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Lupus Clinical Trials

New Medical Therapies™


April 2, 2007

AstraZeneca reported positive results from a phase III trial, dubbedMETEOR (Measuring Effects on intima media Thickness: an Evaluation OfRosuvastatin), of Crestor for the treatment of atherosclerosis. This 24-month,randomized, double-blind, placebo-controlled trial enrolled 984 asymptomatic,hypercholesterolaemic subjects with a low-risk of coronary artery disease andevidence of sub-clinical atherosclerotic disease. Results demonstrated thatsubjects taking Crestor 40 mg experienced a 0.0014 mm/yr decrease in the meanmaximum carotid intima-media thickness, a marker of atherosclerotic burden,compared to a progression of 0.0131 mm/yr for those on placebo (p≤0. 0001). Inaddition, Crestor demonstrated a 48.8% reduction in LDL-C and an 8. 0% increasein HDL-C (both p≤0.0001 vs placebo). AstraZeneca plans to file a NDA and MAAfor Crestor in the treatment of atherosclerosis in the first half of 2007.

Scios issued positive results from a phase II trial, dubbed FUSION II(Follow-Up Serial InfusiOns of Natrecor in Advanced Heart Failure), for thetreatment of chronic decompensated heart failure (CDHF). This randomized,placebo controlled, double-blind trial enrolled 920 subjects internationally.Subjects received once- or twice-weekly infusions of Natrecor or placebo, alongwith optimized heart failure medications. The primary endpoint was a compositeof death and cardiorenal hospitalization at 12 weeks. Results revealed nostatistically significant difference in the primary endpoint between the twogroups when each was added to optimal heart failure medications, significantuse of indicated heart failure devices and intensive disease management. Basedon the results, Scios plans to move forward with future trials.

November 29, 2004

AtheroGenics has issued mixed results of a phase IIb trial of their investigational anti-inflammatory drug AGI-1067, for the treatment of atherosclerosis. Trial data met their primary efficacy endpoint in coronary atherosclerosis, with patients receiving Standard of Care (SC) plus AGI-1067 exhibiting a significant reduction in average total plaque volume of 3.9 mm3 (2.3%; p=0.0015) after 12 months of treatment, compared to baseline. SC plus placebo treatment yielded a non-significant decrease in average total plaque volume of 1.5 mm3 (0.8%; p=0.45) compared to baseline, but this minor reduction was sufficiently large to make the difference between SC-plus-AGI-1067 and SC-plus-placebo non-significant (p=0.29). The data also met important secondary endpoints, significantly reducing levels of myeloperoxidase, an inflammatory biomarker linked to increased risk of heart attack, and producing a highly significant reduction in total average plaque volume of 1.8 mm3 (4.8 %; p<0.0001) in the subset of the most severely diseased patients. This double-blind, placebo-controlled study enrolled a total of 469 subjects, who were randomized to receive SC plus either one of three regimens of AGI-1067 or placebo for 12 months.

October 25, 2004

deCODE genetics issued positive preliminary results of a phase IIa trial of DG031, their investigational cardioprotective for the prevention of heart attack. Trial data met their primary efficacy endpoint, demonstrating a significant reduction in one or more biomarkers of heart attack, in at-risk patients. This included a significant reduction of leukotriene B4 at all investigational doses, and significant reductions of MPO and sICAM-I at the highest investigational dose, compared with placebo. No serious tolerability concerns were raised, though one myocardial infarction occurred in the active drug group and one sudden death occurred in a subject receiving placebo. This double-blind, placebo-controlled, dose-escalating crossover study enrolled 172 subjects with a history or a genetic predisposition to heart attack.

Liponex has issued preliminary results from a phase I trial of CRD5, for the treatment hypercholesterolemia and atherosclerosis. Data from the trial showed that drug was safe and well tolerated with no adverse reactions reported, meeting their primary endpoint. In addition, secondary efficacy data indicated that the drug showed significant efficacy in both increasing HDL (good) cholesterol (18% over baseline) and reducing LDL (bad) cholesterol (15%-60% from baseline). This open-label study enrolled 56 healthy volunteers, who received CRD5 for two weeks. Based upon these results, Liponex announced plans to initiate phase II trials of CRD5 in 2005.

Vertex Pharmaceuticals reported preliminary results from a phase IIa trial of VX-702, their investigational p38 MAP kinase inhibitor, for the treatment of acute coronary syndrome in patients undergoing percutaneous coronary intervention. Study results indicate that the drug met its primary safety and pharmacokinetic endpoints, with no significant increase in adverse events compared with placebo, and no significant difference in incidence of liver enzyme abnormalities. The drug also met its secondary efficacy endpoints, significantly reducing serum C-reactive protein (CRP) levels up to 48 hours after treatment in all dosing cohorts compared with placebo. This double-blind, placebo-controlled dose escalation study enrolled a total of 45 patients with unstable angina and acute coronary syndrome. Subjects were randomized to receive one of four doses of the drug or placebo once daily for five days, prior to PCI intervention.

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.<

September 8, 2003

Cordis reported positive final results from a medical device trial investigating the CYPHER Sirolimus-eluting coronary stent for the treatment of arterial blockage. Results demonstrated sustained improvement in vessel re-narrowing at 12-month follow-up compared to a conventional bare metal stent. Data also showed a trend towards lower re-blockage rates in subjects treated with the CYPHER Stent without pre-dilation. Earlier results showed that 43.6% of subjects who received the standard metal stent exhibited reblockage compared with 5.8% of subjects treated with the CYPHER. The study, called E-SIRIUS enrolled 352 subjects at 35 sites in Europe. Results were presented at the 2003 European Society of Cardiology Congress in Vienna.

King Pharmaceuticals and Wyeth reported positive results from a post-marketing trial investigating Altace (ramipril), an ACE inhibitor for the prevention of cardiovascular disease. Results showed a sustained effect of ramipril on the prevention of cardiovascular disease and no preventive effects of vitamin E. The study was conducted by the Population Health Research Institute at McMaster University and Hamilton Health Sciences in Hamilton, Ontario, Canada. Results were presented at the European Society of Cardiology Meeting in Vienna, Austria. The HOPE-TOO (HOPE-The Ongoing Outcomes) study began in November 1999 and examined the benefits seen with 4.5 years of treatment with ramipril were sustained and whether longer-term treatment with vitamin E protected against the development of cancer and cardiovascular disease.

Novartis reported positive results from a clinical trial investigating everolimus, an immunosuppressant drug for the treatment of complications from heart transplants. Results showed that everolimus was significantly more effective in reducing the severity and incidence of serious transplant complications than current therapy. Data also showed that everolimus significantly reduced the incidence of cytomegalovirus infection. The two-year international study was conducted at 52 medical centers in four countries and enrolled 634 subjects with heart transplants who were given the standard regimen of cyclosporine and steroids in addition to treatment medication. The study was designed to target acute rejection and cardiac allograft vasculopathy. Results were presented in the Aug. 28th issue of The New England Journal of Medicine.

March 10, 2003

Texas Biotechnology and GlaxoSmithKline reported positive results from a phase II trial investigating Argatroban, a synthetic direct thrombin inhibitor for the treatment of ischemic stroke. Results showed the drug produced Intracranial Hemorrhaging (ICH) at a rate comparable to placebo. The primary endpoint of safety, defined as symptomatic intracranial hemorrhage within 30 days, confirmed by computerized tomography, was successfully met with no statistically significant differences between the treatment group vs. placebo. The secondary endpoints, defined as asymptomatic ICH, major systemic hemorrhage, minor systemic bleeding, and efficacy for each group and stroke showed no significant differences from placebo. The double- blind, randomized study, called ARGIS-I (Argatroban in Acute Ischemic Stroke), enrolled 176 ischemic stroke subjects. Subjects were given Argatroban or placebo to achieve two different levels of anticoagulation within 12 hours from symptom onset.

January 27, 2003

Spectranetics reported positive results from a pivotal phase II trial investigating LACI (Laser Angioplasty Critical Limb Ischemia), an experimental device for the treatment of limb ischemia. Data showed that the primary endpoint, six-month survival with limb salvage, was achieved in 93% of treatments compared to 87% in the control group. Results showed significant adverse events in treated subjects were nearly 50% less than those of the control group. The trial enrolled 145 subjects who were poor surgical candidates at 14 U.S. and several European sites. Trial data was compared to a control group consisting of 789 subjects with critical limb ischemia treated with a variety of standard therapies.

October 7, 2002

Interim results in an ongoing phase II trial indicated that Resten-NG was effective in preventing coronary artery restenosis after angioplasty and stent placement for the treatment of atherosclerotic lesions. Subjects were randomized to three treatment groups, including a control group who received no drug treatment and two groups who received a 3 or 10 mg dose of Resten-NG. After a six-month follow-up, subjects who received 10 mg of Resten-NG had an 11% restenosis rate and an 80% reduction in restenosis while the control group and the 3 mg of Resten-NG group averaged approximately a 50% restenosis rate. AVI BioPharma is developing Resten-NG.

July 22, 2002

Esperion Therapeutics reported positive results from a phase I trial of ETC-642 in subjects with stable atherosclerosis. The trial, which evaluated five dose levels of a single ETC-642 intravenous infusion, included 28 subjects who were monitored for four weeks after dosing. Results showed that ETC-642 was safe and well tolerated at all dose levels tested. In addition, the data showed evidence of increases in HDL-cholesterol levels and rapid cholesterol mobilization.

June 17, 2002

Positive results were reported from a phase I trial of AC3056, an investigational compound for the treatment of atherosclerosis and other conditions related to the obstruction of blood vessels. In the double-blind, placebo-controlled, crossover trial, 14 healthy subjects received an oral formulation of AC3056 in a dose-escalating manner. Results showed dose-dependent increases in blood levels of AC3056, as well as dose-dependent increases in serum antioxidant activity. The drug was well tolerated with no safety concerns. AC3056 is being developed by Amylin Pharmaceuticals.

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.