Exelbine™ is a novel emulsion formulation of the chemotherapy drug vinorelbine. Navelbine®, a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer.

Background and Potential Benefits

Navelbine and its generic equivalents are vesicants and often associated with injection site reactions, including phlebitis, erythema and pain at the site of injection. As reported in the Navelbine label, injection site reactions occurred in approximately one-third of 365 patients treated in three clinical studies with Navelbine as a single agent, with 5% of these reactions categorized as severe.

Exelbine was designed to be a bioequivalent formulation of Navelbine that may reduce the incidence and severity of injection site reactions to Navelbine. Our formulation emulsifies vinorelbine into a homogeneous suspension of nanoparticles that is designed to reduce the interaction between vinorelbine and the venous endothelium during administration into a peripheral vein, thereby reducing irritation associated with administration of the drug.

Development Status

The Company has elected to discontinue independent development of Exelbine and is seeking a partner or outside investor to complete the necessary bioequivalence study.