The FDA has placed the IND for NeuVax on a partial clinical hold which precludes RXI from entering into a Phase III clinical trial of NeuVax.
On May 8, 2009, RXI ( 'Apthera' at the time ) submitted an SPA for a Phase III clinical trial for NeuVax. The FDA requires certain CMC information to be submitted prior to the FDA granting its approval to proceed with a Phase III trial. Apthera did not include such CMC information in the SPA application. Although Apthera received notification from the FDA of its acceptance of our SPA in June 2009, in July 2009, the FDA informed Apthera that the IND application had been placed on “partial clinical hold” pending our submission and the FDA’s acceptance of the required CMC information. As a result, while Apthera/RXI is allowed to continue semi-annual treatments of patients enrolled active Phase I/II trials, they are prohibited from initiating a Phase III clinical study until they have completed certain product manufacturing activities, submitted the required CMC information to the FDA and the FDA has approved such information and removed the partial clinical hold from the IND. Such actions will require RXI/Apthera to expend additional funds to meet the FDA’s Phase III requirements, currently estimated by us to be approximately $2.5 million.
With the last two offerings, don't you think RXI has the funds to take this to phase 3. RXI raised over 16 million for a reason. From the Apthera website "Planning is underway for a large, international, pivotal Phase III clinical trial of NeuVax for the treatment of early-stage (node-positive) HER2-positive breast cancer. Apthera intends to obtain regulatory approval of NeuVax for the treatment of breast cancer in both the U.S. and international markets." All this for a 93 cent investment. The risk/reward is too great to pass up. Not to mention RXI-109. (4 billion dollar market)