Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), the R&D company focused on delivering innovative oncology and rare disease products to patients, is pleased to announce an update on its key MTX110 programme.
MTX110 is designed for the treatment of childhood brain cancers such as Diffuse Intrinsic Pontine Glioma ("DIPG"), an ultra-rare highly aggressive and inoperable tumour located in the brain stem, that is universally fatal with an average life expectancy of 7 to 9 months. Midatech is also evaluating MXT110 for the treatment of Glioblastoma Multiforme ("GBM"), which is a fast-growing form of brain cancer in adults.
The initial MTX110 study (PNOCO15) in DIPG patients, began in May 2018 and is a combined Phase I (safety) and Phase II (efficacy) programme. Phase I is a dose escalating component originally designed with five dose levels; however, since MTX110 has been well tolerated in the patients treated to date, a further two higher dose levels have been added to the study. This Phase I component is scheduled to complete in Q3 2019.
Based on the Phase I progress to date, the Recommended Phase II Dose ("RP2D") has preliminary been set at the upper dosage level achieved in this Phase I component. A further small cohort of three patients will now be treated to complete the "3+3 design", the traditional standard dose escalation schedule in the development of cancer therapeutics, and to confirm this RP2D dose, bringing the total number of patients treated at the final RP2D to five. We expect these patients will join the Phase II efficacy component, which is scheduled to start during Q3/4 2019, following confirmation from the US Food and Drug Administration.
Dr Sabine Mueller, Principal Investigator for the study said: "Midatech's MTX110 has shown promise as one of the most potent compounds against DIPG brain tumour cells in laboratory experiments. In this first in human study of MTX110 we are encouraged by the excellent safety profile so far and look forward to completing the safety evaluation and commencing the efficacy assessment of the drug later this year."
Midatech's Chief Executive Officer, Dr Craig Cook, said: "We are delighted to be able to give this update on how the MTX110 programme is progressing. The patients have reacted very well from a safety perspective to MTX110 to date and we hope to advance to the Phase II component later this year and further evaluate MTX110 as a very promising therapy for DIPG, for which there are no effective treatments. We look forward to providing further updates as the development programme progresses."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For more information, please contact:
Midatech Pharma PLC
Dr Craig Cook, CEO
Tel: +44 (0)1235 888300
Panmure Gordon (UK) Limited (Nominated Adviser and Broker)
Freddy Crossley, Emma Earl (Corporate Finance)
James Stearns (Corporate Broking)
Tel: +44 (0)20 7886 2500
IFC Advisory Limited (Financial PR and UK Investor Relations)
Tim Metcalfe / Graham Herring / Heather Armstrong
Tel: +44 (0)20 3934 6630
Westwicke Partners (US Investor Relations)
Tel: +1 339 970 2843