The company confirms Phase II Dose and encouraging survival data.
Midatech Pharma Plc (MTP) was one of the leading stocks today popping up to 42% in the premarket. The stock rallied after the company announced positive headline results from its Phase 1 study in MTX110 which was conducted among Diffuse Intrinsic Pontine Glioma (DIPG) patients.
Midatech is currently trading with a bullish momentum with volume rising up to over 10 million as we write this. MTP rallied in the premarket and kicked off the trading at $2.49 before its previous close of $2. As of 11:14 A.M. EDT, MTP was trading at $2.35 rallying up 17.53%.
Midatech is a biotechnology company focused on the R&D segment improving the biodistribution and bio-delivery of medicines. The company today reported that it obtained encouraging Phase 1 results of MTX110, a medicine being developed for patients’ sufferings from DIPG.
The Phase 1 study was conducted at the University of California, San Francisco. The primary endpoint of the Phase 1 study was to determine the prescribed dosage that would be used in the upcoming Phase 2 study of MTX110 safety and efficacy among DIPG patients.
The initial endpoint data from the UCSF study shows dosage support of MTX110 in range of 60μM and 90μM, depending on tolerance level of the patient based on 12 infusions during Phase 2.
The principal investigator of the UCSF study, Sabine Mueller commented that the study has opened the way for the next phase. He said:
“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.”
During Phase 1 of the study seven patients were appointed and they were newly treated with DIPG attaining focal external beam radiation therapy for a time span of 4 to 14 weeks before they were dosed MTX110.
By using convection-enhanced delivery (CED) through a micro-catheter, MTX110 was administered directly into the tumor with gadolinium-enhanced intra-operative MRI to guide and record drug distribution to the tumor.
Diffuse Intrinsic Pontine Glioma is horrible pediatric brain cancer and at the moment there are very little treatment options with a low rate of effectiveness. The company is looking forward to keeping up the testing of MTX110 to establish whether it can make a difference to DIPG patients and their families.
Midatech Pharma reported that three patients remain alive and are under continuous monitoring. The primary endpoint did not include survival, so no such conclusions have an impact of MTX110 on the overall survival rates that can be extracted from these data.
The company plans to evaluate the overall survival at a 12-months period during the Phase 2 trials which will be the primary endpoint of the study during that phase in 19 patients.
Midatech Pharma Plc (MTP) expects MTX110 to be delivered via an alternative CED catheter system that allows direct regular drug infusions into the tumor without any need of second surgery.