Positive PhIII PONV study brings little Acacia to a crossroads

Acacia Pharma says it gleaned positive results from a Phase III study of its experimental therapy designed to prevent postoperative nausea and vomiting (PONV). And now it's brought in the investment banker J.P. Morgan Cazenove to advise the board on what its next steps should be as it tries to position the treatment for regulatory approval and commercialization.

Acacia CEO Julian Gilbert

In the study, the Cambridge, U.K.-based biotech says it tracked a 19.4% risk reduction in PONV, a sharp plunge from the results seen in earlier, and much smaller, studies sponsored by Acacia. CEO Julian Gilbert, though, says he wasn't surprised by the drop, which reflects similar fluctuations in related late-stage trials.

There are already a couple of different remedies available for these patients, he adds, but high-risk patients in danger of failing those treatments are in need of a third option--which is where Acacia sees an opportunity. And rather than shoot for a quick regulatory OK, with its primary focus on the U.S. market, Gilbert wants to pursue some additional trial work ahead of a filing in order to get some information in the label that will help position the drug.

"We will be doing a study looking at the efficacy of our drug in combination with current anti-emetics, and one or two looking at our drug as a rescue treatment following failure of a prophylactic," says Gilbert, who counts himself as quite pleased by the fact that Acacia got through Phase III on its own while pushing a pipeline with 4 programs.

But first, the company--which has a lean-and-mean virtual staff of three full-timers and several part-time workers--has to make some decisions on funding.

"We don't have the money to take those programs through to the market," says the CEO, "but we do have supportive investors. We have started working with strategic advisers on which route we want to go down."

Just about everything is on the table right now, he adds. They could sell the company, perhaps file an IPO, raise more cash or execute a licensing pact.

- here's the release

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