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Avantogen and Innovate Oncology Announce Presentation of Clinical Data Demonstrating Extended Survival in Patients with Pancreatic Cancer Treated with RP101.


SYDNEY, Australia & SAN DIEGO & NEW YORK New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 -- Presentation at Prestigious International Conference on Tumor Progression Indicates Median Survival and Time to Progression Both Improve Dramatically with RP101 Cotreatment

Avantogen Limited (ASX ASX

See: Australian Stock Exchange
:ACU ACU

See: Asian currency units
), and Innovate Oncology (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:IOVOE), today said encouraging clinical results from a study of RP101 in patients with pancreatic cancer pancreatic cancer

Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men.
 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.

In 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 cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic.

cis·plat·in
n.
. 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.

In 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 cytostatic /cy·to·stat·ic/ (sit?ah-stat´ik)
1. suppressing the growth and multiplication of cells.

2. an agent that so acts.


cy·to·stat·ic
adj.
1.
 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 pancreatic 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 American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research,
 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 international biotechnology company developing a broad oncology-related product portfolio. Avantogen has acquired the North American North American

named after North America.


North American blastomycosis
see North American blastomycosis.

North American cattle tick
see boophilusannulatus.
 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. Avantogen's Pentrys(TM) anti-cancer vaccine is being evaluated in prostate cancer patients in Phase IIb clinical studies and the company is advancing several immune enhancing adjuvants in three Phase I cancer trials. The immune enhancing adjuvants were developed by Galenica, a privately held U.S. vaccine developer. Avantogen acquired Galenica in July 2004. The company also markets Revisys(TM), a branded line of medical nutritionals designed for people with special needs, including those undergoing cancer treatments. Avantogen is traded on the Australian Stock Exchange Australian Stock Exchange (ASX)

Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987.
 (ASX) under the symbol ACU. The company has established a Level 1 ADR ADR - Astra Digital Radio  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 Frankfurt Stock Exchange

The largest of Germany's eight securities exchanges, operated by Deutsche Borse AS.
, trading under the symbol CBS (Cell Broadcast Service) See cell broadcast. .

About Innovate Oncology

Innovate Oncology Inc., a company founded by Bioaccelerate Holdings Inc., is developing a range of pharmaceuticals focused on areas of need within oncology. Innovate's lead product, currently in Phase II, prevents the development of resistance to commonly used chemotherapeutic agents. In addition, Phase II studies are imminent on another unique molecule that has demonstrated activity in several different tumor types. Innovate is developing a novel form of paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia);  employing technology to facilitate oral bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration.

bi·o·a·vail·a·bil·i·ty
n.
 and a novel nitroacridine derivative with specific activity against prostate cancer. Preclinical projects with significant potential include new methods of inhibiting the RAS (1) See network access server.

(2) (Remote Access Service) A Windows NT/2000 Server feature that allows remote users access to the network from their Windows laptops or desktops via modem. See RRAS and network access server.
 signaling pathway and the Her2/neu oncogene oncogene

Gene that can cause cancer. It is a sequence of DNA that has been altered or mutated from its original form, the proto-oncogene (see mutation). Proto-oncogenes promote the specialization and division of normal cells.
, an antiangiogenic an·ti·an·gi·o·gen·ic
adj.
Inhibiting the growth of blood vessels.


antiangiogenic
 monoclonal antibody and a project to identify a small molecule mimic of a novel prostate tumor suppressor protein. For further information visit www.innovateoncology.com.

About RESprotect

RESprotect GmbH is a privately owned biotechnology company located in Dresden Germany. RESprotect is focusing on the inhibition of chemoresistance and the enhancement of chemosensitivity. In contrast to the well known efforts to circumvent or decrease existing chemoresistance, this basic approach is unrivalled. Chemogenomics the approach of RESprotect, focuses on the application of small synthetic molecules, which elicit favorable phenotypic changes. The combination with genomic tools concentrating on specific biological pathways allows a better understanding of the broader effect of the drug. By doing so, it is possible to discover drugs that target the cause of a disease rather than its symptoms. RESprotect's compounds are given additionally to standard chemotherapy. Chemotherapy relies upon the induction of apoptosis (self inflicted death) of tumor cells, which is the main anti-cancer mechanism. One major problem in chemotherapeutic treatment is the induction of chemoresistance, which antagonizes the apoptosis of cancer cells. The chemogenomics approach of RESprotect resulted in the identification of a number of validated targets contributing to the development of chemoresistance by antagonizing apoptosis. RP101, the Company's first small molecule drug candidate, suppresses the over-expression of apoptosis-antagonizing gene products induced by cytostatic drug treatment.

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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Such forward-looking statements are subject to risks and uncertainties that could cause Avantogen'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.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Sep 20, 2005
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