Firm has two regulatory-stage emulsion formulations of currently marketed chemotherapy drugs.
Adventrx Pharmaceuticals received gross proceeds of approximately $22.5 million through a registered direct offering. The money will be used to acquire products, to develop its lead candidates, and for general corporate purposes.
Adventrx is developing emulsion formulations of currently marketed chemotherapy drugs. On January 6, FDA accepted the firm’s NDA for Exelbine, a vinorelbine injectable emulsion. On December 15, 2010, Adventrx requested a meeting with the agency to review the study of its second candidate, ANX-514, which is a docetaxel lyophilized emulsion for injection. The marketed reference product for Exelbine is Navelbine® and Taxotere® (sanofi-aventis), respectively.
Navelbine is approved in the U.S. to treat advanced non-small-cell lung cancer (NSCLC) as a single agent or in combination with cisplatin and in the EU to treat NSCLC and advanced or metastatic breast cancer. Generic equivalents of Navelbine have been available in the U.S. since February 2003.
Navelbine and its generic equivalents are associated with injection-site reactions including phlebitis, erythema, and pain at the site of injection, according to Adventrx. 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.
Exelbine is designed to reduce the incidence and severity of these injection site reactions, the firm points out. The formulation emulsifies vinorelbine into a homogeneous suspension of nanoparticles that is designed to protect the venous endothelium during administration into a peripheral vein.
Taxotere is approved to treat breast, non-small-cell lung, prostate, gastric, and head and neck cancers. In the U.S., aspects of Taxotere are covered by patents through November 2013.
According to Taxotere’s label, patients should be observed closely for hypersensitivity or allergic reactions, which may occur within a few minutes following initiation of Taxotere administration. These reactions generally are believed to be associated with polysorbate 80, which is present in Taxotere, and range from mild to severe and, in rare cases, fatal anaphylaxis, Adventrx adds. ANX-514 is formulated without polysorbate 80 or other detergents and is designed to reduce the incidence and severity of side effects associated with detergents such as hypersensitivity reactions, the firm notes.
Adventrx sold 8,184,556 units for $2.75 each, and each unit consisted of one share of common stock, a Series A warrant, and a Series B warrant. The Series A warrants are exercisable for up to an aggregate of 2,046,139 shares of common stock. The Series A warrants have an exercise price of $2.75 per share and are exercisable at any time after the closing of the transaction and before the date that is five trading days after the one-year anniversary of the initial exercise date.
The Series B warrants are exercisable for up to an aggregate of 2,046,139 shares of common stock. They have an exercise price of $2.75 per share and are exercisable at any time after the closing of the transaction and before the five-year anniversary of the initial exercise date.