Midatech Pharma PLC (NASDAQ: MTP) has announced that after filing an application with the US FDA for its MTX110 development program for recurrent glioblastoma treatment, it has been awarded Fast Track designation.
MTX110 given fast track designation
Fast Track Designation is a procedure aimed to speed up the development and approval of medicines for critical illnesses that could potentially meet unmet medical needs. Drugs with this designation are eligible for more regular discussions with the FDA and possible expedited approval procedures.
The company’s CSO Dmitry Zamoryakhin said, “rGBM is a devastating cancer marked by short survival rate and universal recurrence. Receiving Fast Track designation for MTX110 is an important milestone for the development of the drug as it demonstrates the need for novel and effective treatment options for this currently universally fatal disease. MTX110, our water-soluble formulation of Panobinostat, will soon start recruitment into a Company-sponsored Phase I study in patients with recurrent GBM.”
MTC110 allows delivery of chemo doses to the tumor site
MTX110 is a soluble version of panobinostat free element that allows for convection-enhanced delivery (CED) of possible chemotherapeutic dosages straight to the tumor site by complexation with hydroxypropyl—cyclodextrin (HPBCD). Panobinostat is known as hydroxamic acid that inhibits histone deacetylase in a non-selectively (pan-HDAC inhibitor). However, low blood-brain barrier permeability and insufficient brain medication concentrations mean that the presently offered oral form of panobinostat lactate (Farydak®) is not suited for brain malignancies treatment.
The company is testing MTX110 in clinical trials for DIPG (NCT03566199, NCT04264143) and recurrent medulloblastoma (NCT04315064), as well as in preclinical trials for glioblastoma (NCT03566199, NCT04264143). To breach the blood-brain barrier, MTX110 is given directly to and surrounding area of the patient’s tumor using a catheter system. This method exposes the tumor to extremely high medication levels while reducing systemic drug concentration and the risk of toxicity plus other side effects. In addition, Panobinostat has shown remarkable potency versus DIPG tumor cells in both in vivo and in vitro models, and it was the most effective of 83 anticancer drugs examined in 14 patient-derived DIPG cell lines in a pivotal study.