Peripheral Vascular Disease

February 13, 2012

Merck released results from a clinical trial of vorapaxar, under development for the prevention of thrombosis and the reduction of cardiovascular events. TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) was a secondary prevention study in 26,449 subjects with a heart attack, an ischemic stroke, or documented peripheral vascular disease. The subjects received vorapaxar plus standard of care or standard of care alone. The addition of vorapaxar to standard of care significantly reduced the risk of the primary endpoint of the composite of cardiovascular death, heart attack, stroke or urgent coronary revascularization compared to standard of care. There was a significant increase in bleeding, including intracranial hemorrhage, among subjects taking vorapaxar in addition to standard of care.

June 6, 2011

Aastrom Biosciences issued results from a phase IIb trial of ixmyelocel-T, their bone marrow-derived cellular therapy for damaged tissue in a lower extremity caused by critical limb ischemia (CLI). This double-blind, placebo-controlled trial, RESTORE-CLI, enrolled 86 subjects with a diagnosis of CLI and no previous major amputations. The subjects received intramuscular injections of ixmyelocel-T or an electrolyte solution into the affected limb and were followed for 12 months after treatment. The primary endpoint was time to first occurrence of treatment failure, measured by the following components: major amputation of the treated leg, all-cause mortality, doubling of wound size from baseline, and de novo gangrene. The trial met its primary safety and efficacy endpoints, demonstrating a statistically significant improvement in the primary endpoint at 12 months.

February 27, 2006

deCode genetics reported positive top-line results of their phase I clinical program for DG041, for the treatment of peripheral artery disease (PAD). A total of 196 healthy volunteers had received the drug to date, at doses up to 1600 mg, with no serious adverse events reported. The drug was seen to dose-dependently inhibit platelet aggregation following stimulation with collagen and sulprostone (a prostaglandin E2 agonist); maximum efficacious dose was reached. No significant changes were noted in platelet-function assay results or bleeding time. Based on these results, the company announced plans to initiate phase II trials of the drug in the near future.

August 23, 2004

Endovasc has announced positive results of their phase II study of Liprostin, their liposome-encapsulated formulation of prostaglandin E-1 (PGE-1), for the treatment of peripheral vascular disease (PVD). Results showed that the study met both its primary endpoints, with participants experiencing a greater-than-100% improvement in mean walking distance and a just-under-200% improvement in pain-free maximum walking distance. In addition, participants reported significant improvements in day to day quality of life, as measured on the PADWIQ standardized questionnaire. The three month study treated 73 subjects with PVD. Endovasc is currently reviewing strategies for the next steps in Liprostin’s development.

June 21, 2004

Endovasc reported preliminary results from a phase II trial investigating Liprostin, a liposome-encapsulated form of prostaglandin E-1 (PGE-1) for the treatment of peripheral vascular disease (PVD). Results showed that the first 28 subjects to complete the trial showed a marked improvement in both Maximum Walking Distance and Pain Free Maximum Walking Distance compared to baseline. Data demonstrated that the subject’s average MWD increased 80% from baseline, from 301 meters to 543 meters. Subject’s PFMWD increased 190%, from 85 meters to 246 meters. The study’s efficacy endpoints included Maximum Walking Distance (MWD) and Pain Free Maximum Walking Distance (PFMWD) compared to baseline. Liprostin has shown benefits in the treatment of heart attacks, occlusive disease, ischemic ulcers, critical limb salvage, claudicants, and arthritis.

December 8, 2003

Esperion Therapeutics reported positive results from a phase I trial investigating ETC-1001, a lipid-regulating agent for the treatment of hyperlipidemia. Results showed that the therapy was safe and well tolerated among all subjects. No serious adverse events occurred. The double-blind, placebo-controlled study enrolled 36 healthy subjects and was designed to determine the safety and tolerability of escalating doses of ETC-1001. Subjects took single doses of ETC-1001 over a range of dose levels and were monitored for 72 hours. ETC-1001 was also shown to inhibit the progression of atherosclerosis in pre-clinical studies.

September 15, 2003

AstraZeneca reported positive results from a trial investigating Atacand, an approved angiotensin receptor blocker for the new indication of chronic heart failure. Results demonstrated that Atacand reduced cardiovascular deaths or hospital admissions for heart failure by 16% when compared to placebo. The international, multi-center program, called CHARM (Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity) enrolled 7,601 subjects with symptoms of chronic heart failure. The program consisted of three independent, parallel, double blind, placebo-controlled trials. Treatment with Atacand was generally well tolerated but associated with a greater occurrence of discontinuation of study medication compared to placebo due to an increase in serum creatinine (6.2% vs. 3.0%) hypotension (3.5% vs. 1.7%), and hyperkalemia. Atacand is currently approved for the treatment of hypertension. Results were published in the September 6th edition of The Lancet.

NicOx reported positive results from a phase II endoscopy trial investigating NCX 4016, a nitric oxide for the treatment of peripheral arterial obstructive disease (PAOD). Data demonstrated that gastric safety, measured by endoscopy, was significantly better for NCX 4016 both as a monotherapy and in combination with aspirin compared to treatment with aspirin alone. Results also showed that NCX 4016 showed greater activity in the inhibition of inflammatory markers compared to aspirin. Endoscopic scores for NCX 4016 were similar to placebo. The study enrolled 48 subjects who were treated for 21 days. Results were reported in November 2003 at the American Heart Association meeting in Orlando.