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Adventrx says FDA affirmed IND proposal for clinical trials of chemotheraphy agent ANX-530
By E. Janene Geiss
Philadelphia, Dec. 7 - Adventrx Pharmaceuticals, Inc. announced Wednesday that it has conducted a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration regarding the proposed New Drug Application regulatory plan for ANX-530 (vinorelbine emulsion).
The FDA has affirmed the company's proposal to conduct a single bioequivalency study of ANX-530 as a marketing-enabling clinical trial, company officials said in a news release.
ANX-530 is a novel, emulsion formulation of vinorelbine tartrate. Vinorelbine is a chemotherapeutic agent indicated as a single agent or in combination with cisplatin for treatment of advanced non-small cell lung cancer.
"We are quite pleased that the FDA agreed with our clinical approach for ANX-530. Conducting a single marketing-enabling trial gives us the most direct path toward launching ANX-530 as our first commercial product," Evan M. Levine, president and chief executive officer, said in the release.
The company said it plans to file the Investigational New Drug Application in the first half of 2006 and begin the clinical trial in the first half of 2006 with the objective of filing a New Drug Application for marketing approval in 2007.
The proposed clinical trial will compare the bioequivalency of ANX-530 and vinorelbine in patients with advanced solid tumors. The company said it also plans to collect comparative data on vein irritation and other safety parameters as secondary endpoints.
The company said it holds certain exclusive rights to ANX-530 per the licensing agreement with SD Pharmaceuticals, Inc. announced in October.
Adventrx is a San Diego biopharmaceutical research and development company focused on developing new technologies for anticancer and antiviral treatments that improve performance and safety of existing drugs by addressing problems such as drug metabolism, toxicity, bioavailability and resistance.
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