Wednesday, 18 February, 2015
Immunicum AB (publ) today announced that the Swedish Medical Products Agency has granted the Company’s application to commence a phase II clinical trial in patients with renal cell carcinoma with the therapeutic cancer vaccine INTUVAX in Sweden. In addition to an approval from the Ethics Committee to start the trial in Sweden, Immunicum will also need clearance from a number of other European regulatory authorities to start enrollment of patients in more countries during spring 2015.
INTUVAX is a therapeutic cancer vaccine being developed to treat solid tumors such as kidney cancer and liver cancer. The upcoming phase II trial has been designed based on the promising results obtained in a phase I/II trial in patients with metastatic renal cell carcinoma. A follow-up of this study shows that the median survival in a subgroup of five high-risk patients is over 22 months, which compares with an expected median survival of nine months, with current standard treatments.