The company has initiated its phase IIb clinical trial for CVac in the US, under the auspices of the FDA, and intends to start recruitment of patients shortly. In December, the FDA had approved human clinical trial for CVac in phase IIb.
Technology transfer of the manufacturing from Australian base at the Peter Macallum Cancer Centre in Melbourne to the US manufacturer has been completed, and also the design and research of immunological and potency assay for the CVac product. The phase IIb trial will enroll 60 patient population across multiple centres in the US and Australia, and is being conducted at Fred Hutchinson Cancer Centre in Seattle, Stanford University in California, and New York Downtown Hospital.
The trial's objective is to further confirm the ability of CVac to reduce the instance of relapse in ovarian cancer patients, control the metastases of the cancer and increase patients' life expectancy. The results will seek to add to the positive efficacy data from CVac's previous clinical trials, in this case in a larger patient population.
Prima has plans to conduct a phase III clinical trial for CVac in Europe later this year. The phase IIb and phase III trials will run concurrently and deliver results from a larger total patient population over a shorter timeframe - with the overall goal being to fast-track regulatory approval for the ultimate commercialisation of CVac.