# Midatech Pharma Phase I study of MTX-110 in rGB will continue with a planned dose escalation

- Link: https://www.directorstalkinterviews.com/midatech-pharma-phase-i-study-of-mtx-110-in-rgb-will-continue-with-a-planned-dose-escalation/4121097556
- Published: 2023-01-12T07:38:02+00:00
- Author: Amilia Stone

**Midatech Pharma PLC** (LON:MTPH; Nasdaq: MTP), an R&D biotechnology company focused
on improving the bio-delivery and biodistribution of medicines, has announced that
following completion of one month of treatment with MTX-110 in the first patient,
its 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.

The Phase I study, the MAGIC-G1 study, 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; the
first cohort will receive MTX-110 only and the second cohort will receive MTX-110
in combination with lomustine.

The first patient in the study was dosed at 60uM of MTX-110 via direct-to-tumour
delivery and has received four 48-hour infusions over a period of four weeks. No
treatment-associated adverse events were noted in the patient during this period.
Following successful completion of the first month of treatment, the DSMB reviewed
the available data on 11 January 2023 and recommended dose escalation in the study
to 90uM. This dose is expected to be the optimal one of MTX-110 and is the one currently
being used in the ongoing Phase I study of patients with diffuse intrinsic pontine
glioma (“DIPG”) at the Columbia University, USA.

Patient 1 continues treatment as per the study protocol and patient 2 is expected
to start treatment by the end of January 2023 and will receive the 90uM dose.

> **Commenting, Dr Dmitry Zamoryakhin, MD, MBA, CSO of Midatech Pharma, said**: “
> _This represents encouraging progress for the MAGIC-G1 study. As the study protocol
> is based on an accelerated dose escalation approach, with no adverse events seen
> in the first study patient we are now able to escalate the dose to the concentration
> that is expected to be optimal in the development of MTX-110. Depending on the
> safety profile of the higher dose, the study will need to recruit a minimum of
> 3 more patients before possible progression to the next cohort_.”

**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)).

Currently, no standard of care is established for rGB.

**Sources:**

(1) Low JT, Ostrom QT, Cioffi G, Neff C, Waite KA, Kruchko C, Barnholtz-Sloan JS.
Primary brain and other central nervous system tumors in the United States (2014-
2018): A summary of the CBTRUS statistical report for clinicians. Neurooncol Pract.
2022 Feb 22;9(3):165-182. doi: 10.1093/nop/npac015. PMID: 35601966; PMCID: PMC9113389.

(2) Stupp R, Taillibert S, Kanner AA, et al. Maintenance Therapy With Tumor-Treating
Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical
Trial. JAMA : the journal of the American Medical Association. 2015;314(23):2535-
2543.

Chinot OL, Wick W, Mason W, et al. Bevacizumab plus radiotherapy-temozolomide for
newly diagnosed glioblastoma. N Engl J Med. 2014;370(8):709-722.

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