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AustCancer Commences Phase II Clinical Study of RP101 for Metastatic Pancreatic Cancer

Posted on: Tuesday, 14 December 2004, 09:00 CST

Australian Cancer Technology ("AustCancer") (ASX:ACU) today 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 Klinikum rechts der Isar, and University of Munich Hospital's Klinikum Grosshadern. 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 U.S." 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 totaling 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 antitumor 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 U.S. biotechnology firm.

About Pancreatic Cancer

The American Cancer Society predicts that, in 2004, about 31,860 people in the U.S. 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.

Additional Ongoing Clinical Studies - Pentrys(TM) for Prostate Cancer

AustCancer also is conducting an open-label, Phase IIb clinical trial of Pentrys(TM), 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.

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

Australian Cancer Technology (AustCancer) is an international biotechnology company developing a broad oncology-related product portfolio. The company's Pentrys(TM) anti-cancer vaccine is being evaluated in prostate cancer patients in Phase IIb clinical studies and RP101, a promising pancreatic cancer drug for which the company has acquired the North American marketing rights, currently is in Phase II clinical studies. AustCancer recently acquired Galenica Pharmaceuticals (renamed Adjuvantys(TM)), and is advancing immune enhancing adjuvants in three Phase I and II cancer trials. The company also markets a line of medical nutritionals under the brand name revisys(TM) that are 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 has undertaken a secondary listing on the Xetra exchange, the electronic trading system of the Frankfurt Stock Exchange, trading under the symbol "CBS."

Source: Business Wire

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