Midatech Pharma Plc (LON:MTPH, NASDAQ:MTP) saw its shares gain 9.5% after the firm said it had passed an important regulatory milestone after confirming it had received orphan drug designation for its liver cancer treatment from the European Medicines Agency.
The classification, which exists to get breakthrough therapies to areas of unmet medical need, brings with it certain financial and developmental support, as well as 10-years marketing exclusivity.
READ: Midatech Pharma trading in line with forecasts with focus turning to clinical trials
Midatech’s MTD119 is a combination of the company’s gold nanoparticle technology and the drug maytansine. It is being developed to tackle in a targeted way hepatocellular carcinoma, a rare, aggressive cancer that affects the liver and which has a poor prognosis.
A recent pre-clinical study suggested MD119 may be more efficacious than sorafenib, the current standard of care.
First-in-human trials
First-in-human trials of the Midatech breakthrough are expected to get underway late this year or early next. First, researchers will assess the toxicology of the drug before lodging an investigational new drug application.
The global market for products treating hepatocellular carcinoma is expected to be in the order of US$1bn by 2024, according to Midatech.
“However, due to the limited efficacy and high toxicity of existing treatments, we believe there is scope to significantly expand this market,” it added.
Chief executive, Dr Jim Phillips, said the focus was now on developing MDT119 as quickly as possible, while continuing work on its pipeline of other oncology treatments.
In late afternoon trading, Midatech shares were 9.5% higher at 34,5p.
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