Clinical Trials Resource Center

New Medical Therapies™

Coronary Artery Disease

September 30, 2013

The Medicines Company reported results of a phase III trial of intravenous (IV) antiplatelet cangrelor. The trial compared IV cangrelor to either oral clopidogrel or placebo for prevention of thrombotic (clotting) complications during and after percutaneous coronary intervention (PCI) in 25,000 patients. Evidence demonstrates that cangrelor significantly reduced the odds of the primary composite endpoint of death, myocardial infarction (MI), ischemia-driven revascularization (IDR) or stent thrombosis (ST) at 48 hours after randomization by 19% (3.8% for cangrelor v. 4.7% for control; or 0.81, 95% CI 0.71-0.91, p=0.0007) and stent thrombosis by 41% (0.5% v. 0.8%, or 0.59, 95% CI 0.43-0.80, p=0.0008). Angiographic complications during the procedure were significantly reduced by cangrelor with a marked reduction in new or suspected thrombus, in acute stent thrombosis and in the need for bailout glycoprotein IIb/IIIa inhibitor. The pooled analysis also showed the incidence of clinically important major bleeding as measured by GUSTO and TIMI bleeding scales was not increased with cangrelor. An FDA filing is in progress and filing plans in Europe are expected for Q4 2013.

May 7, 2012

AstraZeneca released results from a phase III comparative trial of Crestor and atorvastatin for the treatment of lipid parameters in acute coronary syndrome. This randomized, open-label, three-arm, parallel-group, multi-center study, LUNAR, enrolled 825 patients. Subjects received Crestor 20mg, 40mg or atorvastatin 80mg for 12 weeks. Results showed the mean change from baseline in LDL-C averaged over weeks six and 12 was significantly greater with Crestor 40mg (-46.8%; p<0.05) compared with atorvastatin 80mg (-42.7%), while Crestor 20mg (-42.0%) was similar to that of atorvastatin 80mg. Mean change from baseline in HDL-C averaged over weeks six and 12 showed HDL-C increased by a significantly greater extent with Crestor 20mg (+9.7%) and Crestor 40mg (+11.9%) than with atorvastatin 80mg (+5.6%), with both Crestor doses garnering p<0.01. Adverse events were similar in all arms, the most frequent being myalgia, angina pectoris, noncardiac chest pain and fatigue. AstraZeneca did not note further actions based on these results.

April 4, 2011

Pozen issued results from the phase I trial of PA32540, a tablet for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers. The randomized, open-label, two-arm crossover study, Co-Rx, was designed to compare PA32540 to current standard of care, Prilosec, both in conjunction with clopidogrel. Thirty healthy subjects were treated with one of the following: A) PA32540 in the morning plus clopidogrel (300 mg) over 10 hours later on day 1, and PA32540 in the morning plus clopidogrel (75 mg) 10 hours later on days two through seven; B) enteric-coated aspirin (81 mg) plus clopidogrel (300 mg) plus Prilosec (40 mg) all in the morning on day 1 followed by enteric-coated aspirin (81 mg) plus clopidogrel (75 mg) plus Prilosec (40 mg) all in the morning on days two through seven. Each treatment was separated by a 14 day washout period. The primary endpoint was the percent inhibition of platelet aggregation (IPA) after morning dosing on day seven of each period. The PA32540 treatment arm resulted in a significantly greater IPA than the standard of care arm, with an approximate 20% improvement in the anti-clotting effects.

November 22, 2010

Diffusion Pharmaceuticals issued positive results from a phase I/II trial of Trans Sodium Crocetinate (TSC) for the treatment of walking impairment due to peripheral artery disease (PAD). This randomized, double-blinded, placebo-controlled study enrolled 48 subjects with intermittent claudication symptoms from PAD. The subjects received TSC at doses of 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75 and 2.0 mg/kg or placebo. Study medication was dosed intravenously as a bolus injection once daily for five consecutive days. Data showed a notable dose response for peak walking time on a graded treadmill test at several TSC dosing levels after five days of treatment. There was a clinically meaningful improvement for the subjects who received 1.50 mg/kg of TSC of nearly three times the improvement observed with the placebo group. TSC was safe and well-tolerated at all doses.

May 18, 2009

Anthera released positive results from a phase II trial of varespladib for the treatment of acute coronary syndrome. This study, dubbed FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression), enrolled 625 subjects in North America and Europe. The subjects received varespladib 500mg or placebo administered within 96 hours of an Acute Coronary Syndrome (ACS) event, along with once daily doses of 80mg of Lipitor, for a minimum treatment duration of six months. Analysis of the primary endpoint, a reduction in Low Density Lipoprotein Cholesterol (LDL), was conducted when 500 subjects reached at least eight weeks of treatment after an ACS event. The primary endpoint was reached; a statistically significant reduction in LDL-C was observed at all prospectively defined time points as well as statistically significant reductions in total cholesterol and non-HDL cholesterol. A statistically significant greater proportion of subjects treated with varespladib achieved LDL-C levels of 70mg/dL or less (a target established by the American Treatment Program III for high-risk patients) and maintained this lower level throughout the primary endpoint. A key secondary endpoint, prevention of secondary Major Adverse Cardiovascular Events (MACE) was also reached.

March 3, 2008

Medicure reported negative results from a phase III trial of MC-1 for the treatment of coronary artery disease. This double-blind, randomized, placebo-controlled trial, dubbed MEND-CABG II, enrolled three thousand subjects undergoing coronary artery bypass graft surgery, at several cardiac surgical centers throughout North America and Europe. Subjects were randomized to receive placebo or MC-1 (250mg) prior to surgery and for thirty days post operatively (POD 30). They were then followed for sixty days after treatment (ninety days post operatively) for additional safety and efficacy analysis. The study failed to meet the primary endpoint, the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to POD 30. Based on the data, Medicure does not plan on filing for FDA approval of MC-1 for this indication.

January 21, 2008

Anthera released positive preliminary results from a phase IIb trial of A-002 for the treatment of cardiovascular disease. This multi-center, randomized, double-blind, placebo- controlled trial enrolled one hundred and forty subjects with stable coronary heart disease in the United States. The subjects received one of two different daily doses of A-002 or placebo, in addition to standard of care therapies, for up to eight weeks. The primary endpoint was reduction in secretory phospholipase A2 (sPLA2) levels. Secondary endpoints included a number of lipid and inflammatory biomarkers. Once-daily A-002 lowered sPLA2 levels and resulted in significant reductions in blood levels of total cholesterol, Non-High Density Lipoprotein Cholesterol (non HDL-C), and Low Density Lipoprotein Cholesterol (LDL-C), oxidized LDL, and apolipoprotein-B100 (Apo-B). Full results are expected later in 2008, with phase III trials to follow.

September 17, 2007

CV Therapeutics released positive results from a phase III trial of Ranexa for the treatment of Non-ST Elevation Acute Coronary Syndromes. This international, double-blind, randomized, placebo-controlled, parallel-group study was dubbed MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes). The trial enrolled 6,560 subjects who received intravenous Ranexa or placebo within 48 hours of the onset of angina due to ACS. This was followed by an out-patient treatment period with Ranexa extended-release tablets or placebo. All subjects received concurrent standard of care therapy. Results showed that the subjects receiving Ranexa had a 37% reduction in their relative risk of ventricular tachycardia lasting eight beats or more (p<0.001). In addition, there were fewer episodes of sudden cardiac death observed in the Ranexa group, with 56 deaths than in the placebo group, with 65 deaths. Based on positive phase III results, CV Therapeutics plans to file a sNDA with the FDA in the fall of 2007.

March 26, 2007

AtheroGenics reported negative preliminary results from a phase III trial of AGI-1067 for the treatment of acute coronary syndrome (ACS). This double-blind, placebo-controlled trial, dubbed ARISE, enrolled 6,100 subjects internationally. The trial failed to meet the composite primary efficacy endpoint of AGI-1067 compared to placebo on the time to first incidence of major adverse cardiovascular events (MACE). No difference was observed between the two groups. However other endpoints, including a reduction in the composite of "hard" atherosclerotic clinical endpoints, composed of cardiovascular death, myocardial infarction and stroke, as well as an improvement in several key diabetes parameters, were met. Based on the results AtheroGenics determined that further development of AGI-1067 is warranted. Full results are expected at the end of March 2007.

September 11, 2006

AstraZeneca announced results from a clinical trial, dubbed EXPLORER, of Crester (40 mg) and < for the treatment of elevated levels of C-reactive protein (CRP), a marker of inflammation and a risk factor for cardiovascular disease. Results demonstrated that 58% of the subjects on the combination therapy achieved dual LDL-C/CRP goals of LDL-C <100 mg/dL or <70 mg/dL and CRP <2 mg/L at six weeks, versus 24% on Crestor monotherapy. In addtion, the Cestor combination therapy: reduced CRP levels by 46% versus 29% with the monotherapy, reduced mean LDL-C by 70%, and allowed 94% of the subjects to achieve the NCEP ATP III LDL-C goal of <100 mg/dL versus 79% on monotherapy (p<0.001). Based on these results AstraZeneca plans to move this combination forward in clinical trials.

Nuvelo released positive results from the ANTHEM phase IIa/II trial of rNAPc2 for the treatment of acute coronary syndromes. This multi-center, randomized, double-blind, placebo-controlled, ascending dose-ranging study enrolled 175 subjects in the US and Canada. Subjects received seven ascending doses of rNAPc2 (1.5, 2.0, 3.0, 4.0, 5.0, 7.5 and 10 micrograms/kg) intravenously every 48 hours, along with low molecular weight heparin or unfractionated heparin and aspirin. Results demonstrated that treatment at 7.5 and 10 mcg/kg reduced incidence and duration of ischemia by more than 50%. In the heparin de-escalation portion of the trial rNAPc2 (10 mcg/kg) was shown to reduce ischemia even in the absence of heparin and enoxaparin. Additionally, treatment at 7.5 and 10 mcg/kg suppressed prothrombin fragment F1+2 levels compared to placebo (p<0.01). Hemorrhage rates were 2.5% for placebo, 2.9% for low dose rNAPc2 and 4.5% for higher-dose rNAPc2 (p = 0.77). Based on these results Nuvelo plans to advance rNAPc2 into future trials.

May 15, 2006

Cardiome issued additional results of a phase I trial of an oral formulation of RSD1235, for the treatment of atrial arrhythmia; preliminary results were announced in August 2005. The additional data concerned the drug's effects on QT interval: subjects receiving a 300 mg twice daily dose of the drug had a baseline QT interval of 396 +/- 25 msec, and a value at maximum plasma concentration (Cmax) of 394 +/- 13 msec; the 600 mg twice daily group had a baseline QT of 402 +/- 19 msec, and a Cmax value of 405 +/- 18 msec; and the 900 mg twice daily dose had a baseline QT of 413 +/- 19 msec and a Cmax value of 408 +/- 25 msec. Prolongation of QT interval is a frequent complication of antiarrhythmic therapy, and Cardiome was encouraged by the lack of this complication. The company announced plans to initiate a phase IIb trial of oral RSD1235 in the second half of 2006.

Scios issued positive results of a phase II trial, dubbed NAPA (Nesiritide Administered Peri-Anesthesia in Patients Undergoing Cardiac Surgery) of nesiritide for the maintenance of post-operative renal function following coronary artery bypass graft (CABG). These results were announced at the 7th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke meeting in Washington, DC. Trial data yielded significant improvements in both maximum mean increase in serum creatinine from baseline (0.15+/-0.29 mg/dl for nesiritide, vs. 0.34+/-0.48 mg/dl for placebo; p<0.001), and in maximum decrease in glomerular filtration rate from baseline (-10.8 mL/min/1.73 m2 vs. -17.2 mL/min/1.73 m2; p=0.001). This prospective, multi-center, randomized, double-blind pilot study enrolled 279 heart failure patients scheduled for CABG surgery across 54 sites, who received an infusion of the drug or placebo after induction of anesthesia, with subsequent 14 day follow-up.

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.

December 12, 2005

Medicure has announced positive results of a phase II trial, dubbed MEND-CABG, of MC-1, for the treatment of acute cardiovascular events following coronary artery bypass graft (CABG) surgery. The drug produced significant efficacy in the primary composite efficacy endpoint, significantly reducing incidence of death, non-fatal myocardial infarction (peak CK-MB >/= 100ng/ml) and non-fatal stroke, at a dose of 250 mg, vs. placebo (-37.2%; p=0.028). Additional efficacy was noted in reduction of myocardial infarction (peak CK-MB >/= 100ng/ml) alone, vs. placebo (-46.9%; p=0.008); and in the rate of physician diagnosed myocardial infarction (-78.7%; p=0.0065). The 250 mg dose produced superior efficacy to the 750 mg dose, and neither dose group yielded significant efficacy in the composite endpoint when it included myocardial infarctions with peak CK-MB >/= 50ng/ml. This double blind, parallel group, randomized, placebo-controlled study enrolled 901 CABG patients across 42 sites in Canada and the US, who received one of two daily doses of MC-1 (250 mg or 750 mg) or placebo for 30 days. Based on these results, the company announced plans to move forward with phase III studies of the drug.

December 5, 2005

Alexion and Procter & Gamble announced negative preliminary results of a phase III study, dubbed PRIMO-CABG2, of pexelizumab, for the prevention of myocardial infarction following coronary artery bypass graft (CABG) surgery. Trial data demonstrated a positive trend, but failed to reach statistical significance, in the primary endpoint of reducing the combined incidence of nonfatal myocardial infarction or death through 30 days in moderate-to-high risk patients, compared to placebo. This randomized, double-blind, placebo controlled, parallel assignment study enrolled 4,250 subjects across 250 sites worldwide. The company announced that they were assessing the impact of these results on their other ongoing phase III studies, and full results of PRIMO-CABG2 were to be released in the near future at a major medical conference.

August 29, 2005

EPIX Pharmaceuticals and Schering AG reported results from two phase III trials for MS-325 (gadofosveset trisodium), an investigational contrast agent for vascular imaging with magnetic resonance angiography (MRA). The results show the agent demonstrated higher quality images of the aortoiliac vessels resulting in better agreement with X-ray angiography, the standard of reference, than non-contrast MRA. The trials, called MS-325-12 and MS-325-13, of the first two trials of four total planned studies. Full results were published in the July and September, 2005 issues of the journal Radiology.

August 15, 2005

CV Therapeutics and Astellas issued positive results of a phase III trial of their selective A2A-adenosine receptor agonist regadenoson, under investigation as a pharmacologic stress agent in cardiovascular imaging procedures. Trial data met their primary efficacy endpoint, producing statistical non-inferiority to the approved diagnostic product Adenoscan in myocardial perfusion imaging (MPI). Further, the drug was generally well tolerated, with headache, chest pain, shortness of breath, flushing and gastrointestinal discomfort observed most often. This multinational, randomized, double-blind study enrolled 784 subjects undergoing MPI.

Isis Pharmaceuticals has issued positive results of a phase I study of ISIS 301012, for the treatment of hypercholesterolemia. Trial data indicated that the drug produced rapid reduction (<1 month) in serum levels of apoB-100, and concomitant reductions in LDL levels; median reductions were 60% and 54%, respectively. No treatment related serious adverse events were reported. This open- label study enrolled 6 healthy volunteers with mildly elevated cholesterol, who received 350 mg/week of ISIS 301012 for one month, with subsequent observational follow- up. Based on these results, Isis announced plans to initiate a series of phase II trials of the drug in the second half of 2005.

Nuvelo reported positive results of a phase I trial of alfimeprase, for the treatment of peripheral arterial occlusion (PAO), in the Journal of Vascular and Interventional Radiology. Preliminary safety data yielded a positive tolerability profile, with no serious adverse events reported no incidence of bleeding complications. Drug administration led to a dose-dependent reduction in serum alpha-2 macroglobulin levels (a protein associated with alfimeprase metabolism), which normalized within 14 days of drug administration. No anti-alfimeprase antibodies were detected within 3 months of drug exposure, and no changes in serum plasminogen of fibrinogen levels were detected. Secondary efficacy data indicated thrombolysis and restoration of blood flow in 40% of patients. This multicenter, open-label, dose-escalating study enrolled 20 patients with chronic lower extremity PAO, who received one of 5 intra-arterial doses of the drug (0.025, 0.05, 0.1, 0.3 and 0.5 mg/kg).

ZymoGenetics reported combined results of 4 phase II studies of their investigational surgical homeostatic agent rhThrombin. Pooled data indicated that drug administration tended to increase incidence of homeostasis at 10 minutes (90% vs. 78%), reduce the mean time to homeostasis (194 seconds vs. 250 seconds) and reduce the need for open-label rescue therapy (10% vs. 20%), compared to placebo. When rhThrombin was used as the open-label rescue agent, it was successful in 95% of patients. In addition, there was no difference in the rate of anti-rhThrombin specific antibody formation between drug (n=1) and placebo (n=1) groups. Each trial was a multi-center, randomized, double-blind, placebo- controlled study, in which subjects were administered the drug or placebo through direct application via gelatin sponge to bleed sites warranting topical homeostatic agent application.

April 11, 2005

ImaRx reported positive results of a phase I/II proof of concept study of SonoLysis, for the treatment of dialysis graft occlusion. The drug proved efficacious in clearing occlusive clots from hemodialysis grafts and in improving blood flow after 30 minutes, the study's primary endpoint. No serious safety or tolerability concerns were raised. This open-label study enrolled 22 subjects with clot-occluded dialysis grafts, who received one of several regimens of Sonolysis (MRX-815 nanobubbles in combination with varying intensities of ultrasound) with or without t-PA (an approved thrombolytic).

April 4, 2005

Corautus Genetics has announced positive results from a planned interim analysis of their phase IIb trial of VEGF-2 gene therapy (naked-plasmid vector) for the treatment of severe angina. Results of the interim analysis, based on data from the first 54 patients enrolled in the study, found no significant safety concerns or reported unexpected serious adverse events. These results were deemed sufficient for the trial’s independent data monitoring committee to recommend continuation of enrollment. This ongoing, randomized, double-blinded, dose-ranging and placebo-controlled clinical trial plans to enroll 404 angina patients across roughly 25 US sites. Subjects were to receive treatment with either the VEGF-2 plasmid or placebo, delivered via injection through Boston Scientific’s Stiletto endocardial direct injection catheter system. Corautus expects enrollment to be completed during Q1 2006.

Corgentech and Bristol-Myers Squibb reported negative top-line results of a phase III trial of edifoligide (E2F Decoy), for the prevention of vein graft failure following coronary artery bypass graft (CABG) surgery. Trial data failed to meet the drug’s primary endpoint, with no significant reduction in the incidence of graft failure, defined as blockage of the graft of 75 percent or greater as measured by quantitative coronary angiography at 12 months, compared to placebo. The trial did demonstrate a generally positive safety and tolerability profile, and the company expected full results in the near future. This multi-center, placebo-controlled, double-blind study enrolled 3,014 subjects undergoing CABG surgery, who were randomized to receive a single-dose of either edifoligide or placebo during surgery. Based on these results, the companies announced the termination of their co-development agreement and the discontinuation of development of edifoligide. The ongoing phase I trial of the drug, for the treatment of arterio-venous grafts, was to be completed as planned.

October 4, 2004

ArtheroGenix announced positive interim results from their phase IIb study of AGI-1067, their anti-inflammatory drug for the treatment of artherosclerosis. One year data indicate that the drug demonstrated efficacy in ameliorating coronary artherosclerosis, the trial’s primary endpoint, as measured by a significant reduction in total coronary plaque volume, compared to baseline (p<0.0003). Furthermore, the drug demonstrated efficacy in its secondary endpoint, a significant reduction in total coronary plaque volume among the most seriously diseased patient population, compared to baseline (p<0.0001). The drug demonstrated a trend towards efficacy improvement over standard care, but this trend in the interim was non-significant, and was to be analyzed again at the trial’s conclusion. This placebo-controlled study randomized 266 subjects to receive one of four treatment regimens for 14 days, prior to angioplasty: placebo alone, placebo plus standard care, placebo plus AGI-1067, or AGI-1067 alone. All subjects not on the standard of care regimen received AGI-1067 for 12 months.

Valentis Inc. reported results of a phase II study of their investigational medicine Deltavasc (Del-1 gene plus PINC polymer), for the treatment of the intermittent claudication form of peripheral vascular disease. The trial failed to meet its primary endpoint, with no significant difference in exercise tolerance at 90 days between subjects receiving Deltavasc and subjects receiving PINC polymer alone (the control arm). However, both arms were observed to be clinically active compared to baseline, and both improved disease symptoms and outcomes for primary and secondary endpoint factors: exercise tolerance (p<0.00001 & p=0.0001, respectively), ankle brachial index (an indication of peripheral blood flow; p=0.00665 & p=0.00072), and in the correlation between the two (p=0.039). This double-blind, controlled, trial enrolled randomized a total of 100 intermittent claudication patients to receive Deltavasc (n=49) or PINC polymer alone (n=51) for 90 days. Valentis announced that they planned to initiate a pivotal trial of PINC polymer alone for the treatment of cardiovascular disease, and to examine additional non-cardiovascular development opportunities for Deltavasc.

September 13, 2004

CEL-SCI announced positive results from a clinical trial investigating Multikine, an immunotherapeutic agent for the treatment of elevated cholesterol. Multikine is a mixture of naturally occurring cytokines including interleukins, interferons, chemokines and colony-stimulating factors. Results showed that treatment with Multikine showed no liver toxicity while achieving reduction in total cholesterol levels. A meta-analysis showed the reduction of total cholesterol following treatment with Multikine to be highly statistically significant (p<0.0001). The drug did not affect the levels of AST/ALT (liver enzymes) nor did it produce any severe adverse effects. Subjects were treated with Multikine for 2 to 24 weeks. The study enrolled 120 subjects and was designed to evaluate multiple doses and different treatment regimens in head and neck cancer. Multikine is also under investigation for the treatment of several types of cancer, including head & neck; this is these are the first data reported for the drug for a cardiological indication. The company is now planning to initiate phase III trials for head and neck cancer.

Lilly and Sankyo have reported positive results of a phase II comparative safety study of CS-747, their investigational anti-platelet agent. Trial data met the study’s primary safety endpoint, and demonstrated CS-747 has a comparable safety profile to the current approved therapy clopidogrel: CS-747 produced significant differences in 30-day-post-treatment bleeding in patients who had undergone coronary artery stent implantation. In addition, the trial found non-significant reductions in the incidence of 30-day-post-treatment major coronary events (including death, re-ischemia, target vessel thrombosis, heart attack or stroke; this was the secondary endpoint). The trial enrolled a total of 904 subjects in the US and Canada, who were randomized to receive one of three regimens of CS-747 or a standard regimen of clopidogrel, all of whom had undergone implantation of a coronary stent to open a blocked artery; following the initial dose, all subjects were followed for 30 days for safety and efficacy observations. Based on these results, the companies announced plans to move forward into phase III testing.

June 1, 2004

Alexion Pharmaceuticals and Procter & Gamble Pharmaceuticals reported positive results from a phase III trial investigating pexelizumab, a terminal complement inhibitor for the treatment of coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass. Results showed a significant reduction in the Death/MI (myocardial infarction) composite in the intent to treat population and demonstrated a sustained Death/MI reduction through six months. Data showed that the incidence of death or myocardial infarction was significantly reduced compared to placebo in the intent to treat population. The double-blind, placebo-controlled study, called PRIMO-CABG: "Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery", enrolled 3,099 subjects undergoing CABG. Results were reported in the May 19th, 2004 issue of the Journal of the American Medical Association. The companies plan to initiate a confirmatory phase III trial with pexelizumab in CABG patients in mid 2004.

November 17, 2003

Alexion Pharmaceuticals and Procter & Gamble reported mixed results from a phase III trial investigating pexelizumab, an anti-inflammatory C5 inhibitor designed to treat patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass. Results showed that the primary endpoint did not meet statistical significance, however, the drug did achieve significant reductions in the same Death/MI endpoint in each additional secondary analysis. The primary endpoint was the incidence of death or myocardial infarction (Death/MI) at post-operative Day 30. The incidence of Death/MI was reduced by 9.8% with pexelizumab vs. 11.8 with placebo. The study called PRIMO-CABG (Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery), enrolled over 3,000 subjects undergoing CABG surgery. Results were presented at the American Heart Association Scientific Sessions in Orlando, Florida.

Esperion Therapeutics reported positive results from a phase II trial investigating ETC-216 (ApoA-I Milano /phospholipid complex) for the treatment atherosclerosis. Results showed the drug rapidly reduced the size of plaque in coronary arteries and reversed atherosclerosis. Data revealed a statistically significant reduction in the percent plaque volume in the combined ETC-216 treatment groups comparing end-of-treatment values to baseline values. Overall adverse event rates were similar in all three treatment groups and ETC-216 was generally well-tolerated. The study enrolled 47 subjects with acute coronary syndromes. Subjects received five weekly intravenous infusions of placebo or ETC-216 (15-45 mg/kg). Results were reported in the November 2003 issue of the Journal of the American Medical Association.

October 6, 2003

AVI BioPharma reported positive results from a phase II trial investigating Resten-NG, a Neugene antisense drug for the treatment of cardiovascular restenosis. Results showed a restenosis rate of 33.3% in both the control and 3 mg dose treatment groups, and a 8.3% rate in the 10mg dose group. The 10mg dose group showed a significant reduction of late loss, the decrease in vessel lumen diameter at six months, and lesion length compared with both the control and 3mg groups. There were no increases in toxicity or adverse events in either of the treatment groups. The multicenter, randomized, controlled study, called AVAIL, enrolled 57 subjects. The trial evaluated the safety and effectiveness of Resten-NG in subjects at high risk for cardiovascular restenosis following angioplasty and stent placement. Results were reported at the 15th annual scientific symposium of Transcatheter Cardiovascular Therapeutics in Washington, D.C.

Scios reported positive results from a pilot study investigating Natrecor (nesiritide), a recombinant human B-type natriuretic peptide for the treatment of congestive heart failure. Results showed that weekly infusions of Natrecor for 12 weeks were well tolerated. Less than 1% (11 of 1645) of infusions were discontinued due to side effects. Data demonstrated that the incidence of adverse events was similar in the three groups, and no adverse event occurred significantly more frequently in the Natrecor groups. The multi-center, randomized, three-treatment arm, open-label, study enrolled 210 subjects at high risk for rehospitalization. The study was designed to evaluate the safety and tolerability of weekly infusions of Natrecor administered in an outpatient setting to subjects who were at high risk for hospitalization. Results were presented at the 7th Annual Scientific Meeting of the Heart Failure Society of America in Las Vegas.<

April 21, 2003

Cordis reported positive results from a medical device trial investigating the Cypher sirolimus-eluting coronary stent for the treatment of coronary arterial lesions. Result showed maintenance of the minimal luminal diameter and suppression of neo-intimal hyperplasia. Data demonstrated a survival rate of 92% in subjects treated with the Cypher Stent, compared with a 77% survival rate for subjects treated with the conventional bare metal stent in the control arm of the study. The multi-center, randomized, double blind study called E-SIRIUS, enrolled 352 subjects at 35 sites in Europe.

September 30, 2002

In an open-label, multicenter study, GlaxoSmithKline's Argatroban was found to be safe and effective in the treatment of subjects with heparin-induced thrombocytopenia (HIT) who underwent percutaneous coronary interventions (PCI). The results showed that 98% of the 91 subjects who required PCI and received Argatroban intravenously achieved adequate anticoagulation. These subjects remained free from major complications of death, emergent coronary artery bypass graft surgery and Q-wave myocardial infarction, and only one patient experienced perioprocedural major bleeding. Successful anticoagulation was achieved by 100% of the 21 subjects who required subsequent admissions for PCI.

August 5, 2002

Results of an open-label phase II clinical trial of CVT-3146 indicated that an intravenous bolus of CVT-3146 produced a dose-dependent increase in coronary blood flow velocity. In addition, the magnitude and duration of the increase in coronary blood flow velocity were in line with the developing companies' target profile for the drug's potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. CVT-3146, a selective A2A adenosine receptor agonist, is being co-developed by CV Therapeutics and Fujisawa Healthcare.

March 25, 2002

Phase III trial results indicate that Zetia (ezetimibe) provides additional reductions in LDL-C when co-administered with a statin. All subjects in the "Add-On" trial were diagnosed with hypercholesterolemia, coronary heart disease, and/or multiple risk factors and had not reached their LDL-C goal. Subjects were randomized to receive 10 mg of Zetia or placebo in addition to their current statin dose. Results showed that Zetia reduced LDL-C by an additional 25% when added to the ongoing statin therapy, compared to a 4% reduction with the statin plus placebo. Additionally, Zetia treatment increased HDL-C by an additional 3%, compared to 1% for statin plus placebo, and triglycerides were lowered by an additional 14%, versus 3% for statin plus placebo. Zetia is being developed by Merck and Schering-Plough.

December 10, 2001

Phase IIa trial results suggest that Corvas' rNAPc2 is safe and well tolerated when administered prior to elective percutaneous transluminal coronary angioplasty (PTCA). The randomized, placebo-controlled, double-blind, dose-escalation trial included 156 subjects with stable coronary artery disease undergoing elective PTCA. Five treatment groups received either standard therapy with unfractionated heparin and aspirin or standard therapy plus rNAPc2. Data showed that median femoral compression time (FCT) was similar in all rNAPc2 dose groups compared to placebo except for the highest dose group, which exhibited a statistically significant increase. Additionally, rNAPc2 produced a prolonged, statistically significant suppression of thrombin generation.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.