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Australian Cancer Technology Provides Update on Ongoing Clinical Study of Pentrys Vaccine for Prostate Cancer

Posted on: Friday, 18 February 2005, 00:00 CST

Australian Cancer Technology (AustCancer) (ASX:ACU) today provided an update with respect to the ongoing clinical study of its Pentrys(TM) anti-idiotypic vaccine in patients with refractory prostate cancer.

The multi-center open label Phase IIb study is being conducted by Cancer Trials Australia, a consortium of four Melbourne Hospitals and three Research Institutes. Of these, the three consortium members participating in the study include Melbourne's Austin Health, Royal Melbourne Hospital and the Peter MacCallum Cancer Center.

To date, 36 of the 40 anticipated participants in the study have been enrolled and dosed. The study is designed to confirm the safety profile of Pentrys and evaluate the clinical efficacy as measured by the delay of disease progression in this patient population.

"Patient enrollment is almost complete, although admittedly, recruitment has been slower than expected," said Paul Hopper, chief executive officer of AustCancer. "Because only 22 of the 36 enrolled patients have reached the 17 week mark, an important benchmark in the study, the data remain immature and therefore a meaningful analysis is not yet possible. That said, we are on track to complete enrollment by the end of March and with the current dosing regimen should expect to complete the study toward the end of the year. We remain confident that Pentrys will become an integral component of the prostate cancer treatment armamentarium." Hopper noted that the company will announce the full study results once the trial has been completed and the data evaluated.

About Pentrys(TM)

AustCancer's Pentrys(TM) vaccine technology is based on the first synthesis of human monoclonal antibodies to the mutated p53 tumor suppressor gene protein product. It is an anti-idiotypic vaccine whereby the patient receives molecular mimics of the mutated p53 protein (peptides) to stimulate an immune response. The patient subsequently produces antibodies to the target p53 protein expressed on the cancer cells; the p53 target is seen as foreign and a destroying response is initiated.

The p53 gene produces the p53 protein that is essential in regulating the division of cells. Normal p53 protein prevents cells with damaged DNA from multiplying. However, in approximately 50% of all cancers, including breast, bowel, prostate and lung, the gene for p53 is mutated, thus inhibiting the original function and resulting in uncontrolled cell division and growth. In these cells, fragments of the mutated p53 protein are over-expressed on the cancer cell surface creating a differentiating element between normal and cancerous cells and providing a target for immune response.

A Phase Ib/IIa clinical trial using the Pentrys(TM) vaccine was successfully completed at St. Vincent's Hospital, Sydney, Australia in 2002 and demonstrated an immune response in all 14 patients enrolled with a variety of metastatic cancers. The vaccine was well tolerated by all subjects and no major adverse events occurred.

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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