ADVENTRX Cleared To Initiate Vinorelbine Emulsion Bioequivalence Study

Main Category: Lung Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 29 Dec 2006 - 0:00 PDT

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ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that its Investigational New Drug (IND) application for the clinical development of its proprietary cancer drug ANX-530 (vinorelbine emulsion) has been accepted by the United States Food and Drug Administration (FDA). In taking this action, the FDA acknowledged the suitability of the Company's clinical study protocol to establish the bioequivalence of ANX-530, and Navelbine(R) (vinorelbine tartrate). Navelbine is an anti-cancer agent approved for use in non-small cell lung cancer.

Patient recruitment for this study is expected to begin in January 2007. The FDA has affirmed this 28-patient clinical study to be sufficient as a marketing-enabling trial.

"We believe ANX-530 will show bioequivalence to the marketed form of vinorelbine," said Evan M. Levine, chief executive officer of ADVENTRX. "Further, we anticipate filing a new drug application (NDA) by the end of 2007, potentially making ANX-530 the Company's first commercial oncology product."

This bioequivalence study builds on promising preclinical results which demonstrated that the pharmacokinetics of ANX-530 were unchanged as compared to the approved form of vinorelbine. Furthermore, no difference in anti-tumor activity was observed between the two formulations. In addition, ANX-530 demonstrated markedly reduced vein irritation, edema, and erythema at the site of injection.

The study is a multicenter, open-label, randomized crossover comparison of ANX-530 and the approved reference product Navelbine(R) (vinorelbine tartrate) in 28 patients with advanced solid tumors. The primary objective of the study is to evaluate the pharmacokinetic profile of the two drugs in serum.

About Section 505(b)(2)

The Company plans to file an NDA for ANX-530 based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.

About ANX-530 (vinorelbine emulsion)

ANX-530 is a novel emulsion formulation of vinorelbine tartrate, a generic chemotherapy agent. ANX-530 is designed to reduce the incidence and severity of vein irritation from IV-delivery of the drug. Vinorelbine works by disrupting microtubule formation and is a member of the vinca alkaloid class of antineoplastic agents. Vinorelbine is indicated as a single agent or in combination with cisplatin for treatment of advanced non-small cell lung cancer and has also shown activity in breast, ovarian, and other cancers.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing low development risk pharmaceuticals for cancer and infectious disease that enhance the efficacy and/or safety of existing therapies. More information can be found on ADVENTRX's web site at http://www.adventrx.com.

Forward Looking Statement

ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors that, if they do not materialize or prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such forward-looking statements are made based on management's current expectations and beliefs and should not be regarded as a statement or representation by ADVENTRX that any of its plans, including its anticipated milestones, will be achieved on time or at all. The potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to: the risk that ADVENTRX will be unable to raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and milestones; the potential to attract a strategic partner and the terms of any related transaction; the ability to timely enroll subjects in ADVENTRX's current and anticipated clinical trials; the results of pending clinical trials for ANX-530 or ADVENTRX's other product candidates, including the lack of bioequivalence of ANX-530 and Navelbine; the potential for ANX-530 and ADVENTRX's other product candidates to receive regulatory approval for one or more indications on a timely basis or at all, and the uncertain process of seeking regulatory approval; other difficulties or delays in developing, testing, manufacturing and marketing of and obtaining regulatory approval for ANX-530 or ADVENTRX's other product candidates; the market potential for vinca alkaloids and other target markets, and ADVENTRX's ability to compete in those markets; unexpected adverse side effects or inadequate therapeutic efficacy of ANX-530 or ADVENTRX's other products that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; the risk that preclinical and clinical results are not indicative of the success of subsequent clinical trials and that products will not perform as preclinical and clinical data suggests or as otherwise anticipated; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; the scope and validity of patent protection for ANX-530 and ADVENTRX's other product candidates; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at http://www.sec.gov.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. All forward-looking statements are qualified in their entirety by this cautionary statement and ADVENTRX assumes no obligation to revise or update any forward-looking statement, including as set forth in this press release, to reflect events or circumstances arising after the date on which it was made.

ADVENTRX Pharmaceuticals
http://www.adventrx.com

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