Healthcare Industry News: metastatic pancreatic cancer
News Release - October 30, 2006
Avantogen Oncology Inc. Announces FDA Acceptance Of Its IND For The Novel Cancer Drug Candidate, RP101LOS ANGELES--(HSMN NewsFeed)--Avantogen Oncology, Inc. (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.
As a result of the FDA decision a Phase 2, randomized, double blind, placebo-controlled study assessing RP101 combined with gemcitabine chemotherapy, versus gemcitabine chemotherapy alone, in patients with metastatic 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 under the symbol AVTO.
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 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.
Source: Avantogen Oncology
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