Aimspro (hyperimmune goat serum product) / Daval International - LARVOL DELTA

Treatment of diffuse systemic sclerosis with hyperimmune caprine serum (AIMSPRO): a phase II double-blind placebo-controlled trial (Ann Rheum Dis) - P2, N=20; PMID: 24067785; NCT00769028; Sponsor: Daval International Limited; "Mean modified Rodnan Skin Score (mRSS) fell by 1.4±4.7 units with active treatment but increased by 2.1±6.4 units on placebo when baseline values were compared with 26 weeks and responder analysis showed clinically meaningful improvement in mRSS at 26 weeks in 5 (50%) of actively treated patients compared with 1 (10%) in the control group (p=0.062). PIIINP (µg/L) showed a comparatively larger increase in the treatment group compared with the placebo group, (p=0.0118)."

P2 data • Fibrosis

Multiplex serum protein analysis in systemic sclerosis defines potential anti-fibrotic mechanisms and markers of response to hyperimmune caprine serum (ACR-ARHP 2015) - Presentation time: Wednesday, November 11, 2015, 11:00AM-12:30PM; Abstract #3264; P2, N=20; NCT00769028; Sponsor: Daval International Limited; "Consistent with previous preclinical studies there was evidence for marked upregulation of the hypothalmo-pituitary-adrenal axis from 6 weeks after HCS treatment and this effect was maintained at 26 weeks. This was evidenced by increase in alpha-MSH and ACTH in cases treated with HICS. There were changes in markers of fibroblast biology including changes in bFGF, PIIINP and COMP....Other factors that were frequently reduced, though not reaching statistical significance, included TIMP2, fractalkine and TGFbeta1 levels."

P2 data • Fibrosis • Systemic Sclerosis