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Renal Artery Disease

June 10, 2013

Keryx Biopharmaceuticals reported results from a phase III trial of Zerenex for the treatment of elevated serum phosphorus levels in patients with end-stage renal disease (ESRD) on dialysis. This multicenter, randomized, open-label, safety and efficacy clinical trial enrolled 441 ESRD patients on hemodialysis or peritoneal dialysis. Zerenex was administered using a 1-gram oral caplet formulation. The study consisted of a two-week washout period followed by a 52-week Safety Assessment Period in which subjects were randomized 2:1 to receive either Zerenex or an active control (Renvela and/or Phoslo). The 52-week SAP was followed by a four-week Efficacy Assessment Period (EAP). Zerenex met the primary endpoint of effectively controlling serum phosphorus in the EAP. Safety results yielded a positive overall profile and results were well tolerated. The most frequent adverse events were infections and infestations, vascular disorders, gastrointestinal disorders and cardiac disorders.

November 17, 2008

Pervasis issued positive pooled results from phase I and II trials of Vascugel, an allogeneic cell therapy for the repair and regeneration of vasculature pathways. These studies, collectively dubbed V-HEALTH (Vascular intimal Hyperplasia: Extending Arterial and venous patency, Limiting vascular Trauma, and inhibiting Hyperplasia while re-establishing vascular health), enrolled a total of 65 subjects with end-stage renal disease undergoing placement of an arteriovenous (AV) graft or AV fistula for hemodialysis access. The phase I trial was a non-randomized, open-label study in four subjects receiving AV fistulae and four subjects receiving AV grafts. The phase II trial was a multi-center, double-blind study of Vascugel versus placebo in 57 subjects, 27 receiving an AV fistula and 30 receiving an AV graft. The primary endpoint was the incidence of local wound infection, intervention (surgical, endovascular or percutaneous) and acute thrombosis within 30 days post-surgery. Treatment with Vascugel led to a lower incidence of each endpoint compared to placebo: 6.5% and 10.9% for the Vascugel treated arms at two and four weeks, respectively, versus 21.1% and 21.1% for the control group. In the AV graft intent-to-treat population (n=61), treatment with Vascugel showed a statistically significant decrease in the incidence of early complications compared to placebo ((5.3% versus 10.5%; p=0.047) at two weeks; this trend continued at four weeks. Treatment was well tolerated and there was no difference in serious adverse events between Vascugel and placebo groups.

April 18, 2005

Celgene reported positive interim results of a pair of parallel phase III trials of Revlimid (lenalidomide), for the treatment of multiple myeloma. Trial data have yielded strong evidence of superiority, with a median time to progression of at least 15 months for the US study and more than 11 months for the international study, vs. only 5 months for subjects receiving dexamethasone alone. This superiority was highly statistically significant (p<0.00001), and the duration and number of ongoing responses mean that the primary endpoint, which was to characterize the overall time to progression, cannot yet be calculated. Clinical responses were observed in 51.3% and 47.5% (respectively by trial) of subjects receiving combination therapy with the drug, vs. 22.9% and 18.4% of subjects receiving dexamethasone monotherapy (p=0.001). Both studies were randomized, double-blinded, placebo-controlled trials which enrolled relapsed or refractory multiple myeloma patients; these patients were randomized 1:1 to receive Revlimid plus dexamethasone (combination therapy) or dexamethasone alone. One trial enrolled 354 subjects across 47 US sites, while the other enrolled 351 subjects across 50 international sites. These ongoing trials are being conducted under a Special Protocol Assessment with the FDA, and will form the basis of both NDA and MAA submissions.

CureTech issued results of a phase I trial of their investigational monoclonal antibody CT-011, for the treatment of hematological malignancies. Trial data yielded positive safety indications, with no significant adverse events noted and a positive overall toxicity profile: no dose-limiting toxicities were observed, the most common adverse events were mild allergic reaction and low grade fever, and single-administration maximum tolerated dose was not reached. Preliminary evidence of clinical response was also observed in 5 subjects, with 1 partial response (including platelet transfusion independence) through 8 months, 2 incidences of stable disease through at least 7 months, and 2 minimal responses. This open-label escalating dose study enrolled 17 subjects with advanced refractory hematological malignancies at the Chaim Sheba Medical Center in Tel-Hashomer, Israel. Subjects received a single 5-hour intravenous infusion of escalating doses of the drug, and were followed for safety, tolerability, and evidence of disease progression.

Lorus Therapeutics has reported preliminary results of a phase II study of GTI-2040, their investigational ribonucleotide reductase R2 inhibitor, for the treatment of renal cell carcinoma. Results from the study yielded evidence of efficacy, with 52% of subjects experiencing disease stabilization or better, including 1 patient with a 23% reduction in tumor burden and disease stabilization through 10 months and 1 partial response, a 39% reduction in tumor burden and disease stabilization through 8 months. This open-label study enrolled 33 patients with advanced metastatic renal cell carcinoma across 7 US sites, who received combination therapy with GTI-2040 and capecitabine, an approved chemotherapeutic. The trial was co-sponsored by the National Cancer Institute.