Midatech Pharma has prepared its candidate MTD119 (previously MTR104) for advanced liver cancer for the clinical testings, in a pre-clinical programme that included three subcutaneous or orthotopic liver cancer xenograft models treated with the active cytotoxic compound maytansine conjugated with Midatech’s gold nanoparticle (GNP) technology.
According to Midatech, the studies showed 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, Midatech said.
$1.5 billion of Sorafenib sales projected for 2018
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 billion.
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.
Dr Jim Phillips, CEO of Midatech, said that this is an important milestone in moving the MTD119 compound towards the clinic represents Midatech’s first anti-cancer product using the company’s core proprietary GNP technology platform. Philips said he was very encouraged by the results so far and that the company will stay focused on completing the formal IND safety studies over the next six months to get the product ready for first in human studies in 2018.