Phase III trial with ANX-188 in patients with sickle cell disease will begin by year end.

Patheon negotiated a contract with Adventrx covering formulation, fill, and finish of the latter’s lead candidate ANX-188 (purified poloxamer 188) for clinical trials, including a Phase III study projected to start this year against sickle cell disease. Adventrx deal with Patheon follows on from an agreement signed earlier this month with Pierre Fabre, for manufacture of the ANX-188 active ingredient.

ANX-188 is an aqueous solution of a purified form of poloxamer 188, a nonionic, block copolymer agent that has been shown to improve microvascular blood flow by reducing viscosity, and has potential applications in a range of disorders including complications arising from sickle cell disease. Adventrx says decades of research has demonstrated that P188 binds to hydrophobic surfaces that develop when cells are damaged and restores normal hydrated surfaces, but has little or no activity in normal, healthy tissues. Research has in addition demonstrated that P188 prevents adhesion and aggregation of soluble fibrin in the blood and maintains the deformability of red blood cells, the nonadhesiveness of unactivated platelets and granulocytes, and the normal viscosity of blood, the firm claims.

Nonpurified and purified formulations of P188 have previously been studied in a range of clinical trials as a potential treatment in acute myocardial infarction, sickle cell disease, and malaria. In contrast to previous formulations, however, Adventrx’ purified P188 has been designed to eliminate certain low molecular weight substances present in nonpurified P188, which it believes have been primarily responsible for elevations in serum creatinine levels observed in prior clinical studies of nonpurified P188.

Although the firm is initially developing ANX-188 for the treatment of sickle cell disease-associated complications, it aims to develop ANX-188 for other indications in house, and/or through collaborations. Adventrx is separately developing two formulations of anticancer drugs. Exelbine (ANX-530) is an emulsion formulation of vinorelbine that the firm claims results in a lower incidence of injection site reactions. ANX-514 is a detergent-free emulsion formulation of docetaxel, which is in development to negate the current need for pretreating patients with corticosteroids in order to avoid the toxic effects of the detergents currently used to solubilize docetaxel. 

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