Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the international specialty pharmaceutical company focused on developing and commercialising products in oncology, today announces the successful completion of its pre-clinical programme for its wholly-owned candidate MTD119 (previously MTR104) for advanced liver cancer.
The pre-clinical programme included three subcutaneous or orthotopic liver cancer xenograft models treated with the active cytotoxic compound maytansine conjugated with Midatech’s gold nanoparticle (GNP) technology.
The studies demonstrated potent anti-tumour activity in vivo in all efficacy models. Peak reduction in tumour growth due to MTD119 was more than six-fold (mean reduction more than three-fold) compared to the current standard of care, sorafenib, and with improved overall survival. The specific targeting of maytansine to tumour cells by MTD119 also resulted in significantly improved tolerability.
MTD119 is a targeted therapy treatment for advanced hepatocellular carcinoma, which accounts for most liver cancers and is the third leading cause of cancer deaths worldwide with almost 800,000 deaths in 20151. Currently, 95% of cases are non-curable and non-operable and median survival is less than one year, with rare and short-lived successful outcomes with existing forms of chemotherapy. Sorafenib (Nexavar) has projected 2018 annual sales of almost $1.5 billion2.
MTD119 will now enter formal investigational new drug (IND) application enabling studies, with completion expected in H1 2018. This will be followed by an expected IND submission to the US Food and Drug Administration for first in human studies to commence in 2018.
Commenting on the pre-clinical results, Dr Jim Phillips, CEO of Midatech, said: "This is an important milestone in moving our MTD119 compound towards the clinic as it represents Midatech’s first anti-cancer product using the Company’s core proprietary GNP technology platform. We are very encouraged by the results so far and are focused on completing the formal IND safety studies over the next six months and getting the product into first in human studies in 2018.”
1 World Health Organization cancer fact sheet, February 2017, www.who.int/mediacentre/factsheets/fs297/en