Our Research and Development department conducts a number of clinical studies in our therapeutic areas of interest in collaboration with hospitals, universities and research centres in Italy and across the world.
Within the scope of these studies, our attention to patients goes well beyond trials. We make our experimental drugs available for specific projects and - in compliance with international regulations - also provide a ‘compassionate’ access program, where drugs still in clinical trial are available for patients before they are fully registered by the competent authorities.
Following this, we share the results with the scientific community and relevant authorities and the data from our studies can be accessed on a number of public databases, including www.clinicaltrials.gov.
Our clinical studies are conducted in full compliance with Good Clinical Practice (GCP) international guidelines.
The study demonstrated the safety and efficacy of two dose regimens of the recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle, for inducing a complete healing of stage 2 (persistent epithelial defect) and stage 3 (corneal ulcer) neurotrophic keratitis.
The study evaluated the efficacy of a 20 µg/ml six times a day administration of rhNGF eye drops solution (a formulation containing anti-oxidant) compared to vehicle (formulation containing anti-oxidant) administered six times a day.
REP0114 Study (fRida)
Reparixin oral tablets were tested as a CSC targeting agent in patients with metastatic non-human epidermal growth factor (HER2)-amplified BC receptor.
DIABETOLOGY AND TRANSPLANTATION
The study investigated whether ladarixin had sufficient activity (preservation of β-cell function and slow-down of the progression of T1D) to warrant its further development (proof of concept trial). The safety of ladarixin in the specific clinical setting was also evaluated.
The phase II/III, multicentre, double-blind, parallel assignment study, involved 100 adult recipients of an intra-hepatic pancreatic Islet Auto-Transplantation (IAT).
Chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after organ transplantation. Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development.