Immunicum submits the final report for its phase I/II trial in metastatic renal cell carcinoma showing positive safety data and promising survival data
Göteborg, Sweden, 2014-03-31 08:56 CEST (GLOBE NEWSWIRE) -- Immunicum® AB (publ) today submitted the final report to the Swedish Medical Products Agency regarding its clinical phase I/II study in 12 patients with newly diagnosed kidney cancer, treated with the cancer vaccine INTUVAX®. No vaccine-related serious adverse events were noted and the report presents a hitherto achieved median survival for patients with poor prognosis that clearly exceeds the expected median survival for patients treated with established drugs that are often associated with serious side effects. Data also shows clear signs of tumor-specific immune activation.
- We are very satisfied with the encouraging data we have collected so far in this limited patient population and are therefore really looking forward to continuing the evaluation of INTUVAX® in a larger phase II trial that is planned to start in 2014. As we gather more survival data, in addition to tumor progression and regression data, the overall assessment of the results of our phase I/II study could potentially be even better than it already is. Therefore it will be very interesting to continue the evaluation of the patients who are still alive, says Immunicum's CEO, Jamal El-Mosleh.
About the study
The phase I/II study, initiated in February 2012, includes a total of 12 patients treated with two intratumoral injections/vaccinations with INTUVAX® after which the cancer-affected kidneys with primary tumors were removed by surgery.
One patient was excluded from the study with regards to evaluation of efficacy since the patient after inclusion was shown to lack renal cancer metastases.
Median survival after vaccination for the subgroup with poor prognosis (five patients, categorized with generally accepted Heng criteria) has currently surpassed the expected median survival with interferon-alpha treatment or modern targeted therapies (mainly tyrosine kinase inhibitors).
In the whole group of patients with metastatic renal cell carcinoma (11 patients) that have been evaluated with respect to survival, eight patients are still alive. Immunicum will therefore continue to monitor survival data after submission of the final report to the Swedish Medical Products Agency.
Current pre-clinical and clinical research point to a synergistic effect when combining immunotherapy and other treatments such as tyrosine kinase inhibitors or PD-1 inhibitors. Immunicum thus aims to closely and formally monitor tumor progression and regression data after the potential addition of tyrosine kinase inhibitors.
Detailed data will be presented at the annual ASCO-meeting in Chicago May 30 - June 3, 2014. In accordance with ASCO policy, information in the abstract and data to be presented will be kept strictly confidential until the presentation at the ASCO Annual Meeting. Immunicum will provide timely information with regards to more detailed clinical data in connection with the conference.
Immunicum's immunotherapy platforms are based on over 30 years of research in the field of transplantation immunology. The Company's shares have been traded since April 22, 2013 on NASDAQ OMX First North under the ticker IMMU.
For further information please contact:
Jamal El-Mosleh, CEO of Immunicum, +4631-41 50 53,
Redeye AB is chosen as the Company's Certified Adviser.
Tel: +468-545 013 31. www.redeye.se.
About Immunicum AB (publ):
Immunicum AB (publ) develops cancer immunotherapies. Its two main groups of therapeutic cancer vaccines, SUBCUVAX® and INTUVAX®, and the method of expansion of tumor-specific T-cells (CD70) is based on the Nobel prize awarded discovery of the dendritic cell and its central role in the activation of the specific immune response. Since the raw material consists of allogeneic dendritic cells, Immunicum's products can be produced in large scale. The vaccines are now undergoing clinical trials in renal cell carcinoma and hepatocellular carcinoma.