SYDNEY, Australia & SAN DIEGO--(BUSINESS WIRE)--March 17, 2005--Australian Cancer Technology (AustCancer) (ASX:ACU - News; OTCBB:ACUJY - News) today announced that full recruitment has been achieved in the company's 40-patient Phase IIb clinical trial of its Pentrys(TM) idiotypic anti-p53 peptide vaccine in patients with hormone-refractory prostate cancer.
The multi-centre open label Phase IIb study is being conducted by Cancer Trials Australia at three institutions, including Melbourne's Austin Health, Royal Melbourne Hospital and the Peter MacCallum Cancer Centre. The study is designed to confirm the safety profile of Pentrys(TM) and to evaluate its clinical efficacy by measuring serum PSA responses. Once all the patients have completed their participation in the trial, assays will be performed on blood samples to detect antibodies against p53, antibodies against Pentrys(TM), and T cell responses against p53. This is an open label trial without placebo, and the trial Lead Principal Investigator has recommended that assays be carried out at the completion of the trial later this year.
All patients who receive dosing with Pentrys(TM) are required per protocol to attend an End of Study Visit. This visit is scheduled for 3 months after the final Pentrys injection for the patient. Therefore "the date of last patient last study visit" is scheduled to occur mid December 2005, but may occur earlier depending on the number of doses of Pentrys(TM) the patient receives. The study database will be locked 8 weeks after the last patient attends their last study visit. The statistical analysis report will be prepared within 8 weeks of the database lock date.
Dr. Leonard Firestone, the company's newly-appointed CEO, said; "This is an important milestone in our Pentrys(TM) development program. Our group of 40 patients in this clinical trial is now complete. In the coming months physicians will be confirming the safety of the vaccine and its effectiveness in stimulating the immune system, a critical step in delaying the progress of prostate cancer. Our goal is to provide a treatment, which will improve the quality of life for these patients."
About Pentrys(TM)
AustCancer's Pentrys(TM) vaccine technology is based on peptides derived from antibodies to the p53 tumour suppressor gene protein product. It is an "anti-idiotypic" vaccine whereby the patient receives molecular mimics (peptides) of antibodies to the p53 protein. If vaccination is successful, vaccinated patients should produce antibodies and/or T cells that recognize the target p53 protein expressed on the cancer cells. The p53 target is seen by the immune system as foreign and these cells are destroyed.
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, expression of the gene for p53 is abnormal, thus inhibiting the original function and resulting in uncontrolled cell division and growth. In these cells, fragments of the p53 protein are over-expressed on the cancer cell surface, enabling normal and cancerous cells to be differentiated by the immune system and providing a target for immune response.
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. <<
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