Biomira: Phase 2a trial of Cvac in ovarian cancer shows promising results

By E. Janene Geiss

Philadelphia, May 16 - Biomira Inc. said Tuesday that its commercialization partner, Prima BioMed, reported favorable results in its Cvac ongoing phase 2a clinical trial in ovarian cancer.

A second analysis of data made available to Prima BioMed's Scientific Advisory Panel indicated that so far 21% of patients in the trial had achieved either a clinical response to treatment or stabilization of their disease, according to a company news release.

Patients in the overall study are late-stage progressive ovarian cancer patients with no therapeutic alternative.

A benchmark response rate is considered 15% of patients with clinical response or stabilization of disease, and it warrants progression to a comparative clinical trial, officials said.

The primary objective of the trial is to determine whether Cvac, a cancer immunotherapy, can produce clinical responses or stabilization of ovarian cancer, as determined by monitoring the blood marker, CA125, a well recognized tumor marker of disease activity.

Twenty-eight ovarian cancer patients were recruited to the trial, all of whom had previously failed other forms of therapy and were assessed as having progressive disease by increases in CA125 levels.

Twenty-one of these patients went on to complete the required dosing (three injections) of Cvac to qualify for inclusion in the study, officials said.

The Biomira/Prima BioMed agreement was originally negotiated with CancerVac, a wholly owned subsidiary of Prima BioMed, providing that Biomira has the sole option to elect to either license the exclusive worldwide commercialization rights (excluding Asia, Australia and New Zealand) or only the North American region for this product candidate, following conclusion of the phase 2a trial in ovarian cancer, or Biomira has an option to simply license technology to Prima BioMed, officials said.

Such election is to be made by Biomira following Biomira's review of the phase 2a clinical trial data. Biomira said it has a 1.62% equity stake in Prima BioMed.

Biomira said it plans to meet with some clinical experts and the principal investigator on the trial to discuss the results with Prima BioMed management, once all of the data is available.

Depending on the outcome of that review, the company said it would then convene a gynecological advisory board in the summer of 2006 to discuss the potential for moving forward.

Prima BioMed, a Melbourne, Australia, biotechnology company, said it expects to complete the trial in the fourth quarter of 2006.

Biomira is an Edmonton, Ont., biotechnology company specializing in development of cancer therapeutics.

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