HORSHOLM, Denmark, May 31, 2012 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that a subgroup analysis of African-American stable kidney transplant patients enrolled in Study 3001, a Phase 3 non-inferiority study, suggests that these patients may be safely converted from twice-daily Prograf® to once-daily LCP-Tacro. In addition, there was a trend toward fewer biopsy-proven acute rejections (BPARs) with LCP-Tacro compared to Prograf. The analysis will be presented at the American Transplant Congress, June 2 to 6, in Boston. Three additional presentations will discuss the activity and tolerability of LCP-Tacro in kidney and liver transplant patients.
"Results from the total patient population in the 3001 Phase 3 trial in stable kidney transplant patients indicate that LCP-Tacro met its primary safety and efficacy endpoints compared to Prograf and LCP-Tacro demonstrated a trend toward lower rejection rates, based on a blinded central pathology reading," said William Polvino, M.D., president and chief executive officer of Veloxis Pharmaceuticals. "African-Americans are an important subgroup that historically experience inferior clinical outcomes post transplant. This subgroup analysis suggests that African Americans experience similar clinical results on LCP-Tacro, once-daily, as with twice-daily tacrolimus and there is evidence to suggest a lower acute rejection rate. We are now looking forward to reviewing the results of the second Phase 3 trial in de novo kidney transplants, including African Americans, in the second quarter of 2013."
West-Thielke et al. (Abst. #1289; poster 156, 5:30 6:30 p.m. EDT, June 4) analyzed the African-American sub-population from a Phase 3 study in stable transplant patients who were randomized to either continued twice-daily tacrolimus (n=34) or converted to once-daily LCP-Tacro (n=35).The initial dose of LCP-Tacro was 15 percent lower than the pre-conversion Prograf dose.
Graft and patient survival, over the 12 month study, were 100 percent for both patient groups. BPAR, via blinded centralized readings, was none for LCP-Tacro and 9 percent for Prograf (p=0.1142). Reports of adverse events were similar in the two groups. These data suggest that LCP-Tacro is a promising drug candidate in this difficult-to-treat patient group.
The company, and its collaborators, will present three other abstracts that provide additional detail on the pharmacokinetic (PK), safety and efficacy profiles of LCP-Tacro.
Tacrolimus is a drug that must be kept in a relatively narrow range of blood concentrations. Blood levels that are too low can result in rejection of the organ. Blood levels that are too high can cause a number of side effects including tremor and kidney toxicity. Abst. #1295 (poster 162, 5:30 6:30 p.m. EDT, June 4) suggests a significant reduction in stable kidney patients of tacrolimus peak concentrations, or Cmax, with LCP-Tacro compared to twice-daily tacrolimus while maintaining comparable minimum blood levels. In addition, fewer patients on LCP-Tacro (15 percent) reached high Cmax levels of greater than 20 ng/mL than with twice daily tacrolimus (38 percent). Although clinical monitoring for trough levels is standard of care, Cmax is not routinely followed in clinical practice. Given these findings, Veloxis will continue to explore options to assess the impact of peak levels on long-term safety and efficacy.
Two other presentations will provide additional information on the performance of LCP-Tacro in liver transplant patients.
Feng et al. (Abst. #709, poster 177, 5:30 to 7 p.m. EDT, June 2) will present data on a Phase 2 study comparing the PK, safety and efficacy of LCP-Tacro compared to twice-daily Prograf in de novo liver transplant patients at days one, seven and 14 post transplant. LCP-Tacro showed similar PK, safety and efficacy compared to Prograf over the 14 days of the trial.
Washburn et al. (Abst. #715; poster 183, 5:30 to 7 p.m. EDT, June 2) will report on 26-week data from a Phase 2 open-label, 50-week extension of a 14-day clinical trial investigating the PK stability of LCP-Tacro compared to twice-daily tacrolimus in liver transplant patients. The investigators found that the 26-week data closely resembled the 14-day LCP-Tacro data in regards to daily dose, area under the curve and peak systemic exposure, among other parameters. This study showed that LCP-Tacro, administered once-daily in stable liver transplant patients, resulted in consistent PK performance for up to 26 weeks.
These results add additional evidence that LCP-Tacro once-daily tablets may prove to be an alternative to Prograf twice-daily and that LCP-Tacro can be given at approximately 20 percent lower doses while maintaining the same overall exposure and trough levels.
For more information, please contact:
John Weinberg, M.D., Chief Commercial officer
Phone: +1 732 321 3208
For further information, please visit www.veloxis.com.
About LCPTacro and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCPTacro is an investigational drug that it is being developed as a oncedaily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peaktotrough variability when compared to currently approved tacrolimus products. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity, tremor, diabetes, high blood pressure, and opportunistic infections. Therefore, tacrolimus levels need to be managed carefully, and transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments after receiving a new organ.
About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company's lead product candidate is LCPTacro for immunosuppression, specifically organ transplantation. Veloxis' unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability at lowscale up costs. Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market that is commercialized through partner Santarus, Inc.. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.
SOURCE Veloxis Pharmaceuticals A/S