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Australian Cancer Technology Reports Doubling of Mean Survival Time in Patients With Pancreatic Cancer Using RP101 With Chemotherapy Treatment

Posted on: Tuesday, 8 February 2005, 18:00 CST

Australian Cancer Technology (AustCancer) (ASX:ACU) today announced results from an extended clinical study evaluating RP101 with chemotherapy demonstrating a doubling of survival in patients with pancreatic cancer.

In an extended Phase I/II clinical study conducted by ResProtect in Germany, 13 patients with metastasized pancreatic cancer were treated with RP101 and gemcitabine plus cisplatin. Of the patients treated, nine had stage IV disease and four had stage III disease. Per treatment cycle, patients were given 125mg of RP101 four times per day for the first five days of treatment. The treatment was repeated ten days later. The regimen was repeated for up to six treatment cycles (1-6). For the treatment group, the 50% probability of survival was increased to an average of 15 months from an historic average of 7.5 months (p=0.008). The historical control was developed using a separate study of 15 patients with stage IV disease and 7 with stage III treated with gemcitabine and cisplatin (Heinemann et al., ASCO 2003, University Munchen). 10 out of the 13 patients lived or live longer than one year, and six of them are still alive. Additionally, time to tumor progression was increased to 7.5 months versus 4.75 months as seen in the Heinemann control group.

According to The American Cancer Society, about 1 out of 4 patients with cancer of the exocrine pancreas will live at least one year after the cancer is found. In the RP101 study, ten out of thirteen patients lived longer than one year. The group predicts that, in 2005, about 32,180 people in the U.S. will be diagnosed with pancreatic cancer and about 31,800 will die of the disease.

"We were very encouraged to note that patient survival was indeed significantly extended in this very ill patient population," said Paul Hopper, chief executive officer of AustCancer. "We believe these data provide a very strong rationale for additional rigorous clinical evaluation of RP101. A dose finding study currently is ongoing in 22 patients in Germany. Later this year, the company intends to initiate additional clinical studies in the U.S. for registration with the U.S. Food and Drug Administration."

Patients undergoing repeated chemotherapy treatment can build a resistance to the chemotherapy's intended toxic effects and cancer cells continue to grow and spread during treatment. RP101 is intended as a co-treatment with cytostatic drugs to prevent the development of chemotherapy resistance, often noted as a significant challenge for oncologists. The company believes that RP101 can be useful in expanding the therapeutic window for chemotherapy, possibly extending survival while also improving the quality of life for pancreatic cancer patients.

In preclinical studies, co-treatment of chemotherapy with RP101 prevented the decrease of apoptotic effects during the course of chemotherapy and reduced non-specific toxicity. In several different in vivo tumor models, the antitumor efficacy of chemotherapy was optimized, and toxic side effects were reduced.

In pancreas carcinoma cells, the oncogene STAT3 is over-expressed leading to the suppression of apoptotic (programmed cell death) responses. Additionally, treatment with gemcitabine leads to the over-expression of the DNA-repair gene APEX, commonly implicated in chemoresistance. RP101 has been shown to down-regulate STAT3 and APEX, in different tumor cell lines.

AustCancer and Bioaccelerate acquired the North American rights to RP101 from RESprotect GmbH in September 2004.

About Australian Cancer Technology (www.austcancer.com.au)

Australian Cancer Technology (AustCancer) is an international biotechnology company developing a broad oncology-related product portfolio. Austcancer has acquired the North American marketing rights for RP101, a promising pancreatic cancer drug currently in Phase II clinical studies through a subsidiary company, Resistys Inc, a joint venture with Bioaccelerate of New York. AustCancer's Pentrys(TM) anti-cancer vaccine is being evaluated in prostate cancer patients in Phase IIb clinical studies and the company is advancing immune enhancing adjuvants in three Phase I cancer trials. The company also markets revisys(TM), a branded line of medical nutritionals designed for people with special needs, including those undergoing cancer treatments. AustCancer is traded on the Australian Stock Exchange (ASX) under the symbol ACU. The company has established a Level 1 ADR stock program in the U.S. trading under the symbol AUCJY and also is listed on the Xetra exchange, the electronic trading system of the Frankfurt Stock Exchange, trading under the symbol CBS.

Forward-Looking Statements

Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that could cause Australian Cancer Technology's ("company") actual results to differ materially from those projected or implied. Such potential risks and uncertainties relate, but are not limited, to the results of clinical trials, product demand and market acceptance, the impact of competitive products and pricing, effectiveness and pace of current and future product development, and regulatory approval. More detailed information on these and additional factors that could affect the company's operating and financial results are described in the company's annual reports filed or to be filed with the Australian Stock Exchange. The company urges all interested parties to read these reports to gain a better understanding of the many business and other risks that the company faces. The historical results achieved by the company are not necessarily indicative of its future prospects. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Business Wire

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