Midatech Pharma PLC-ADR (NASDAQ: MTP) is racing for the top in the premarket hours this morning, and for good reason. The company announced positive data from a clinical trial surrounding its MTX110 candidate as a potential option for patients with Diffuse Intrinsic Pontine Glioma, or DIPG. Here’s what’s going on:
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MTP Stock Climgs On Data
In the press release, Midatech Pharma provided data from the Phase 1 UCSF study. During the study, the company worked to assess the safety and efficacy of MTX110 in patients with DIPG. The company said that preliminary, high-level data from the study suggests the best dose is between 60μM and 90μM of MTX110, depending upon patient tolerance over the course of 12 infusions in Phase II.
In the release, MTP said that it recruited a total of seven patients into the study. Each of the patients was newly diagnosed with DIPG. Moreover, all patients received focal external beam radiation therapy for between four and 14 weeks before commencement of the experimental treatment.
Moreover, patients were only eligible if there was a pontine location of the tumor with diffuse involvement of at least two thirds of the pons and no evidence of metastatic, or traveling, disease.
The company said that MTX110 was administered directly into the tumor via a micro-catheter using convection enhanced delivery with gadolinium-enhanced intra-operative MRI to guide and track drug distribution to the tumor.
MTP explained that at the interm cutoff date, median overall survival came in at 26.06 months with overall survival at 12 months being 71.4%, or five of seven patients. The company said that as of today, three patients remain alive and continue to be monitored.
In a statement, Sabine Mueller MD PhD, Principal Investigator of the UCSF study, had the following to offer:
The study has determined a proposed dose range for MTX110 for Phase II and has shown that repeated delivery of MTX110 via CED is feasible and safe. In an upcoming Phase II study efficacy in this patient population will be assessed.
The above statement was followed up by Steve Damment, EVP R&D of MTP. Here’s what he had to say:
DIPG is a devastating pediatric brain cancer with limited treatment options and very poor outcomes. The overall survival data from this Phase I study are encouraging, although further study of MTX110 in DIPG is required to establish whether it can make a difference to these patients and their families.
This News Is Massive
Midatech Pharma’s news today is incredible. DIPG is a primary brain tumor that arises in the pons, or middle of the brain stem. Unfortunately, this type of cancer cannot be surgically removed and current treatment options lack efficacy. In fact, the 12 month survival rate in patients with DIPG (mostly children) sits at about 35%.
While survival wasn’t an endpoint in the clinical trial, with a 12 month survival rate amongh the first seven patients being over 70%, there’s quite a bit of promise in this treatment candidate. Keep in mind that by the year 2024, the DIPG market is expected to grow to be worth around $1 billion annually.
With few treatment options and those that are available being widely ineffective, MTP has the potential to take this market by storm should the data continue to be this positive. As a result, the company could be sitting on a blockbuster treatment option, making MTP stock one to watch closely.
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