# Midatech Pharma’s IND application for a Phase 1 study of MTX110 has been cleared by the US FDA

- Link: https://www.directorstalkinterviews.com/midatech-pharmas-ind-application-for-a-phase-1-study-of-mtx110-has-been-cleared-by-the-us-fda/4121038315
- Published: 2021-12-13T10:47:24+00:00
- Author: Amilia Stone

**Midatech Pharma PLC** (LON:MTPH; Nasdaq: MTP), a drug delivery technology company
focused on improving the bio-delivery and biodistribution of medicines, has announced
that its Investigational New Drug (IND) application for a Phase 1 study of MTX110,
a panobinostat complex to be administered by convection enhanced delivery in patients
with recurrent glioblastoma multiforme (rGBM), has been cleared by the US FDA. Accordingly,
Midatech has initiated preparations for a study start in the first half of 2022.

Employing the Company’s MidaSolve™ technology, MTX110 solubilises panobinostat, 
a histone deacetylase (HDAC) inhibitor currently used in the treatment of multiple
myeloma. In a liquid formulation as MTX110, panobinostat can be delivered directly
to a patient’s tumour under constant pressure via a catheter system (Convection 
Enhanced Delivery, or “CED”) thereby bypassing the blood-brain barrier and allowing
for high drug concentrations and broader drug distribution in and around the tumour
while simultaneously minimising systemic toxicity and other side effects. Panobinostat
has demonstrated high potency against patient-derived tumour cells in _in vitro_
and _in vivo_ models.

GBM is the most common and aggressive form of brain cancer in adults, usually occurring
in the white matter of the cerebrum. Treatments include radiation, surgical resection
and chemotherapy although, in almost all cases, tumours recur. There are approximately
2-3/100,000^((1)) diagnoses of GBM per annum. Survival with standard of care treatment
ranges from approximately 13 months in unmethylated MGMT patients to approximately
30 months in highly methylated MGMT patients^((2)). Glioblastoma is an intractable
brain cancer.

The primary objective of the Phase I study will be to assess the safety and tolerability
of MTX110 in patients with rGBM. The study is expected to include two clinical centres
in the US and to begin recruiting H1 2022.

> **Dmitry Zamoryakhin, Chief Scientific Officer of Midatech Pharma, said**:
> “Our solubilising technology in combination with a CED system offers the potential
> to deliver significantly higher doses of panobinostat, a potent HDAC inhibitor,
> directly to the tumour. Importantly, this targeting approach is designed to limit
> systemic circulation of drug and therefore toxicity. This signal finding Phase
> I study could point the way to a new treatment paradigm for this intractable brain
> cancer.” 

 1. _American Association of Neurosurgeons_
 2. _Radke et al (2019). Predictive MGMT status in a homogeneous cohort of IDH wildtype
    glioblastoma patients. Acta Neuropathologica Communications 7:89 Online: https://
    doi. org/10.1186/s40478-019-0745-z_

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