Midatech Pharma Plc (NASDAQ: MTP) has announced today the promising headline results from Phase I study in patients with Diffuse Intrinsic Pontine Glioma (DIPG). The biotechnology company has revealed the results at the University of California, San Francisco (UCSF). A total of seven patients were enrolled in this UCSF study. They all were newly diagnosed with Diffuse Intrinsic Pontine Glioma (DIPG).
Before the start of MTX110 treatment, all the patients were given the focal external beam radiation therapy for four to 14 weeks. MTX110 was injected directly into the tumor via a micro-catheter using convection-enhanced delivery (CED) with gadolinium-enhanced intra-operative MRI to guide and track drug distribution to the tumor. All the patients were given the 12 cycles of treatment every four to eight weeks.
The level of doses was increased with the increase in the level of tolerance at a concentration of 30μM MTX110 and then with higher drug concentrations of 60μM and 90μM as the sixth and seventh dose increments, respectively were given to the patients.
The primary purpose of the Phase II study is to determine the dosage level which is to be used to study the safety and efficacy of MTX110 in patients with DIPG. The study data showed that the dosage of 60μM and 90μM of MTX110 is proven to be very useful in treating patients in the course of 12 infusions in Phase II. The dosage level depends on the tolerance level of the patient.
Midatech Pharma Plc (NASDAQ: MTP) shares were trading down -6.54% at $2.00 during the trading session of Friday. Midatech Pharma Plc (MTP) share price went from a low point around $0.86 to briefly over $7.52 in the past 52 weeks, though shares have since pulled back to $2.00. MTP market cap has remained high, hitting $25.23 million at the time of writing.
The median overall survival based on Kaplan Meier analysis was 26.06 months and overall survival at 12 months (OS12) was 71.4% (five of seven patients alive) at the interim cut-off date (30th September 2020). As per the study, three patients remained alive and are continuously monitored.
UCSF’s study endpoint was not a survival rate and the date hasn’t revealed the effect of MTX1010 on the survival rate in patients with Diffuse Intrinsic Pontine Glioma (DIPG). The given Phase II trial is anticipated to analyze overall survival at 12 months as the primary endpoint in 19 evaluable patients. Diffuse Intrinsic Pontine Glioma (DIPG) is a primary brain tumor starting in the middle of the brain stem, is diffusely invading. This tumor cannot be surgically removed.