FDA issues with CRO-run trial in Argentina set back Adventrx

10-Aug-2011 - Last updated on 11-Aug-2011 at 09:09 GMT

Adventrx faces having to redo its pivotal bioequivalence study after the FDA raised concerns about its CRO-managed trial in Argentina.

The US Food and Drug Administration (FDA) has questioned results from the trial as it says it is unable to verify the authenticity of drugs used in the study, which an Argentinean contract research organisation (CRO) ran.

Speaking in an investor conference call after the news Brain Culley, CEO of Adventrx, said he was “disappointed and surprised” at the FDA’s decision. “We believe the authenticity of the drug products used in the pivotal study is verifiable and plan to discuss FDA's concerns in this regard”, Culley said.

The problem, as Culley sees it, stems from the sites destroying samples of products used in clinical trials after they passed their expiration date in March 2008. “Clearly mistakes had occurred”, Culley said, but in his opinion the data is valid despite the problems.

Adventrx and its CRO audited the clinical trial sites, in Buenos Aires, Mendoza, Rosario, Santa Fe and Tucuman, and, with the exception of sample destruction, Culley is pleased with the study. The FDA visited the sites in June and that is when Adventrx first became aware of the agency’s concerns.

Even without samples Culley believes it is clear the trial proceeded correctly. Outsourcing meant Adventrx never handled trial materials and the two products being compared look different, making accidental substitution unlikely. “It would be like confusing skimmed milk and water”, Culley said.

Adventrx hopes to make these points in a meeting with the FDA in the coming weeks. If the FDA still wants Adventrx to redo the trial, it will try to sell on the molecule. Although redoing the trial would be cheap, by the time the study ends Culley expects to be focused on more lucrative compounds.

CMC questions

The FDA also requested information about product quality. “We’re not quite what to make of some of the product quality questions”, Culley said. In 2010 the FDA rejected the marketing application for Exelbine, called ANX-530 then, because of insufficient stability testing data.

The problem began when Adventrx switched to a new contract manufacturing organisation (CMO) in 2008 in anticipation of commercialisation. Chemistry, manufacturing and controls (CMC) data in the filing was from drugs produced by the first CMO, prompting the FDA to reject the application.

Now issues around CMC have again been raised by the FDA. Culley said all the CMC questions asked by the FDA in its latest response have been answered by Adventrx earlier in the review cycle.

“It’s not the first time a company has been somewhat confused by the FDA’s response”. Culley said.

Shares in Adventrx closed down 58 per cent.