The IOZK would like to answer some frequently asked questions here.
What does an individualised therapy mean?
The tumour-specific immune therapy is an individual, patient-adapted therapy. Through an autologous vaccine the immune system is activated and enabled to take up the fight against the cancer. This means that each individual patient receives a unique therapy tailored according to their physical disposition, genetic makeup, and medical history.
For this an autologous, patient-specific vaccine is produced according to the European Medicines Act and “Good Manufacturing Practice” (GMP) regulations for each individual patient as a personalised medicinal product. Thus patients at the IOZK receive the best possible immune therapy, tailored for them personally.
What is an “individueller Heilversuch”?
The IOZK treats patients under the German “individueller Heilversuch” regulation. There is no direct translation for this term or the German legalities associated with it, but the term can best be described as compassionate use treatment.
This approach is part of the medical therapeutic freedom. It represents a procedure which is primarily performed to the benefit of the patient when all other therapeutic options have been exhausted or which can be started earlier on one’s own account. Other than in clinical trials, the primary objective is not to gather general data on the patient’s response. There are no clinical values that need to be attained. A variation of this is a series of “Heilversuche”, where several of these treatments are performed in parallel or sequentially.
Does the IOZK adhere to formal regulations?
The tumour immunotherapy treatment at the IOZK is approved according to the Medicines Act §13. All services are charged according to the medical fee schedule (the German GebührenOrdnung für Ärzte – GOÄ).
Prof. Schirrmacher, Dr. Lorenzen, Prof. Van Gool and Dr. Stuecker published a review in Austin Oncology Case Reports which describes and explains the specific immunotherapy strategy that has been developed at the IOZK in Cologne.
- A New Strategy of Cancer Immunotherapy Combining Hyperthermia/Oncolytic Virus Pretreatment with Specific Autologous Anti-Tumor Vaccination
Prof. Stefaan Van Gool is specialised in paediatric oncology – the treatment of children with brain tumours is a focus at the IOZK. A recent article in the Washington Post shows that this treatment is being noticed internationally by affected parents.
The Deutsches Ärzteblatt informs about a clinical study where patients with a Ductal Carcinoma in Situ (DCIS) were injected with multiple DC vaccines before their operation. The DC vaccines were proven to be safe, well tolerated, and effective: there were no detectable cancer cells in the tumour in one in four patients at the point of the operation.
The Magazine Spektrum der Wissenschaft published an interesting article on the current status of the immune therapies against cancer, written by American medical journalist Karen Weintraub.
The German Society for Hyperthermia held its 20th Congress from 30.09.2016 to 02.10.2016 in Berlin. Research findings as well as case studies were presented.
Dr. Bettina Weigelin (Department of Cell Biology, RIMLS, Radboud University Medical Center, Nijmegen/The University of Texas MD Anderson Cancer Center, Houston) presented video evidence from living cells showing that the interaction between immune cells and the attack of tumour cells at elevated body temperature shows a higher intensity.
Prof. Elizabeth Repasky, PhD (Professor of Oncology am Department of Immunology vom Roswell Park Cancer Institute) proved in her research that moderate whole body hyperthermia has a positive impact on immunological tumour therapy.
Prof. Dr. Marion Schneider (Sektion Experimentelle Anästhesiologie, Universitätsklinikum Ulm) presented her results on the on the immune reaction of macrophages under different different conditions elevating body temperature. This shows the positive influence of moderate hyperthermia, also in combination with antiinflammatory factors.
The first tumour immunology symposium at the Catholic University Leuven in Belgium took place from 12-14 September. The symposium focussed on results from current research and the therapy options resulting from these. In a presentation titled "Cancer cell death with a twist: Towards next-generation dendritic cell immunotherapy". Dr. Abhishek Garg (from the research group of Prof. Dr. Patrizia Agostinis, Catholic University Leuven), the IOZK was introduced as partner and centre for translation.
Prof. Schirrmacher has published a review on "Fifty Years of Clinical Application of Newcastle Disease Virus" in Biomedicines.
Our new FAQ information booklet for patients is now available on the "Patient Information" section of our website. As our therapy is quite complex, we would like to answer some questions that many patients have. We will gladly answer further questions in a consultation.
Prof. Schirrmacher holds the keynote lecture at the annual meeting of the "Dutch Tumor Immunology Meeting (DTIM)" on 10 June with the title "Oncolytic virus-enhanced immunotherapy of cancer"
Prof. Van Gool has coauthored a scientific paper about a special dendritic cell preparation method.
Dr. Dirk Lorenzen presented the treatment concept of the IOZK to interested investors and hospital managers in Shengzhou and Shanghai. He also gathered information about the local cancer hospitals as well as specialised research centres and current developments.
Prof. Schirrmacher, Head of Tumour Immunology at the IOZK, has published a review in the "International Journal of Oncology" on cancer-reactive memory T-cells from bone marrow and their therapeutic potential.
- Cancer-reactive memory T cells from bone marrow: Spontaneous induction and therapeutic potential (Review)
Prof. Dr. Stefaan Van Gool has joined the IOZK.
Dr. van Gool is an internationally renowned immunologist who was actively involved in research at the University of Leuven in Belgium for the past 20 years. His research focus has been on:
- Paediatric neuro-oncology and histiocytic disorders
- Tumour immunology: preclinical research and clinical studies on brain tumours
- Long-term effects of chemotherapy
An important reason for his move to the IOZK was the manufacturing authorisation granted to the IOZK in May for the first autologous anti-tumour vaccine. “I am delighted to continue working in my area of interest. The manufacturing authorisation now makes it easier to provide patients with this therapy. At the same time, I realise that exciting new developments in preclinical research can be translated into clinical practice with the future-oriented team and network of the IOZK,” said Dr. van Gool.
New antibodies for immunological cancer therapy have been approved in Germany. These antibody therapies support tumour-specific immune cells fighting cancer cells. These are known as checkpoint inhibitor antibodies: PD-1 antibody (Nivolumab / trade name: Opdivo®) and PD-L-1 antibody (Pembrolizumab / trade name: Keytruda®),
A case study on the longer-term survival of a patient with breast cancer is published in the british journal “Immunotherapy”.
- Long-term survival of a breast cancer patient with extensive liver metastases upon immune and virotherapy: a case report
IOZK launches new website.
The IOZK received the GMP certification as well as the manufacturing authorisation in accordance with the Medicines Act for ATMPs for its autologous tumour vaccine in combination with an oncolytic virus.
The Paul Ehrlich Institute awards the Paul Ehrlich- und Ludwig Darmstaedter-Preis 2015 for special achievements in immune therapy.
Prof. Schirrmacher publishes an e-book on virus-mediated anti-tumour therapy.
The IOZK publishes a case report on the successful treatment of metastasised prostate cancer in “Oncology Letters”.
- Long‑term remission of prostate cancer with extensive bone metastases upon immuno‑ and virotherapy: A case report
The UNESCO-L’Oreal Prize for “Women in Science” in the area medicine and immunology is awarded to Prof. Kayo Inaba of the Graduate School of Biosciences at the Kyoto University in Japan. Her field of research is dendritic cells. She was the first scientist who could prove that these cells can be primed outside the body and then reinjected to raise an immune response.
“Science” names immunotherapy for the treatment of cancer as the Breakthrough of the Year 2013. According to scientists, the studies published in 2013 show a clear turning point for the importance of immunotherapies.
Current development of tumour detection in our laboratory: The IOZK has been working with current laboratory methods to detect tumours at an early stage as well as monitoring the course of a patient’s cancer. These laboratory tests have successfully been evaluated at the University of Tübingen.
"Will Dendritic Cell Subsets help us address the challenges of Cancer, Autoimmunity and Viral Diseases?“ The lecture by Jacques Banchereau on the importance of the different subtypes of dendritic cells in malignant and infectious diseases.
- Video via YouTube (National Institutes of Health)
Nobel Prize 2011 awarded for research on immune therapies. The immunologists Ralph Steinman. Bruce Beutler, and Jules Hoffmann were awarded the Nobel Prize for medicine for the discovery of basic immunological mechanisms which form the basis of an immunotherapy against cancer.