Periodic Reporting for period 2 - INTHER (Clinical validation and commercialization of innovative immunostimulating Interstitial Laser Thermotherapy)
Reporting period: 2017-08-01 to 2018-11-30
Among major cancer types, two are especially dangerous and disturbing: breast cancer and pancreatic cancer. The former is the most common cancer in women worldwide, with nearly 1,7 million new cases diagnosed in 2012. This represents about 12% of all new cancer cases and 25% of all cancers in women. The latter is the fourth-leading cause of cancer-related death in developed countries and has the highest mortality rate of all major cancer types with a 5-year survivability of only 3–4%. The additional danger behind all cancer cases, even if an initial tumour has been treated successfully, is the possibility of future metastasis and recurrence. Cancer cells may break away from a tumour and can travel to other areas of the body through the bloodstream or the lymph system.
The goal of the INTHER project is to bring the ground-breaking immunostimulating Interstitial Laser Thermotherapy (imILTCLS) to the market and clinical practice. This is a world’s first device-based and minimally invasive cancer immunotherapy method designed to achieve local tumour destruction and stimulate long-lasting, vaccination-like, systemic immunity against the treated form of cancer.
The studies performed to date have confirmed the therapeutic capability of the new method. In the project, the method will be further validated for the two chosen solid tumour types: pancreatic cancer and breast cancer. This will enable CLS to shorten the time to full commercialisation, obtain the clinical acceptance and fully exploit the commercial potential of the new treatment method. The clinical uptake of imILTCLS in Europe will lead to a reduction of costs associated with the treatment of solid tumours, especially surgeries, and reduction of costs related to the activation of immunotherapies.
The investigative core of the project consisted of three clinical validation studies:
o Study conducted in cooperation with Institut J. Paoli et L. Calmettes, Marseille, France
o Study conducted with Portuguese Oncology Institute of Porto, Porto, Portugal
o Study conducted with Nottingham Breast Institute, Nottingham University Hospital, Nottingham, the UK
The data from the project will play an important role in the company´s ability to bring the system and method to the market.
At the Institut Paoli-Calmettes in Marseille, France, five patients with pancreatic cancer stage III were treated in accordance with the protocol. The promising results for survival that CLS has announced in March 2018. Portuguese Institute of Oncology in Porto, Portugal, treated four patients with pancreatic cancer stage III and IV. In addition to treatment of metastases in the liver, patients with locally advanced pancreatic cancer have also been treated during open surgery. The treatment was well tolerated by the patients, whether it was metastasis or locally advanced cancer being treated. No serious side effects occurred due to treatment. Five of the patients receiving imILT treatment in the studies mentioned above have a median survival of 17 months, compared with published results for locally advanced, inoperable pancreatic cancer, which shows a median survival of significantly less than one year – in some reports 9 months. It is very positive that the treatments of locally advanced pancreatic cancer have worked so well. Pancreatic cancer is notoriously difficult to treat, much because of the pancreatic sensitive position adjacent to large blood vessels and the duodenum. This means that every type of treatment risks damaging these vital structures. With the survival data we have today, imILT treatment seems to be a way forward which is very positive. In the study of imILT treatment of breast cancer, conducted at Nottingham University Hospital in Nottingham, England, two patients out of five were treated. Here, too, treatment ended well and without serious side effects. Both patients lived during the follow-up period, which was two and ten months after treatment, respectively. For one patient, the treatment was very successful, and the tumour disappeared. For the second patient the disease was stable after treatment.
During the project, CLS has also actively performed dissemination and communication activities. In order to boost awareness of the project and our treatment among KOLs, we have participated in medical conferences and published one scientific article. The company has also published information about the project on its website and information about the clinical trials on the https://clinicaltrials.gov website.
In the project, the method has been further validated for pancreatic cancer and breast cancer. The clinical uptake of imILTCLS in Europe will lead to reduction of costs associated with the treatment of solid tumours, especially surgeries, and reduction of costs related to the activation of immunotherapies. CLS’ strategy is based on intensive efforts towards validating imILTCLS and bringing it to the market. The project has been a key step towards realizing this business strategy.