In a small but important Phase 1 study, MTX110 is outperforming historic norms of progression free and overall survival

CARDIFF, UK / ACCESSWIRE / October 17, 2024 / Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, released positive patient updates on progression-free survival (PFS) and overall survival (OS) from the ongoing MAGIC-1 study of MTX110 in recurrent glioblastoma (rGBM), a lethal form of adult brain cancer.

The study (NCT05324501) is designed to evaluate the feasibility, safety and efficacy of treating rGBM patients with MTX110.

The company earlier reported patients #1 and #2 in Cohort A achieved overall survival (OS) of 12 and 13 months, respectively.

The remaining two patients in Cohort A remain on follow-up. Patient #3 has achieved 13 months OS to date, with six months progression free survival (PFS). Patient #4 has not progressed and achieved 12 months PFS and 12 months OS to date.

Glioblastoma is the most common and lethal form of brain cancer in adults with a universally fatal prognosis, particularly when it recurs. The median survival post-recurrence is 6.5 months, making any progress toward extending patients' lives a significant breakthrough.

The new data builds on earlier promising trial results with MTX110 in Diffuse Midline Glioma (DMG), and could signal a potential shift in the standard of care. The GBM treatment market was $2.5 billion in 2022, projected to grow nearly 10 percent annually through 2030.

MTX110's value may be further enhanced by its potential in DMG, a mostly pediatric and universally fatal brain cancer.

MTX110: A Novel Approach To Treating Brain Cancers

MTX110 is a proprietary combination of water-soluble panobinostat, an FDA-approved drug for multiple myeloma, and a convection-enhanced delivery (CED) pump / catheter system that delivers drug directly to and around the tumor, bypassing the blood-brain barrier which typically plays a delimiting role in allowing foreign substances, including therapeutic levels of chemotherapies, to reach inside the brain.

The CED technology allows cancer-killing MTX110 to bypass the barrier, delivering up to 100,000 times the concentrations of drug compared to oral dosing straight to the tumor site via a surgically implanted catheter and pump. This targeted approach is designed to not only increase the drug's effectiveness, but also reduce the likelihood of harmful side effects seen in systemic chemotherapy. The CED catheter and pump stay in place, eliminating the surgical need for installing new catheters for each infusion.

In addition to its unique delivery mechanism, MTX110's formulation of panobinostat also differentiates it from other therapies. Panobinostat acts as a histone deacetylase inhibitor, a class of compounds known to affect gene expression in cancer cells, slowing their growth and spread. This mechanism, combined with direct tumor delivery, provides a double-pronged approach to combating brain tumors that are otherwise highly resistant to treatment.

New Data Offers Optimism Amid Bleak Outlook For Glioblastoma

Glioblastoma is known for its aggressive nature, with a tendency to invade surrounding brain tissue and resist conventional treatments. While the standard treatment approach includes surgery, radiotherapy and temozolomide (TMZ) chemotherapy, the disease almost always recurs. With recurrent cases, options are limited, and survival times are short. According to a study published in Neuro-Oncology, median PFS for recurrent glioblastoma ranges from 1.5 to 6 months, while OS typically falls between 2 to 9 months. This grim outlook underscores the need for new therapeutic strategies, such as MTX110.

The interim data from the MAGIC-G1 study has raised hopes that MTX110 could provide a new treatment option that offers real benefits in survival without the toxicity associated with traditional chemotherapy. Importantly, the CED technology minimizes the drug's systemic exposure, potentially reducing the severity of side effects and improving the patient's quality of life during treatment.

Extending Life Expectancy In Diffuse Midline Glioma Patients

Biodexa's MTX110 promise in treating DMG, a rare but highly aggressive form of brain cancer that often affects children, has been demonstrated in a pair of Phase 1 clinical trials.

A phase 1 study conducted by the University of California, San Francisco (UCSF) involved patients with DMG and reported a median overall survival of 26.1 months. This contrasts with the historical median survival of around 10 months for patients with DMG, making MTX110's performance in this setting noteworthy.

In a separate phase 1 trial involving newly diagnosed DMG patients at Columbia University, MTX110 demonstrated, after only two infusions per patient, similarly encouraging results, improving median overall survival to 16 months. These results reinforce MTX110's potential to change the treatment landscape for DMG, a cancer that, despite being rare, carries devastating prognoses.

A Breakthrough Candidate For Aggressive Brain Cancers?

Biodexa Pharmaceuticals has strategically positioned MTX110 as a potential game-changer in the treatment of aggressive brain cancers. Both rGBM and DMG are devastating conditions, with very few effective treatments currently available. The early trial results for MTX110 suggest it may offer patients the chance of longer survival and better outcomes than standard therapies can provide.

The ongoing phase 1 trials continue to gather crucial data. If these positive trends continue, MTX110 could progress to later-stage clinical trials and possibly become a new standard of care for rGBM and DMG patients. Biodexa's innovative approach, utilizing CED for targeted drug delivery, could position the company as a leader in developing treatments for cancers with historically poor prognoses. As the research advances, MTX110 remains one to watch in the fight against aggressive brain tumors.

Featured photo by Salah Uddin on Istockphoto

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SOURCE: Biodexa Pharmaceuticals