Midatech Pharma (AIM: MTPH), a research and development-focused biotech company, has published “Encouraging Headline Results” from a Phase I study of MTX110 drugs used to treat patients with rare diffuse intra-initiated ponsorb glioma brain tumors.
DIPG is a primary brain tumor that develops in the middle of the brainstem and cannot be surgically removed. This particular tumor occurs primarily in children, with median survival rates within 10 months of a cohort of 316 cases, with only 35% surviving up to 12 months.
Although radiation therapy prolongs survival, the majority of patients die within one year of diagnosis, and systemic chemotherapy has proven ineffective for around 1,000 individuals diagnosed with aggressive DIPG each year.
Luckily, treatment for Midatech Pharma and MTX110 appears to be moving towards tackling DIPG. Positive data have been recorded in the Phase I exam at the University of California.
The function of this phase of the study was to determine the appropriate dosage regimen for phase II, as seven patients were receiving local external radiation prior to receiving MTX110 treatment. Once the trial began, each patient received up to 12 cycles of treatment every 4-8 weeks using convection-enhanced delivery to guide and track drug distribution into the tumor using gadolinium-enhanced intraoperative MRI.
Throughout the cycle, dosages were escalated between and within patients depending on resistance, with infusion doses increasing from a concentration of 30 μm, followed by 60 μm and 90 μm as the sixth and seventh dose increments, respectively.
However, while showing appropriate doses for Phase II, the Phase I trial data appeared to suggest the potential efficacy of MTX110 treatment. At the interim cutoff date, the median overall survival based on Kaplan-Meier analysis was 26.06 months, with the number of patients doubled over 12 months, survival to 71.4%.
Midatech Pharma said five of the seven patients survived for 12 months, and three of the original seven remained alive and remained under surveillance.
The company noted that survival is not the endpoint of the initial study and therefore cannot draw conclusive conclusions from the data. That is the arrival of Phase II, with 19 patients being assessed for overall survival at 12 months. The next step is to directly compare historical survival data with patient data. Here, it is expected that MTX110 will be delivered using an alternative convection-intensive delivery catheter system that allows for routine drug injections directly to the tumor without the need for repeated surgery.
Sabine Mueller MD PhD, principal investigator at UCSF Research, said: “This study determines the proposed dose range for phase II MTX110 and shows that repeated delivery of MTX110 via CED is feasible and safe. We will evaluate the effectiveness of future phase II studies in this patient population.”
Steve Damment, EVP R&D at Midatech, added: Although overall survival data from this Phase I study are encouraging, further studies of DIPG MTX110 are needed to establish whether these patients and their families can make a difference. ”
Following MTX110’s uplifting phase I, MidAtech Pharma shares were 24.39% or 8.05p, reaching 41.05pa shares at 13:00 GMT on 19/10/20.
