)

ChemGenex Pharmaceuticals is a gene-based pharmaceutical development company dedicated to improving the lives of patients by developing therapeutics in the areas of oncology, diabetes, obesity, and depression. The company was formed in 2004 from the merger of AGT Biosciences of Melbourne, Australia and privately held ChemGenex Therapeutics, Inc. of Menlo Park, California. ChemGenex Pharmaceuticals currently has two compounds in Phase II clinical development, Ceflatonin(R) for leukemia and Quinamed(R) for solid tumors and has a significant portfolio of anti-cancer compounds, diabetes and obesity targets and depression and anxiety targets. The company's diabetes and obesity program is partnered with Merck KGaA and the depression and anxiety program is partnered with Vernalis. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS."

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.

Source: Business Wire

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