Biodexa to Present Recruitment and Treatment Update in Phase 1 Study of MTX-110 (MAGIC-G1 Study) in Patients with Recurrent Glioblastoma at 2023 Annual European Association of Neuro-Oncology Meeting (EANO)

Biodexa Pharmaceuticals PLC
(“Biodexa” or the “Company”)

Biodexa to Present Recruitment and Treatment Update in Phase 1 Study of MTX-110 (MAGIC-G1 Study) in Patients with Recurrent Glioblastoma at
2023 Annual European Association of Neuro-Oncology Meeting (EANO)

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain, is pleased to announce that it will be presenting an update on the recruitment and treatment of patients in the ongoing Phase 1 study of MTX-110 (also known as MAGIC-G1 study) in patients with recurrent glioblastoma (rGB) during a poster session on  22 September 2023, at the 2023 annual EANO meeting in Rotterdam, the Netherlands (NCT 05324501).

MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX-110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of four patients; while patients in both cohorts will receive MTX-110 via intermittent repeated CED infusions, patients in the second cohort will be allowed CED catheter repositioning upon first in-study clinical and/or radiographic confirmed progression.

As of the time of this announcement, three patients have been dosed in the first cohort of the study. No dose-limiting toxicities have been observed at any dose level; and all study-related, non-surgical  adverse events were grade 1 or 2 and correlated with the location of the lesion being treated.

Patient 1 has received 13 treatment cycles over 19 weeks of study treatment period, whereas patient 2 received 10 cycles over 13 weeks of study treatment period; patient 3 has been recently enrolled and continues to receive treatment.

Commenting, Dr Dmitry Zamoryakhin, MD, MBA, CSO of Biodexa, said: “We are pleased with the progress of the study and collaboration with our investigational sites. No observed dose limiting toxicities is an encouraging signal that justifies continuation of the development of MTX-110 for treatment of this devastating disease with high unmet medical need.”

About Glioblastoma (“GB”)

GB is the most common and devastating primary malignant brain tumour in adults encompassing 14.3% of all primary brain and central nervous system neoplasms⁽¹⁾. With an incidence of approximately 3.2 per 100,000 population in the USA, approximately 12,300 people in the USA will be diagnosed with GB per annum. Standard of care for treatment of GB is typically maximal surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy with or without the Optune device. Notwithstanding, the multidisciplinary approach, almost all patients experience tumour progression with nearly universal mortality. The median survival from initial diagnosis is less than 21 months⁽²⁾.