Immunicum has received approval to extend the phase I/II-study in liver cancer by up to six patients to be treated with INTUVAX in combination with first-line treatments
Gothenburg, Sweden, 2015-12-16 08:57 CET (GLOBE NEWSWIRE) --
Immunicum AB (publ) announced today that the Swedish Medical Products Agency and the Ethics Committee has approved that the phase I/II-study in liver cancer may be extended by up to six patients who will receive INTUVAX in combination with first-line treatments.
In October 2013, Immunicum started a phase I/II-study (IM-102) in liver cancer. Patients who previously failed on first-line treatments started treatment with the cancer immune primer INTUVAX.
An update of the safety and survival data for the ongoing phase I/II trial (IM-102) with INTUVAX for patients with primary liver cancer (NCT01974661) on November 25 2015 showed that no serious side effects had been related to the vaccine. Ten patients with the diagnosis primary hepatocellular carcinoma (HCC) had been treated. Seven patients had received their three scheduled INTUVAX doses. Two of the patients suffered a very rapid progression of the disease already before treatment could start and passed away before the second and third doses could be given. One patient had received the first of three planned treatment doses and one patient was expected to start treatment before the year-end.
All patients had demonstrated tumor progression (tumor growth) after conventional first-line treatment (local chemoembolization or systemic treatment with Nexavar) before start of INTUVAX-treatment.
It could be noted that out of the seven patients who received all three planned INTUVAX doses, five patients exhibited a survival that exceeded the expected median overall survival. Two of the fully treated patients were still alive and one of these had not yet passed the expected median overall survival.
Immunicum now announces that it has received approval to extend the phase I/II-study by inclusion of up to six additional patients who will receive INTUVAX as first-line treatment in combination with local chemoembolization of the tumor or with the tyrosine kinase inhibitor Nexavar.
- The good safety profile that INTUVAX has demonstrated in liver cancer now makes it possible for us to target a patient population that can get INTUVAX at an earlier stage of the disease, in this case as first-line treatment in combination with either local chemoembolization or with the tyrosine kinase inhibitor Nexavar. Thus, the study gives us the opportunity to investigate the potential synergistic effect of INTUVAX in combination with local chemoembolization or with systemic treatment with Nexavar. Regarding combination with local chemoembolization, we expect a synergistic effect with INTUVAX since local chemoembolization is expected to increased the amount of dying tumor cells which can subsequently be taken up by locally recruited dendritic cells. The expected synergy with Nexavar is based on Nexavar's proven ability to reduce the immunosuppression inherent in tumors, says Immunicum's Chief Scientific Officer, professor Alex Karlsson-Parra.
- By including up to six new patients under the frames of the current study, we save time and money compared to starting a new safety study on INTUVAX in combination with first-line therapy in primary liver cancer. The new setup will give us important information for a possible future phase II/III trial in that indication, says Immunicum's CEO Jamal El-Mosleh.
For further information, please contact:
Jamal El-Mosleh, CEO, Immunicum
Phone: +46 (0) 31 41 50 52
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) develops 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 an additional clinical phase I/II study in liver cancer and an upcoming clinical phase I/II study in gastrointestinal stromal tumors (GIST).