Periodic Reporting for period 4 - TLA-Gut (Novel Personalized Cellular Therapy Approach for Immune Diseases)
Periodo di rendicontazione: 2021-11-01 al 2023-03-31
The objective of the project was to close remaining gaps to market entry for TLA Gut™. TLA is a globally unique cellular technology and the first medical device with a proven clinical efficacy in selectively removing endogenous, disease-causing cells from the patient’s circulatory system, using a modified version of leukapheresis (selective removal of white blood cells). The device is designed to combat Inflammatory Bowel Disease (IBD) – a subset of Immune Mediated Inflammatory Diseases (IMIDs).
The collective name IMIDs comprises ~80 conditions (e.g. ALS, MS, acute respiratory distress syndrome, primary sclerosing cholangitis and alcoholic hepatitis) that affect roughly 10% of the global population. IMIDs, often untreatable, are caused and maintained by an imbalance of the immune system and have a combined socioeconomic effect comparable to that of infectious diseases or cancer.
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The collective name IMIDs comprises ~80 conditions (e.g. ALS, MS, acute respiratory distress syndrome, primary sclerosing cholangitis and alcoholic hepatitis) that affect roughly 10% of the global population. IMIDs, often untreatable, are caused and maintained by an imbalance of the immune system and have a combined socioeconomic effect comparable to that of infectious diseases or cancer.
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The project has delivered its main objective - TLA has obtained CE marking under MDD. We have established the TLA Gut column as the first column for targeted leukapheresis.
The activities of the project fully correspond to the expected impact. IBD has been increasing in the western world over the last decade, with an average prevalence of around 1%. The frequency is highest in North America, Northern Europe and the United Kingdom. In these areas, the incidence is approximately 15-25 cases per 100,000 citizens/year for UC and the 8-12 cases per 100,000 for CD. The clinical manifestations of IBD often start during adolescence, with peak onset ranging between 20-40 years of age.
Standard CD/UC treatments are based on an escalating pharmaceutical approach consisting of biologics and steroids. Occasionally, none-specific leukapheresis (extraction of white blood cells from blood) procedures are implemented in-spite of lacking clinically significant effects. Only 50-60% of patients achieve long-term remission using standard drug therapies, which besides having unsatisfactory efficacies are unsuitable for long-term use as they carry risks of causing severe (even debilitating) adverse effects. When drug therapies fail, patients may be forced to undergo surgical removal of the entire colon and rectum (proctocolectomy). The Quality of Life (QoL) of patients is hence severely negatively affected both before, during and sometimes even after treatment (e.g. surgery).
TLA’s has created the TLA GutTM column – the fist Targeted Leukapheresis column, and hitherto only medical device, with a proven clinical efficacy in selectively removing disease-causing cells in IBD from a patient’s circulation.
Standard CD/UC treatments are based on an escalating pharmaceutical approach consisting of biologics and steroids. Occasionally, none-specific leukapheresis (extraction of white blood cells from blood) procedures are implemented in-spite of lacking clinically significant effects. Only 50-60% of patients achieve long-term remission using standard drug therapies, which besides having unsatisfactory efficacies are unsuitable for long-term use as they carry risks of causing severe (even debilitating) adverse effects. When drug therapies fail, patients may be forced to undergo surgical removal of the entire colon and rectum (proctocolectomy). The Quality of Life (QoL) of patients is hence severely negatively affected both before, during and sometimes even after treatment (e.g. surgery).
TLA’s has created the TLA GutTM column – the fist Targeted Leukapheresis column, and hitherto only medical device, with a proven clinical efficacy in selectively removing disease-causing cells in IBD from a patient’s circulation.