SD Pharmaceuticals Inc. (SD Pharma) has granted Adventrx Pharmaceuticals Inc. an exclusive license of certain rights to ANX-530, a novel emulsion formulation of vinorelbine tartrate.
In preclinical testing, ANX-530 demonstrated markedly reduced vein irritation following repeated IV injections compared with Navelbine, GlaxoSmithKline's US FDA approved form of vinorelbine.
Severe phlebitis is a known complication of standard vinorelbine therapy. Vinorelbine is currently used as a monotherapy or in combination with other chemotherapeutic agents for the treatment of non-small-cell lung, breast, ovarian and other cancers. It works by disrupting microtubule formation and is a member of the class of antineoplastic drugs known as vinca alkaloids, agents that inhibit cellular replication and ultimately cause cellular death.
Adventrx currently plans to pursue a 505(b)(2) regulatory path for ANX-530 and has initiated discussions with the FDA for the clinical trial design. The company is preparing for its pre-investigational new drug (IND) meeting with the FDA scheduled for December this year, states a company release.
The license agreement between Adventrx and SD Pharma grants Adventrx exclusive US rights to ANX-530 and all future intellectual property related to vinca alkaloid formulations, including compositions for delivering highly water-soluble drugs such as vinca alkaloids and methods of using such compositions.