CLS report to EU Horizon2020 shows continued promising survival results for imILT treatment of pancreatic cancer

Clinical Laserthermia Systems (CLS) (publ), today submitted the first part of the report to the EU that marks the conclusion of the project that CLS began in 2016, and that received just over SEK 20 million in project funding from the EU Framework Programme for Research and Innovation, Horizon 2020. The report contains confirmation of the positive results, previously announced by CLS, regarding the survival of patients with pancreatic cancer who have received imILT therapy. CLS and the two hospitals that conducted the pancreatic cancer study now plan to continue to work together and will jointly present their experience of using imILT therapy in the spring of 2019. The Portuguese Institute of Oncology in Portugal will continue to offer imILT therapy to patients with pancreatic cancer and is therefore in the process of becoming the first hospital in Europe to routinely offer this method as a treatment alternative. 

Within the framework of the project CLS has carried out three clinical studies to demonstrate the safety and administration of imILT therapy for the treatment of pancreatic cancer and breast cancer. These studies have been carried out at three hospitals in Europe: Institut Paoli-Calmettes in France, the Portuguese Institute of Oncology in Portugal (both pancreatic cancer) and Nottingham University Hospital in England (breast cancer). Recruitment to the studies closed on 31 July this year and the last patients were treated in September. 

In the interim report that CLS has now submitted to the EU each study has been reported separately. 

At the Institut Paoli-Calmettes in Marseilles, France, five patients with stage III pancreatic cancer were treated according to the study protocol. The treatment, which was performed using open surgery, was well-tolerated by the patients, and usability and safety of the equipment was excellent. One serious side effect was reported. This was related to the procedure and the difficult location of the tumor. The promising survival results that were previously announced by CLS have been confirmed in the report. 

The Portuguese Institute of Oncology in Porto, Portugal, treated four patients with stage III and stage IV pancreatic cancer. A considerably greater number of patients were recruited, but were assessed to be unsuitable for therapy due to their general health, other illnesses and external factors that CLS could not influence. In addition to safety and usability, this study also had the goal of examining treatment efficacy. 

In addition to the treatment of metastases in the liver, patients with locally advanced pancreatic cancer were also treated using open surgery. The therapy was well-tolerated by the patients, regardless of whether metastases or locally advanced cancer was treated. No serious side effects resulted from the therapy.

Five of the patients who received imILT therapy had a median survival time of 17 months. This has to be compared to the published results for locally advanced, inoperable pancreatic cancer where median survival times are significantly less than a year  – nine months in some reports. 

“It is very positive that the treatment of locally advanced pancreatic cancer has worked so well. Pancreatic cancer is notoriously difficult to treat, largely due to the delicate location of the pancreas close to major blood vessels and the duodenum. This means that with every type of treatment there is a risk of damaging these vital structures,” explains Mats Ekelund, Chief Medical Officer at CLS.  “With the survival data we have today, imILT therapy is viewed as a way forward, which is very positive. In terms of the immunological effects it is not possible to make a scientific assessment from the limited number of cases. However, from the survival data we have, I believe this to be more than sufficiently interesting to continue to work with,” summarizes Mats Ekelund, Chief Medical Officer at CLS. 

“I am looking forward to continuing to work with the doctors and the hospitals in Marseilles and Porto. We will jointly present imILT at one or more conferences in the spring of 2019, and new material to disseminate knowledge about imILT has been prepared. This material will be available early next year,” says Lars-Erik Eriksson, CEO of CLS. 

In the study to examine imILT therapy for breast cancer, which was conducted at the Nottingham University Hospital in Nottingham, England,two patients of the intended number of five patients were treated. The treatment here also went well and was without serious side effects. Both patients were alive at the time of follow-up, which was two months and ten months, respectively, after the therapy was administered. The difficulty in recruiting patients to this study was probably mainly due to the currently established breast cancer treatments being perceived as a safer choice for the patients. 

Immunostimulating Interstitial Laser Termoterapi, imILT®, is a heat-induced cancer immunotherapy for gentle and effective treatment of most types of solid cancer tumors. Treatment is administered using the CLS TRANBERG®çThermal Therapy System for image-guided thermal high-precision therapy and ablation in soft tissues. The system can be configured for MR or CT/US-guided procedures with monitoring and feedback of tissue temperature for exact therapy and ablation control. The system consists of a mobile laser unit, new innovative non-cooled laser applicators, external tissue temperature sensors and procedure-specific accessories.

The second and final part of the project report, which contains a financial statement and summary of the project, will be submitted in January 2019. The report that CLS has submitted to the EU has not been publicly released. More information about Horizon2020 is available at https://ec.europa.eu/programmes/horizon2020/

This press release has been translated from Swedish. The Swedish text shall govern for all purposes and prevail in case of any discrepancy with the English version.  

Lars-Erik Eriksson, CEO, Clinical Laserthermia Systems AB (publ)
Tel: +46 – (0)702 – 90 33 00   E-mail: lee@clinicallaser.se

Clinical Laserthermia Systems AB (publ), develops and sells the TRANBERG®|Thermal Therapy System and specially designed sterile disposable products for safe, gentle and effective treatment of cancerous tumors. The products are marketed for image-guided laser ablation and for treatment with immunostimulating interstitial laser thermotherapy, imILT®. The company, which is headquartered in Lund Sweden and have subsidiaries in Berlin, Germany and Boston, MA,USA, is listed Nasdaq First North under the ticker CLS B. Certified Adviser is Västra Hamnen Corporate Finance. Further information is available on the company’s website: www.clinicallaser.se