Avantogen Oncology Inc. Files IND Application for RP101.LOS ANGELES -- Avantogen Oncology, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :AVTO) today announced that it has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration for RP101, a compound being investigated for the treatment of 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. . The company plans to start a Phase 2, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double blind, placebo-controlled study to assess RP101 therapy combined with gemcitabine chemotherapy versus gemcitabine chemotherapy alone in patients with metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. pancreatic cancer. The study is based on state-of-the-art design considerations, with survival at 6 months from randomization randomization (ranˈ·d  ·m as the primary efficacy endpoint. Tumor response rate and progression-free survival will be evaluated as secondary endpoints, along with safety and tolerability. "We are very pleased that we have reached this significant milestone in the clinical development program of RP101, which we believe could become a meaningful therapeutic for patients with pancreatic cancer," said Chris Nowers, Chief Executive Officer of Avantogen Oncology. Standard chemotherapy typically offers patients with advanced pancreatic cancer a median survival of approximately 6 months. In contrast, two open label, multi-center, Phase 1 trials indicated that RP101 in combination with standard chemotherapy was associated with a median survival of approximately 14 months and 9 months, when compared to well matched historical control patients receiving standard chemotherapy alone. The Phase 2 study is targeted to start early in 2007. About Avantogen Oncology, Inc. Avantogen Oncology is an international biotechnology company developing a focused oncology product portfolio, including the clinical evaluation clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy of RP101, for patients with advanced pancreatic cancer and the pre-clinical evaluation of two further candidates, capridine beta in the setting of prostate cancer and an oral formulation 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); . Avantogen Oncology, Inc. is traded on the OTC Bulletin Board OTC Bulletin Board An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. under the symbol AVTO. For further information, visit www.avantogenoncology.com or contact; Chris Nowers, Chief Executive Officer, Avantogen Oncology, Inc. 2121 Avenue of the Stars, Suite 2550, Los Angeles, CA 90067, USA Tel: +1 310 279 2932 Email: cnowers@avantogenoncology.com Forward-Looking Statements Statements contained in this press release that are not historical information are forward-looking within the meaning of the safe harbor provisions of 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 may cause the company's actual results to differ materially from stated expectations. Such potential risks and uncertainties include, among others, the results of clinical trials, access to capital, the effectiveness and pace of current and future product development efforts, regulatory approvals, product demand and market acceptance, the impact of competitive products and other factors which may be identified from time to time in the company's SEC filings and other public announcements. |
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