SAN DIEGO, Feb. 7 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX), announced today that complete pharmacokinetic data from the Company's marketing-enabling bioequivalence clinical study of ANX-530 (vinorelbine emulsion) has been accepted for presentation at the 2008 American Association for Cancer Research (AACR) Annual Meeting, which takes place April 12 - 16, 2008 in San Diego, CA.
The poster presentation entitled "Pharmacokinetic equivalence observed between an emulsion formulation of vinorelbine (ANX-530) and vinorelbine solution in a clinical study of patients with advanced cancer," is scheduled to be presented on April 13, 2008.
ADVENTRX recently completed a marketing-enabling bioequivalence clinical study of ANX-530. The primary endpoint in the study was met, with pharmacokinetic equivalence observed between ANX-530 and the reference drug Navelbine(R). Furthermore, ANX-530 demonstrated a statistically significant reduction in injection site reactions when compared to Navelbine. Presentation of complete safety results including injection site reactions, have been submitted for presentation at an upcoming oncology conference. ADVENTRX intends to submit to the U.S. Food and Drug Administration (FDA) a Section 505(b)(2) New Drug Application (NDA) for ANX-530 in the fourth quarter of 2008.
About ANX-530 (vinorelbine emulsion)
ANX-530 is designed to reduce the incidence and severity of injection
site reactions from intravenous delivery of vinorelbine tartrate.
Vinorelbine tartrate 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
|SOURCE ADVENTRX Pharmaceuticals, Inc.|
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