Denmark-based biotechnology firm Bavarian Nordic has dosed first patient in a randomised, prospective Phase II trial of its active immunotherapy product candidate CV-301 for treatment of bladder cancer.

In the trial, which is sponsored by the National Cancer Institute, 54 patients with high grade non-muscle invasive bladder cancer whose cancer has progressed after initial BCG (Bacillus Calmette-Guerin) treatment will be given BCG alone, or in combination with CV-301.

The company said that BCG has been approved in many countries to prevent recurrence of superficial bladder tumours.

The trial’s primary endpoint is to determine if there is an improvement in disease-free survival for patients receiving BCG treatment and CV-301 immunotherapy compared with those receiving BCG treatment alone.

“These results suggest that CVT-301 could have a transformative impact on patients’ lives.”

It is assumed that the combined administration of BCG and CV-301 might augment the BCG-induced cytotoxic T lymphocyte response against bladder cancer cells expressing MUC-1 and CEA and potentially reverse BCG failure in patients that progressed following a prior induction course of the therapy.

National Cancer Institute head of Bladder Cancer Section Piyush Agarwal is trial’s lead investigator.

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Bavarian Nordic president of cancer immunotherapy division James Breitmeyer said: “We are hopeful that combination therapy with CV-301 will yield positive results for bladder cancer patients who currently face limited treatment options.”

CV-301 is indicated for treatment of multiple cancers and it originates from the same poxvirus technology platform as PROSTVAC.

The company said that both PROSTVAC and CV-301 are prime-boost vaccines sequentially combining two different poxviruses (vaccinia and fowlpox).

These two product candidates, along with earlier generations of these vaccines, have been the subject of more than 30 clinical trials with approximately 1,100 patients treated for prostate, breast, lung, colorectal, gastric, pancreatic, ovarian and other cancers.

An abstract on the trial, entitled ‘A Randomized, Prospective, Phase II Study to Determine the Efficacy of Bacillus Calmette-Guerin (BCG) given in combination with PANVAC versus BCG given alone in adults with high-grade non-muscle invasive bladder cancer (NMIBC) who failed at least 1 Induction Course of BCG’, has been accepted for presentation in the trials in progress section at the 2014 ASCO Annual Meeting in Chicago, IL from 30 May to 3 June.

Bavarian Nordic is focused in developing and manufacturing new cancer immunotherapies and vaccines for infectious diseases.