Avantogen Oncology Inc. Announces FDA Acceptance Of Its IND For The Novel Cancer Drug Candidate, RP101.LOS ANGELES Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850. -- Avantogen Oncology, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :AVTO) today announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug Application (IND) 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. . As a result of the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. decision 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 assessing RP101 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 will proceed. The previously announced study will have survival at 6 months as the primary efficacy endpoint, while tumor response rate and progression-free survival will be evaluated as secondary endpoints, along with safety. Patient accrual is currently targeted to begin early in 2007. "This important IND approval enables us to move RP101 to the next stage of clinical development and progress its assessment as 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 (Fahrig et al., Anti-Cancer Drugs 17,1045-56, 2006). About Avantogen Oncology, Inc. Avantogen Oncology is an international biotechnology company that is developing a focused oncology product portfolio. The priority clinical program is the evaluation of RP101 in conjunction with gemcitabine chemotherapy for patients with pancreatic cancer. Avantogen Oncology, Inc. has its headquarters in Los Angeles, and is publicly 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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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