Midatech Pharma PLC is delighted to announce that their Phase I study of MTX-110 in recurrent glioblastoma (NCT 05324501) will continue with a planned dose escalation, following a positive recommendation from the study’s Data Safety Monitoring Board (DSMB) and completion of one month of treatment with MTX-110 in the first patient. This is an exciting development in the advancement of treatments for rGB.
The MAGIC-G1 study is an innovative, open-label, dose escalation study that seeks to assess the feasibility and safety of intermittent infusions of MTX-110. Administered through an implanted refillable pump and catheter via convection enhanced delivery (CED), this exciting study will recruit two cohorts of at least four patients each—the first cohort receiving MTX-110 only and the second cohort receiving MTX-110 in combination with lomustine. Join us as we explore the potential of this cutting-edge technology!
On 11 January 2023, the Data Safety Monitoring Board (DSMB) reviewed the available data on the first patient in the study of MTX-110 and recommended dose escalation to 90uM. This dose is anticipated to be the optimal dosage of MTX-110 and is currently being used in the ongoing Phase I study of patients with Diffuse Intrinsic Pontine Glioma (DIPG) at Columbia University in the USA. The first patient in the study had received four 48-hour infusions of 60uM MTX-110 via direct-to-tumour delivery over a period of four weeks, with no treatment-associated adverse events reported.
Patient 1 is continuing their treatment, while Patient 2 is set to join the study protocol by the end of January 2023, receiving a 90uM dose. Both patients are on their way to achieving successful results from the treatment.
The MAGIC-G1 study has achieved a significant milestone with no adverse events observed in the first study patient. This allows for a dose escalation approach to reach the optimal concentration of MTX-110. With the safety profile of the higher dose still to be determined, a minimum of three more patients need to be recruited before further progression can be made. Dr Dmitry Zamoryakhin, MD, MBA, CSO of Midatech, commented positively on the progress so far, stating, “This represents encouraging progress for the MAGIC-G1 study.”
About Glioblastoma (“GB”)
Glioblastoma (GB) is an aggressive and devastating primary malignant brain tumour that affects adults, accounting for 14.3% of primary brain and central nervous system neoplasms. With an incidence of 3.2 per 100,000 population in the United States, 12,300 people are diagnosed with GB every year. Treatment typically involves a multidisciplinary approach, including maximal surgical resection, radiotherapy, temozolomide chemotherapy, and the Optune® device. Despite this, the median survival from initial diagnosis is only 21 months.
About MTX110
MTX110 is a revolutionary water-soluble form of panobinostat free base that is designed to treat brain cancers like diffuse intrinsic pontine glioma (DIPG) and medulloblastoma. By complexing with hydroxypropyl-β-cyclodextrin (HPBCD), MTX110 allows for convection-enhanced delivery (CED) directly to the site of the tumour at potentially chemotherapeutic doses. As a pan-HDAC inhibitor, panobinostat has demonstrated high potency against DIPG tumour cells in vitro and in vivo, and is the most promising of 83 anticancer agents tested in 14 patient-derived DIPG cell lines. By delivering MTX110 directly into and around the tumour via a catheter system, it is possible to bypass the blood-brain barrier and deliver very high drug concentrations to the target area. In doing so, the risk for systemic drug levels and related side effects is minimized. MTX110 is currently being evaluated through clinical trials for DIPG, recurrent medulloblastoma, and preclinically for glioblastoma.
About Midatech Pharma PLC
Midatech Pharma PLC is a revolutionary drug delivery technology company that is set to transform the way medicines are delivered and distributed. With its proprietary and innovative drug delivery technologies, Midatech combines approved and development medications to create products that have the potential to significantly improve the lives of patients. Listed on both the London Stock Exchange AIM and the NASDAQ, Midatech is making strides in improving bio-delivery and bio-distribution for the better.
Our team has achieved an impressive feat – three cutting-edge technologies have been developed in-house and successfully utilized in clinical trials, demonstrating their ability to revolutionize the delivery of medications to sites of disease. Each platform is unique, leveraging a distinct mechanism to maximize efficacy and bring about real, tangible results. Our technology is leading the way in advancing healthcare.
Introducing Q-Sphera™, MidaSolve™ and MidaCore™, three revolutionary micro and nanotechnologies for sustained, targeted drug release. Our disruptive Q-Sphera™ platform can prolong and control the release of therapeutics for weeks to months, while MidaSolve™ breaks down insoluble drugs for direct, local administration into tumors. Finally, MidaCore™ targets medications to areas of disease for maximum efficacy.
Midatech offers an innovative platform for creating multiple drug assets, supported by an impressive patent portfolio of 36 families, 120 granted patents and 70 pending applications. Located in Cardiff, UK, the company’s headquarters and research and development centre is equipped to provide cutting-edge solutions to the healthcare industry.
Forward-Looking Statements
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