StockMarketWire.com - Clinical stage drug development company Evgen Pharma said it had made progress in discussions with the UK and US health regulators for two clinical trials set to commence in 2022.

The first trial was a phase I human volunteer study to investigate the safety and pharmacodynamic properties of the company's new SFX-01 tablet formulation.

Evgen held a scientific advice meeting with the MHRA in December 2021, and an application to approve the trial was expected in late January.

In the US, meanwhile, Evgen's application for a pre-investigational new drug application meeting to the FDA had now been granted, with a written responses to a meeting package expected to be submitted to FDA in January.

The new drug application would relate to a phase Ib/II trial of SFX-01 in glioblastoma that was planned to commence in 2022.


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