US-based biosciences company XBiotech has reported positive Phase III trial results of Xilonix to treat patients with advanced colorectal cancer (CRC).

Xilonix is the company’s lead monoclonal (IgG1k) antibody immunotherapy.

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The double-blind, placebo-controlled Phase III trial involved 309 patients randomised into 2:1 to be treated with Xilonix and best supportive care (BSC) against placebo, as well as BSC.

The trial was primarily focused on determining the clinical response rate (CRR) by collaborating with the European Medicines Agency (EMA) Scientific Advice Working Group to measure the efficacy of Xilonix as an anti-cancer therapy for CRC treatment.

"In this first-of-its-kind study, not only did treatment with Xilonix demonstrate clinical benefit but it was also very well-tolerated."

Results have displayed an improved clinical response for a range of symptoms associated with the disease progression and an overall survival with a lack of toxicity.

The patients recorded a gain in their lean body mass compared to non-responders with reduced fatigue and pain and an improved appetite.

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Bournemouth University visiting professor Dorset Cancer Centre consultant medical oncologist and Xilonix European Phase III trial chair Dr Tamas Hickish said: "In this first-of-its-kind study, not only did treatment with Xilonix demonstrate clinical benefit but it was also very well-tolerated, suggesting Xilonix has the potential to meet the real and urgent need for more effective, less toxic therapies for patients with advanced colorectal cancer.

"In addition, this study provides evidence that novel endpoints based on symptom recovery can serve as a predictor of overall survival benefit and therefore may be used to evaluate an anti-tumour agent in this disease."

Xilonix targets and deactivates interleukin-1 alpha (IL-1alpha), which is an inflammatory signalling molecule.

The IL-1 pathway and IL-1alpha play a key role in both local and systemic effects of cancer.

IL-1alpha in the tumour micro-environment trigger promote angiogenesis (the growth and spread of tumours) and promote symptoms such as metabolic dysregulation fatigue and anxiety associated with advanced cancer.