FDA Wants Another Phase III Trial for BiovaxID Therapeutic Vaccine

Biovest, makers of the therapeutic lymphoma vaccine BiovaxID®, had a formal clinical guidance meeting with US drug regulators at the FDA yesterday.

The purpose of the meeting was to map out the fastest and most thorough path towards seeing BiovaxID reach US markets.

According to a press release, important aspects of the meeting included:

Biovest outlining the unmet need of as many as half of all follicular lymphoma patients who achieve first remission following induction therapy but then receive no more treatment despite the overwhelming odds that they will relapse. Additional treatment consolidation agents are needed for this patient population, they argued.

Unfortunately, what they get are immunosuppressive agents like rituximab that target the protein CD20 on the cell surface—the same target of their induction therapy.

Immunosuppressive drugs leave patients at risk

When rituximab is administered in a consolidative, maintenance setting, it is typically administered six times per year for a number of years. The immunosupressed patient is therefore put at prolonged risk of increased susceptibility to infection

The meeting also featured a setback for Biovest. The FDA is requiring Biovest to conduct a confirmatory Phase III clinical trial, meant to support the findings from the Phase III BiovaxID trial BV301. Typically confirmatory trials like this are called phase 4 trials; it's unclear why the FDA is asking for another phase III trial.

The good news from the meeting is that Biovest will be working directly with the FDA to develop the registration trial design for the study and that meeting is expected to take place in the coming months.

In the meantime, Biovest will continue to its activities in Canada and the European Union to get BiovaxID approval in those markets and available to patients who could benefit from it.

Source: Biovest