Immunicum submits IND application to the Food and Drug Administration (FDA) for approval to treat kidney cancer patients in the United States in its ongoing phase II-trial
Gothenburg, Sweden, July 22, 2016 - Immunicum AB (publ), a biopharmaceutical company pursuing to develop sophisticated, safe and efficient therapeutic cancer treatments with powerful and long lasting immune responses, today announced that the Company has submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) in the U.S. The application is requesting approval to treat kidney cancer patients in the U.S. with Immunicum's lead cancer immune primer, INTUVAX®, in its ongoing MERECA (MEtastatic REnal cell CArcinoma) phase II-trial.
Immunicum's INTUVAX® is a unique cancer immune primer currently being tested in clinical trials for the treatment of kidney cancer and liver cancer as well as GIST (gastrointestinal stromal tumor). As previously reported, results from Immunicum's completed phase I/II-trial for treatment of kidney cancer have been promising.
Today's announcement of the submission of the IND application to the FDA is one more step forward in the Company's clinical plans to expand it's testing of INTUVAX® into the U.S. Approval from the FDA is expected within 30 days.
For further information, please contact:
Jamal El-Mosleh, CEO, Immunicum
Phone: +46 (0) 31 41 50 52 email@example.com
The Company's Certified Adviser is Redeye AB Phone: +46 (0) 8 545 013 31. www.redeye.se
INTUVAX is a cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated white blood cells, so called dendritic cells, derived from healthy blood donors. Intratumoral injection of these cells is expected to lead to an inflammatory response which in turn leads to tumor-specific activation of the patient's cytotoxic T lymphocytes.
About Immunicum AB (publ)
Immunicum AB (publ) is working to develop and advance cancer immune primers for the treatment of tumor diseases. A clinical phase II trial for the Company's most advanced product - INTUVAX® against kidney cancer - has been initiated. The project portfolio contains additional clinical phase I/II studies in liver cancer and in gastrointestinal stromal tumors (GIST).
For more information, please visit www.immunicum.com