FDA clears a path for TroVax trials, partnership

The FDA has given Oxford BioMedica a clear path to test its late-stage therapeutic vaccine TroVax for a variety of cancers, and the company has enthusiastically responded with plans to advance ongoing partnering discussions on the program.

TroVax ran into serious trouble last year when the therapeutic vaccine failed a Phase III trial for renal cancer. Regulators, though, told the UK developer that "confounding factors" may have played a role in hiking the number of deaths reported in the trial. And the agency "accepted that there was no evidence of specific adverse events that could attribute the imbalance of deaths to TroVax." The FDA's position on the program "has provided a clear path for further development of TroVax in multiple cancer settings."

"The TRIST study has yielded valuable insights into the potential for TroVax as a therapeutic cancer vaccine, despite not achieving its primary endpoint," said CEO John Dawson. "We are delighted by the outcome of the FDA's review, which enables us to advance our discussions with prospective partners and the oncology community. We have already received expressions of interest from several pharmaceutical companies that have previously reviewed the program. We remain committed to the successful development and commercialization of TroVax and we are now in a position to widen our partnering initiative such that we maximize the value of this key asset."

- check out the release
- read the report from Reuters

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