Positive Plexival II Phase 1 Clinical Trial Results
The results from the PLEXOVAL II phase 1 human safety study highlights safety of off-the-shelf (allogeneic) Plexaris in healthy volunteers. There were no untoward or unexpected safety events reported during the study with all 11 enrolled participants remaining healthy throughout and after their 30-day follow-up period. These results further demonstrate a favourable safety profile of LEAP processing and of EVs from platelets. All induced wounds successfully healed without skin defects, abnormal scarring or abnormal cosmetic appearance. Due to the small numbers involved in the study there are no significant efficacy signals.
“These results confirm Exopharm as a leader in EV medicine manufacture and further validate our LEAP manufacturing technology. Forty clinical-grade doses of Plexaris were made within eight hours by two staff. If the study had been 100 times larger, it still would have taken the same amount of time and labour, only larger equipment. This is what we mean when we say LEAP is the only fully-scalable process for exosome purification that has been developed. This manufacturing capability is fully applicable to our engineered EV program, as this manufacturing process and the safety of product coming out of it is applicable to all EV medicines processed with LEAP,” said Dr Ian Dixon, Founder and Managing Director.