Biodexa Reports 12 Month Survival in MAGIC-G1 Study of MTX110 in Recurrent Glioblastoma Patients
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Insights
The reported 12-month survival for a patient in the MAGIC-G1 study of MTX110 represents a significant milestone in the treatment of recurrent glioblastoma (rGBM), a disease known for its poor prognosis. The median overall survival for rGBM patients is typically around 6.5 months, as per the Journal of Neuro-Oncology, which places the survival update from Biodexa in a potentially favorable light when compared to historical data. The use of convection enhanced delivery (CED) for administering MTX110 could be a game-changer, as this method allows for direct delivery of the drug to the brain tumor, potentially increasing efficacy and reducing systemic toxicity.
From a research perspective, the safety profile of MTX110 is also noteworthy. The absence of drug-related adverse events within the initial 30 days is promising, considering the aggressive nature of GBM and the toxicity often associated with treatments. However, it's crucial to consider the small cohort size and the open-label design of the study, which may limit the generalizability of the findings. Future studies with larger sample sizes and controlled conditions are necessary to validate these preliminary results.
As an oncologist, the clinical progress of MTX110 is of particular interest due to the dire need for effective treatments in rGBM. The reported survival of 12 months for a patient is encouraging, as it suggests a potential doubling of the life expectancy post-recurrence. MTX110, administered via CED, may offer a targeted therapeutic approach, which is crucial in managing a disease that is typically resilient to conventional treatments. The focus on the feasibility and safety of intermittent infusions is also critical, as it addresses the practical aspects of treatment administration that can significantly impact patient quality of life.
Moreover, the individualized dosing, as evidenced by the different micromolar concentrations used, highlights the precision medicine approach in oncology. This tailored treatment strategy could lead to better outcomes by optimizing the dose for efficacy while minimizing adverse effects. The ongoing monitoring of the remaining patients will be essential to establish the dose-response relationship and long-term safety profile of MTX110.
The positive survival data from the MAGIC-G1 study could have a substantial impact on Biodexa Pharmaceuticals' market position, particularly in the niche market of rare/orphan brain cancers. Given the unmet medical need in rGBM, MTX110's progress through clinical trials could be a significant driver of investor confidence and stock valuation for Biodexa. The biopharmaceutical sector places a high premium on innovative treatments that address high-mortality conditions such as GBM and Biodexa's focus on this area could differentiate it from competitors.
Investors and stakeholders should monitor the progression of Cohort A patients and subsequent cohorts closely, as further positive results could catalyze additional investments and partnerships. However, it is essential to balance optimism with caution, as the biotech industry is known for its volatility and the success of clinical trials is never guaranteed. The long-term impact on Biodexa's financials will depend on the completion of clinical trials, regulatory approvals and the ability to successfully commercialize MTX110.
Biodexa Pharmaceuticals PLC
Biodexa Reports 12 Month Survival in MAGIC-G1 Study
of MTX110 in Recurrent Glioblastoma Patients
CARDIFF, United Kingdom, February 8, 2024 (GLOBE NEWSWIRE) -- Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs including Type 1 diabetes and rare/orphan brain cancers, today provided survival updates from its MAGIC-G1 study (NCT05324501) of MTX110 in patients with recurrent glioblastoma (“rGBM”) being conducted at Duke Cancer Institute and Baptist MD Anderson Cancer Center.
In October 2023, Biodexa announced completion of recruitment of Cohort A of an ongoing open-label Phase I dose-escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (“CED”) via implanted refillable pump and catheter. Because no drug-related adverse events were observed within the first 30 days from start of treatment, the minimum number of four patients were recruited into Cohort A.
Patient #1 received weekly infusions of 60µM of MTX110 and survived for 12 months from the start of treatment (OS=12).
Patients #2, 3 and 4 each received weekly infusions of 90µM of MTX110, the expected optimum dose, and remain in the study.
GBM universally recurs and once it does median overall survival according to a retrospective analysis of 299 patients reported in the Journal of Neuro-Oncology is 6.5 months1. Currently, no standard of care is established for rGBM.
About Glioblastoma Multiforme (GBM)
GBM is the most common and devastating primary malignant brain tumour in adults with incidence of 3 -4 per 100,000 population2. Standard of care for treatment of GBM is typically maximal surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy. Notwithstanding, the multidisciplinary approach, almost all patients experience tumour progression with nearly universal mortality.
About MTX110
MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-β-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for recurrent Glioblastoma (NCT05324501), Diffuse Midline Glioma (“DMG”) (NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of Leptomeningeal Disease. MTX110 is delivered directly into and around the patient's tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DMG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).
- J Neurooncol. 2017; 135(1): 183–192
- Cancers | Free Full-Text | Epidemiology of Glioblastoma Multiforme; Literature Review (mdpi.com)
For more information, please contact:
Biodexa Pharmaceuticals PLC |
| Stephen Stamp, CEO, CFO |
| Tel: +44 (0)29 20480 180 |
| www.biodexapharma.com |
Edison Group (US Investor Relations) |
| Laine Yonker |
| Tel: +1 (610) 716 2868 |
| Email: lyonker@edisongroup.com |
About Biodexa Pharmaceuticals PLC
Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programmes include tolimidone, under development as a novel agent for the treatment of type 1 diabetes and MTX110, which is being studied in aggressive rare/orphan brain cancer indications, and
Tolimidone is an orally delivered, potent and selective inhibitor of lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.
MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumour, by-passing the blood-brain barrier and potentially avoiding systemic toxicity.
Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com.
Forward Looking Statements
Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Examples of forward-looking statements include, among others, statements we make regarding our pre-clinical data and clinical trials. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.
Reference should be made to those documents that the Company shall file from time to time or announcements that may be made by the Company in accordance with the rules and regulations promulgated by the United States Securities and Exchange Commission, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning the Company are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, the Company does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.
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