With Orphan Drug status and a largely-unmet medical need for its primary indication, ADVENTRX Pharmaceuticals (AMEX:ANX) expects its lead candidate, ANX-188, to be the company’s most important asset in the next few years. CEO Brian Culley believes the development-stage drug has the potential to reach a large segment of the Sickle Cell population in the U.S., driven by improved clinical development and proprietary manufacturing methods.
In an exclusive interview with PropThink, Culley discusses the mechanism of action for this novel drug, which had been in development for a number of years before ADVENTRX acquired it, but never moved beyond clinical trials. Culley says that the drug hasn’t yet demonstrated its full capabilities, and an upcoming Phase III trial at ADVENTRX, expected to initiate by year’s-end, will improve on older testing strategies. Discussing the development history of ANX-188, he says, “It was very interesting to us to see that in a study that was underpowered and really not optimally designed, they still very nearly reached the threshold of success which is needed for FDA approval.” With better financial backing and advanced manufacturing methods, Culley believes ANX-188 will move to the market with a strong IP portfolio to protect it. The only FDA approved drug for treating Sickle Cell Anemia, hydroxyurea, is sold by Bristol-Myers Squibb (NYSE:BMY) as Hydrea and Droxia.
The discussion touches on the company’s other pipeline products and ADVENTRX’s financial position. Culley also discusses expanding indications for ANX-188, and explains how recent hires at the company bring valuable clinical and regulatory expertise to this development-stage biotech.