ADVENTRX Pharmaceuticals (ANX) announced early Tuesday that the FDA has accepted its Investigational New Drug [IND] application for a bioequivalence study of its cancer drug candidate ANX-530.
The study will aim to compare ANX-530, a generic anti-cancer drug, to Navelbine, already approved for small cell cancers. The new study is to be initiated in 2007, and the company expects to file a New Drug Application [NDA] by the end of 2007.
Preclinical studies of ANX-530 have shown the following conclusions:
- Pharmacokinetics were unchanged between ANX-530 and Navelbine
- No difference in anti-tumor activity was found between the two formulations
- ANX-530 showed less irritation of the vein and site of injection
Shares of ADVENTRX were trading at $2.75 a share, up more than 4% in pre-market action.
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