Documented PIF effects: regulate immunity, inflammation and transplant acceptance; Initiated studies in clinically-relevant preclinical models
Developed basic assays to detect PIF in viable embryo culture media and maternal blood; Confirmed PIF’s promoting effect on embryo, endometrium and trophoblast
Gained insight into PIF’s targeted mode of action
Published first-of-series of PIF studies supporting pro-pregnancy effects
Completed FDA-mandated comprehensive toxicology studies: PIF has high safety profile – no toxicity, no side effects observed
Published that PIF is effective in autoimmune and transplant models; Produced (cGMP) PIF human-grade, ready-to-inject for patients in a clinical setting
Awarded FDA Fast-Track Designation for PIF in Orphan Drug Disease therapy; Initiated diagnostic clinical trials for PIF in IVF and maternal blood (NCT01805102, NCT01803893, NCT02222831 and NCT02129998)
Obtained FDA and University IRB approval for FIH (first-in-human) PIF-based therapy; Initiated University-sponsored PIF clinical trial for an ongoing immune disorder
Launched FDA Fast-Track First-in-Human Phase 1 clinical trial to establish sPIF safety (NCT02239562)
Completed Phase 1 clinical trial establishing that sPIF has high safety profile and no toxicity.
Launched parallel Phase 2 trials to assess sPIF efficacy and dosing in humans.