AustCancer commences metastatic pancreatic cancer study.

Australian Cancer Technology (Sydney, Australia), said it has initiated a Phase II clinical study of RP101 for the treatment of metastatic pancreatic cancer.

The eight-month study, which will include 22 patients with metastatic pancreatic cancer, will be conducted at three leading centers in Germany: Chemnitz Clinics in collaboration with the Technical University Dresden; Munich University of Technology's Kilinikum rechts der Isar; and, University of Munich Hospital's Klinikum Gro[sz]hadern. RP101 tablets are administered in conjunction with conventional chemotherapy agents and will be evaluated in this study with Gemcitabine. The first patient has been enrolled and dosed. The trial is being managed by the leading Swiss CRO, Hesperion.

Our previous two Phase I pilot studies in pancreatic carcinoma combining RP101 with chemotherapy have been promising, demonstrating good safety and strong patient responses that encourage us to move forward in the development of RP101 for pancreatic cancer patients," said Paul Hopper, Managing Director of AustCancer. "RP101 is intended as a co-treatment with cytostatic drugs to overcome the induction of chemoresistance, thereby expanding the therapeutic window and possibly extending survival while also improving the quality of life for pancreatic cancer patients. Following the successful completion of this study, we intend to commence a pivotal Phase IIb/III trial in the United States" Hopper noted that the company would seek Orphan Drug Status for the compound.

RP101 is a well known anti-viral drug currently marketed in some European countries including Germany for herpes zoster. Especially in pancreas carcinoma cells, the oncogene STAT3 is over-expressed, leading to the suppression of apoptotic responses. In addition, treatment with chemotherapy leads to over-expression of the DNA-repair gene APEX and, in turn, chemoresistance. One of the main effects of RP101 is the down-regulation of STAT3 and APEX thereby enabling the chemotherapy to have its desired effect.

In two previous pilot studies totalling 39 patients, treatment with RP101 demonstrated a reduction of side effects, rather than an increase in side effects, and strong improvement of responses over and above chemotherapy alone. 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 tumor models, the anti-tumor efficacy of chemotherapy was optimized, and toxic side effects were reduced.

AustCancer expects to release survival data from the previous pilot studies in January/February 2005.

AustCancer acquired the North American license to RP101 from RESprotect GmbH in August 2004 and is jointly developing RP101 with Bioaccelerate, a United States biotechnology firm.

The American Cancer Society predicts that, in 2004, about 31,860 people in the United States will be diagnosed with pancreatic cancer and about 31,270 will die of the disease. Pancreatic cancer is the fourth leading cause of cancer death in men and women. About 1 out of 4 patients with pancreatic cancer will live at least one year after the cancer is detected, and only about 1 in 25 will survive for five years or more. For metastasized pancreatic cancer, patients are not expected to survive more than two years.

AustCancer also is conducting an open label, Phase IIb clinical trial of Pentrys, an anti-idiotypic cancer vaccine for prostate cancer. The first of 40 prostate cancer patients in the study was vaccinated in April 2004 and the study is being conducted at three centers in Australia, including Austin Hospital, Peter MacCallum Cancer institute and Royal Melbourne Hospital. AustCancer expects to report interim data from this study the end of January/February 2005.

Australian Cancer Technology

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www.austcancer.com.au