The first-in-human Phase 1 clinical trial of Avilex Pharma’s lead candidate AVLX-144 was conducted successfully in collaboration with Clinical Research Services Turku (CRST) in Finland. During the course of the Phase I study, AVLX-144 was well-tolerated and demonstrated no noteworthy safety issues. The result provided a solid foundation for Avilex’s transition into later phase clinical trials, thus Avilex Pharma and Simcere Pharmaceutical Group Ltd later announced that they had entered into a strategic partnership to develop and commercialize AVLX144 in Greater China.
Mikael Thomsen MSc, PhD. I have over 25 years of experience from the pharma and biotech industry – primaly covering the early development phase and translational medicine. I have executed numerous Phase I and Phase IIa/cPoC studies in several indication areas. I am involved in several biotech companies both as co-founder but also as consultant.
I met CRST’s Ville Ranta-Panula at a conference in Copenhagen and was surprised about their capabilities in clinical research, especially about the wide -ranging imaging capabilities that they have in Turku, by collaborating with Turku PET Centre. Soon after that, I was looking for a Phase 1 unit for our company’s First-in-human-trial. CRST provided a really good proposal and I wanted to meet the rest of the team. I spoke with their experts which made me feel that my project would be in good hands with them.
Yes, I would recommend CRST. The collaboration between all parties went very positive. CRST conducted the Phase I, SAD (First in Man) very professionally and diligent – and even under severe COVID-19 periods. The CRST team performed excellent from CTA preparation start, study conduct and management as well as in the reporting phase.
Avilex Pharma is a Danish clinical stage biotechnology company developing innovative treatments for acute neurological conditions such as acute ischemic stroke (AIS) and subarachnoid haemorrhage (SAH). Their clinical lead candidate – AVLX-144 – is a dimeric peptide-like drug candidate for the treatment of acute ischemic stroke, which targets the intracellular scaffolding protein, postsynaptic density protein 95 (PSD-95).