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Phase 2 Trial of Deltavasc Fails To Meet Primary Endpoint in Peripheral Arterial Disease
BURLINGAME, Calif., Sept. 29 /PRNewswire-FirstCall/ -- Valentis, Inc. announced today that its Deltavasc™ product did not meet its primary endpoint in a Phase II clinical trial in patients with the intermittent claudication form of peripheral arterial disease. The primary efficacy endpoint in the study was improvement in exercise tolerance after 90 days with the Deltavasc™ product versus control. Patients in the Phase II clinical trial were randomized equally to receive either Deltavasc™ (Del-1 gene plus PINC™ polymer) or PINC™ polymer alone, which acted as the control agent in the clinical study.
Data from the trial indicate that both treatment arms were, in fact, active. There was a statistically significant increase in exercise tolerance from baseline in both the Deltavasc™ (Del-1 gene plus PINC™ polymer) and PINC™ polymer treatment groups. Importantly, there was also a statistically significant improvement in ankle brachial index (ABI), a clinical indicator of blood flow, in both the Deltavasc™ and PINC™ polymer treatment groups. The improvement in exercise tolerance in both groups was virtually identical and well above the 14% or less placebo effect observed in previous trials of similar design. The finding of statistically significant improvement in ABI concomitant with improvements in exercise tolerance is supportive of the exercise results and it points to a hemodynamic mechanism for the therapeutic effect of the PINC™ polymer. Importantly, there was also a statistically significant correlation between improvement in peak walking time and improvement in ankle brachial index.
At the 90-day assessment, the PINC™ polymer group of 51 patients had a significant increase in exercise tolerance from baseline of 34% (p
Benjamin F. McGraw, III, Pharm.D. Chairman, President and CEO stated, "While we were surprised with the lack of difference in the two treatment groups in this trial, we believe there is sufficient evidence from our Phase II trial to warrant a pivotal trial of PINC™ polymer in peripheral arterial disease. If PINC™ polymer demonstrates similar efficacy and safety in subsequent clinical trials, we intend to bring to market a product that is safer with more convenient dosing and potentially better efficacy than currently available products for peripheral arterial disease. We also plan to initiate a trial of Deltavasc™ in a non-cardiovascular indication. Based on the preclinical studies completed to date, Del-1 is clearly an angiogenic agent. We will continue to evaluate opportunities for this product in cardiovascular indications."
Phase II Trial Design
This was a randomized, double-blind, placebo-controlled trial of 100 patients at 17 centers in the US. The primary endpoint was change in exercise tolerance at 90 days in patients receiving Deltavasc™ versus those receiving PINC™ polymer. Patients were randomized equally to receive either 84 mg of Deltavasc™, which is a formulation of a 5% solution of PINC™ polymer mixed with the Del-1 gene, or a 5% solution of the PINC™ polymer alone. The PINC™ polymer was mixed with the Del-1 gene because PINC™ polymer is believed to be active on cell membranes, which increases the uptake of the gene. This PINC™ polymer is a non-ionic polyoxyethylene-polyoxypropylene block copolymer, which has the chemical characteristics of components of cell membranes. Patients eligible for entry into the trial had evidence of active intermittent claudication at baseline.