Gothenburg, Sweden, 2015-05-05 09:01 CEST (GLOBE NEWSWIRE) -- Immunicum AB (publ) today announced that the first patient has been included in the international phase II study with the therapeutic cancer vaccine INTUVAX for the treatment of patients with metastatic kidney cancer.
INTUVAX is a therapeutic cancer vaccine, based on blood components from healthy donors, that has been developed for treating patients with solid tumors. The phase II study, MERECA (MEtastatic REnal cell CArcinoma), has been designed on the basis of the promising results obtained in a phase I/II trial in patients with metastatic renal cell cancer.
Immunicum plans to include a total of 90 patients at 20 European centers. INTUVAX is injected in the primary tumors at two occasions before a surgical removal of the kidney with the primary tumor. Patients will be randomized (randomly distributed) 2:1 between either INTUVAX in combination with sunitinib or only sunitinib, an approved drug for the treatment of kidney cancer.
The study will include 60 % patients with intermediate-risk prognosis and 40 % patients with high-risk prognosis. Patients will be monitored for 18 months with the primary objective to evaluate the median overall survival in high-risk prognosis patients. Patients in the treatment arm with a high-risk prognosis receive INTUVAX and will subsequently receive add-on treatment with sunitinib beginning six weeks after surgery, while patients in the treatment arm with intermediate-risk prognosis receive INTUVAX as monotherapy with subsequent add-on therapy with sunitinib only when/if the disease shows signs of progression.
- The open design of the MERECA study gives us continuous valuable information about the efficacy and safety of INTUVAX. It facilitates planning of future studies and increases the scope for a possible earlier out-licensing of the project. Of course, the market will also continuously be updated on efficacy and safety data when information is deemed relevant, says Immunicum’s CEO Jamal El-Mosleh.
For further information, please contact:
Jamal El-Mosleh, CEO, Immunicum
Phone: +46 (0) 31 41 50 52
jamal.el-mosleh@immunicum.com
Alex Karlsson-Parra, CSO, Immunicum
Phone: +46 (0) 705 16 75 79
alex.karlsson-parra@immunicum.com
The company’s Certified Adviser is Redeye AB
Phone: +46 (0) 8 545 013 31. www.redeye.se
About Immunicum AB (publ)
Immunicum AB (publ) develops vaccines for the treatment of tumor diseases. A phase II study of the Company's most advanced project - INTUVAX® against renal cancer – has been initiated. The project portfolio contains an additional clinical phase I/II project in liver cancer.
www.immunicum.com