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Veloxis Pharmaceuticals Presents LCP-Tacro™ Phase 3 Data at the American ...
/PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today will present detailed blinded central pathology (biopsy) results from the LCP-Tacro™ study 3001 a long-term safety and efficacy switch study of LCP-Tacro™ in kidney transplant recipients, at the American Society of Nephrology (ASN) Kidney Week Annual Scientific Meeting.  Topline results of this study were released in June 2011. The results presented today show that LCP-Tacro™ once-daily was associated with a trend towards reduction in the incidence of Biopsy Proven Acute Rejection (BPAR) and a tendency for less severe histological changes compared to Prograf® twice-daily.

LCP-Tacro™ Data Presented

35 needle biopsies (23 LCP-Tacro™, 12 Prograf®) were centrally read by one pathologist blinded to treatment assignment. 1 BPAR episode was recorded for 1 LCP-Tacro™ patient, vs. 7 BPAR episodes in 5 Prograf® patients (5 unique Prograf® patients with 1 BPAR each; 2 patients had 2 episodes each) (p=0.21). All BPARs were mild; however, BANFF chronicity score tended to be greater in the Prograf® group (LCP-Tacro™ = 2, n=1; Prograf® mean = 3.6, n=5). Overall, 1 of 162 patients randomized to receive LCP-Tacro™ therapy (0.62%) and 5/162 patients randomized to receive Prograf® treatment (3.1%) in the modified intent-to-treat population had greater than or equal to 1 centrally read BPAR (p=0.215).