In June 2006, we announced final results from the Phase 2 multi-center study entitled: "A randomized, double-blind, placebo-controlled, dose ranging study of the effects of Zerenex on serum phosphate in patients with end stage renal disease (ESRD)." This Phase 2 study was conducted under an IND sponsored by our licensors in both the United States and Taiwan.

From this Phase 2 study, the investigators concluded that Zerenex appeared to have an acceptable safety and tolerability profile at the 2, 4, and 6g/day dose. The optimum dose of Zerenex in this study was 6g/day at which it appeared to be efficacious, safe and well tolerated as treatment for hyperphosphatemia in hemodialysis patients. Additionally, the investigators found that Zerenex therapy for up to 28 days had no statistically significant effect on serum iron, ferritin, transferrin saturation, or total iron binding capacity.

In December 2008, we completed our Phase 2 high-dose tolerance and safety study. The goal of this study was to assess tolerability and safety in end-stage renal disease patients with doses of Zerenex ranging from approximately 3.0 grams per day to 12.0 grams per day. The open-label study was conducted in two parts by the Collaborative Study Group utilizing seven sites in the U.S. Part 1 of the study enrolled 34 patients. Patients taking approximately 6 to 15 capsules or tablets per day of their current phosphate binder were immediately switched to a starting dose of 4.5 grams per day of Zerenex, and were treated for 28 days. Part 2 of the study enrolled 21 patients. In this part, patients taking approximately 12 or more capsules or tablets per day of their current phosphate binder were immediately switched to a starting dose of 6.0 grams per day of Zerenex, and were treated for 28 days. In January 2009, we presented preliminary results of part 1 of the study at the J.P. Morgan Annual Healthcare Conference. In March 2009, we provided updated preliminary results for the entire study on our fourth quarter and year-end financial results conference call. The preliminary results for the entire study are found in the table below.

		Serum Phosphorous (Mean +/- standard deviation)
Visit 0 (Baseline)		5.8 +/- 1.5
Visit 4 (Treatment for 28 days)		5.4 +/- 1.3

The average dose of Zerenex administered in this trial was 7.5 grams per day. There were no observed changes in the following iron parameters: serum iron, ferritin, transferrin, and total iron binding capacity, or intact parathyroid hormone. Four serious adverse events were reported, all of which were deemed by the investigators to be unrelated to Zerenex. The most commonly reported adverse event was change in stool color, which is an expected side effect of Zerenex, about which all of the patients were notified in advance, and no patients withdrew from the study as a result. In addition, although not designed as an efficacy clinical trial, Zerenex appeared to manage and control serum phosphorus levels in patients who were switched from their current phosphorus binders without washout to Zerenex.