Ark Therapeutics Group has announced that it is ready to progress to Phase I trials for EG013, a innovative treatment for severe foetal growth restriction (FGR), a terminal condition for which there is no effective treatment.
The decision to move ahead with EG013, an adenovirally mediated VEGF-based product, was based on positive feedback from the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA concluded that the choice of species and overall design of the toxicology programme, including a series of in vitro studies using human placenta, are suitable to support a Phase I study.
Results from the first two preclinical trials of EG013 showed that a single treatment with EG013, directly into the mother's uterine artery, increased bloodflow to the placenta by 25%, and that the effect was maintained for 50 days.
Ark director of research and development Dr David Eckland said that EG013 has already shown early signs of promise for foetal growth restriction, which is a very distressing condition.
"The MHRA's support is further validation of our gene-based medicine technology and expertise and we look forward to progressing with our collaborators," Eckland said.
Severe foetal growth restriction is an often-terminal condition usually first diagnosed around 20 weeks into pregnancy, in which insufficient blood supply to the placenta results in serious growth retardation, leading to premature death, undesired termination or long-term neurological problems in surviving infants.