Avantogen and Innovate Oncology Announce Presentation of Clinical Data Demonstrating Extended Survival in Patients with Pancreatic Cancer Treated with RP101Presentation at Prestigious International Conference on Tumor Progression Indicates Median Survival and Time to Progression Both Improve Dramatically with RP101 Cotreatment SYDNEY, Australia & SAN DIEGO & NEW YORK--(BUSINESS WIRE)--Sep 20, 2005 - Avantogen Limited (ASX:ACU), and Innovate Oncology (OTCBB:IOVOE), today said encouraging clinical results from a study of RP101 in patients with pancreatic cancer were presented at the 2nd International Conference on Tumor Progression and Therapeutic Resistance, currently being held at the Boston Marriott, Burlington MA. The presentation by Professor Rudolf Fahrig, founder of RESprotect GmbH, entitled: "Cotreatment with (E)-5-(2-Bromovinyl)-2-(01) Significantly Enhances Survival in Patients with Pancreatic Cancer," extends the survival results from a previously reported, completed clinical study that evaluated RP101 co-administered with standard chemotherapy. Avantogen and Innovate have jointly licensed RP101 from RESprotect, and intend to sponsor clinical trials of RP101 in the U.S. starting in early 2006. n February 2005, dramatic observations from a clinical trial conducted by RESprotect were released in which thirteen pancreatic cancer patients with stage III and IV disease were treated with RP101, and gemcitabine plus cisplatin. Those results indicated that the 50% probability of survival was increased to an average of 15 months, from a historic average of 7.5 months (p = 0.008) obtained at the same institution under otherwise similar conditions during the prior year. It was also noted that ten of the original thirteen patients lived longer than one year, and six of them were still alive. n the current presentation, Prof. Fahrig updates these results, in which patients were originally treated with gemcitabine, 1000 mg/m(2) IV over 30 minutes plus cisplatin 50 mg/m(2) on Days 1 and 15 of a 28 day schedule. RP101, 500 mg per day, was added to the treatment regimen on the same day, and for four days after chemotherapy. Ten of the thirteen original patients survived at least one year following treatment; median survival was 447 days, which is higher than a historic control from the same institution. Time to Progression was 280 days, also higher than historic control. At present, four of the original thirteen treated patients remain alive for nearly two years. Avoiding resistance to chemotherapy would represent a significant breakthrough in the treatment of pancreatic and other cancers," said Dr. Fahrig. "These results are very encouraging and provide a sound rationale for continued evaluation of RP101 to expand the therapeutic window for chemotherapy and extend survival while improving the quality of life for pancreatic cancer patients." Patients undergoing repeated chemotherapy can develop resistance, enabling cancer cells to continue to grow and spread during treatment. RP101 is intended as co-treatment with cytostatic drugs to prevent the development of resistance to chemotherapy. Avoidance of resistance to chemotherapy would be viewed as a major breakthrough in the treatment of pancreati and other cancers and such therapies as RP101 could be useful in expanding the therapeutic window for chemotherapy, extending survival while improving the quality of life for pancreatic cancer patients. The American Cancer Society estimates that in 2005, over 32,000 new cases of pancreatic cancer will be diagnosed, and an equal number will die of the disease.
About Avantogen Avantogen(formerly Australian Cancer Technology) is an internationalbiotechnology company developing a broad oncology-related productportfolio. Avantogen has acquired the North American marketing rightsfor RP101, a promising pancreatic cancer drug currently in Phase IIclinical studies through a subsidiary company, Resistys Inc, a jointventure with Bioaccelerate of New York. Avantogen's Pentrys(TM)anti-cancer vaccine is being evaluated in prostate cancer patients inPhase IIb clinical studies and the company is advancing several immuneenhancing adjuvants in three Phase I cancer trials. The immuneenhancing adjuvants were developed by Galenica, a privately held U.S.vaccine developer. Avantogen acquired Galenica in July 2004. Thecompany also markets Revisys(TM), a branded line of medicalnutritionals designed for people with special needs, including thoseundergoing cancer treatments. Avantogen is traded on the AustralianStock Exchange (ASX) under the symbol ACU. The company has establisheda Level 1 ADR stock program in the U.S. trading under the symbol AUCJYand also is listed on the Xetra exchange, the electronic trading systemof the Frankfurt Stock Exchange, trading under the symbol CBS. About Innovate Oncology nnovateOncology Inc., a company founded by Bioaccelerate Holdings Inc., isdeveloping a range of pharmaceuticals focused on areas of need withinoncology. Innovate's lead product, currently in Phase II, prevents thedevelopment of resistance to commonl used chemotherapeutic agents. Inaddition, Phase II studies are imminent on another unique molecule thathas demonstrated activity in several different tumor types. Innovate isdeveloping a novel form of paclitaxel employing technology tofacilitate oral bioavailability and a novel nitroacridine derivativewith specific activity against prostate cancer. Preclinical projectswith significant potential include new methods of inhibiting the RASsignaling pathway and the Her2/neu oncogene, an antiangiogenicmonoclonal antibody and a project to identify a small molecule mimic ofa novel prostate tumor suppressor protein. For further informationvisit www.innovateoncology.com. About RESprotect RESprotectGmbH is a privately owned biotechnology company located in DresdenGermany. RESprotect is focusing on the inhibition of chemoresistanceand the enhancement of chemosensitivity. In contrast to the well knownefforts to circumvent or decrease existing chemoresistance, this basicapproach is unrivalled. Chemogenomics the approach of RESprotect,focuses o the application of small synthetic molecules, which elicitfavorable phenotypic changes. The combination with genomic toolsconcentrating on specific biological pathways allows a betterunderstanding of the broader effect of the drug. By doing so, it ispossible to discover drugs that target the cause of a disease ratherthan its symptoms. RESprotect's compounds are given additionally tostandard chemotherapy. Chemotherapy relies upon the induction ofapoptosis (self inflicted death) of tumor cells, which is the mainanti-cancer mechanism. One major problem in chemotherapeutic treatmentis the induction of chemoresistance, which antagonizes the apoptosis ofcancer cells. The chemogenomics approach of RESprotect resulted in theidentification of a number of validated targets contributing to thedevelopment of chemoresistance by antagonizing apoptosis. RP101, theCompany's first small molecule drug candidate, suppresses theover-expression of apoptosis-antagonizing gene products induced bycytostatic drug treatment. Forward-Looking Statements Statements contained in this press release that are not historicalinformation are forward-looking statements as defined within thePrivate Securities Litigation Reform Act of 1995. Such forward-lookingstatements are subject to risks and uncertainties that could causeAvantogen's ("company") actual results to differ materially from thoseprojected or implied. Such potential risks and uncertainties relate,but are not limited, to the results of clinical trials, product demandand market acceptance, the impact of competitive products and pricing,effectiveness and pace of current and future product development, andregulatory approval. More detailed information on these and additionalfactors tha could affect the company's operating and financial resultsare described in the company's annual reports filed or to be filed withthe Australian Stock Exchange. The company urges all interested partiesto read these reports to gain a better understanding of the manybusiness and other risks that the company faces. The historical resultsachieved by the company are not necessarily indicative of its futureprospects. The company undertakes no obligation to publicly update orrevise any forward-looking statements, whether as a result of newinformation, future events or otherwise. ContactAvantogen Dr. Leonard Firestone, 858-458-6807
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Innovate Oncology, Inc. Sujay R. Kango,
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or RESprotect GmbH Prof. Dr. RudolfFahrig, +49 351 4503201
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www.resprotect.de |