BMX-001 is BioMimetix’s leading candidate to treat several cancer types. Credit: Firstsignal via Getty Images.

BioMimetix has announced that its BMX-001 combined with radiotherapy and temozolomide has increased median survival by 6.6 months in glioma patients. 

The candidate also reduced radiation-induced cognitive issues and improved white matter integrity. 

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The clinical-stage biotech announced results from its Phase II (NCT02655601) study which is investigating the candidate in high-grade glioma (HGG). 

The multi-institutional, randomised trial is evaluating BMX-001 in combination with radiotherapy and temozolomide. The trial enrolled 160 subjects with newly diagnosed HGG, 145 of which completed protocol treatment. 

The primary outcome of the study measured overall survival, with secondary efficacy outcomes including safety and tolerability, and progression-free survival.  

The data was presented at the Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada, from 16 to 19 November 2023.  

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In the announcement accompanying the data, lead principal investigator Katy Peters said: “Patients with high-grade glioma are challenging to treat because the disease grows quickly, ultimately, outcomes are very poor for these patients and often carry an unfavourable prognosis.” 

BioMimetix is a clinical-stage biotech company focused on the development of metalloporphyrins, which is a novel drug class designed for the treatment of cancer patients.  

BMX-001 is its lead candidate that modulates cellular signalling pathways by inhibiting NFkB and HIF-1a, enhancing tumour response to radiation therapy and inhibiting tumour regrowth. The candidate has shown promise in other cancer types, including head and neck cancer, anal cancer, and rectal cancer. 

BioMimetix was granted fast track designation by the US Food and Drug Administration (FDA) for the investigation of BMX-001 in combination with radiotherapy and temozolomide in May 2020. 

According to GlobalData’s Pharmaceutical Intelligence Centre, BioMimetix has two pipeline candidates and is currently running six clinical trials across several different indications. The company has also received up to $2.4m in grants in the last three years to advance its drug candidates. 

As per a GlobalData report, the diagnosed incident cases of brain cancer are expected to increase in eight major markets, which include the US, France, Germany, Italy, Spain, the UK, Japan, and urban China. The report estimates that cases will increase from 121,646 in 2020 to 147,148 in 2030, at an annual growth rate (AGR) of 2.10%. 

GlobalData is the parent company of Clinical Trials Arena.