Immunicum announces that the Company has received approval to start a phase I/II study in patients with gastrointestinal stromal tumor
Gothenburg, Sweden, 2015-12-16 08:30 CET (GLOBE NEWSWIRE) --
Immunicum AB (publ) announces that it has received clearance from the Medical Products Agency and the Ethics Committee to start its fourth clinical study with the cancer immune primer INTUVAX. The study will be conducted on 12 patients with gastrointestinal stromal tumor (GIST) at the Karolinska University Hospital in Stockholm.
"The first observations of INTUVAX® in humans looks promising and have made our research group wanting to look more closely at INTUVAX's effect on critically ill GIST patients. As far as we know, there are only very few studies looking at how a cancer immune primer can improve the prognosis for this patient population", said principal investigator, MD and Associate Professor Robert Bränström, Division of Endocrine and Sarcomas Surgery, Karolinska University Hospital.
The study is expected to start in the beginning of 2016 and will be conducted at the Karolinska University Hospital during about a year. This is the fourth clinical study with INTUVAX®. The Company's most advanced clinical trial is an ongoing phase II study in patients with metastatic renal cell cancer (mRCC). Immunicum also has an ongoing phase I/II study in patients with primary liver cancer and a completed phase I/II study in mRCC where the Company continues to follow overall survival.
"We are very proud that the Karolinska University Hospital wants to start this collaboration with Immunicum. The study's focus goes well together with our hypothesis that INTUVAX can act in synergy with different add-on treatments that can dampen immunosuppression in different types of cancer. The Karolinska University Hospital gives us the opportunity to quickly and cost-effectively determine the effect of INTUVAX since, this time, our primary measure of efficacy is tumor response. If the study delivers positive data, we will seek orphan drug designation for INTUVAX for the treatment of GIST", says Immunicum's CEO, Jamal El-Mosleh.
Up to 12 patients with GIST, showing signs of progression with established second-line treatment with sunitinib (Sutent®, Pfizer) will be included in the study. The study design gives Immunicum the opportunity to compare the effect of two and three vaccine doses (for the first six respectively the last six patients in the study). Since Immunicum's completed phase I/II study in patients with metastatic renal cell carcinoma, including patients with so-called sarcomatoid tumor development, showed signs of synergy between INTUVAX and sunitinib, the GIST patients who progress despite ongoing treatment with sunitinib will remain on sunitinib treatment during at least three months.
The study's primary objective is to determine safety and the most important secondary objective is to study whether patients showing progression and resistance to existing treatment after INTUVAX treatment show objective tumor response.
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).