Biodexa Pharmaceuticals ( BDRX ) , developing MTX110 for Diffuse Midline Glioma (DMG) in pediatric patients and for Recurrent Glioblastoma (rGBM) in adults, says early trials of MTX110 in both brain cancers show promise in extending survival rates beyond those reported in previously published studies.

The main chemotherapy agent of MTX110, panobinostat, was initially used to treat multiple myeloma and received FDA approval in 2015. 

The company is reworking the chemotherapy agent by changing its delivery method and leveraging Convection Enhanced Delivery (CED) technology.

Researchers discovered that the original formulation of panobinostat could block enzymes involved in cancer cell growth, exhibiting high potency against brain stem tumor cells in vitro and in vivo. 

However, the original oral tablet form is insoluble and incapable of crossing the blood-brain barrier at therapeutic levels – making it an ineffective treatment method for brain cancers.

The distinctive feature of MTX110 is that it combines a water-soluble form of panobinostat with a CED device that delivers the drug directly to the brain tumor through a surgically implanted catheter and refillable pump. 

Biodexa says the drug achieves high drug concentrations within the tumor while limiting systemic exposure.

The proof-of-concept phase 1 clinical trial showed a median overall survival of 26 months, compared to a historical overall survival rate of 10 months. 

Similarly, a phase 1 trial involving newly diagnosed DMG patients showed that MTX110 treatment increased median overall survival to 16 months from a historical overall survival rate of 10 months.

Biodexa reports that the ongoing MAGIC-G1 phase 1 trial in recurrent GBM patients is currently showing considerable progress with the completion of recruitment for cohort A of the study. 

The first patient survived for 12 months, and three remain in the study. The expected topline results for progression-free survival from cohort A will be available in Q2 of 2024. 

The retrospective analysis of 299 patients with similar recurrent GBM disease showed a median overall survival of only 6.5 months after the recurrence of GBM cancer.

Price Action: BDRX shares are up 66.5% at $1.43 on the last check Thursday.

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