Lilly : Effient® Added to Updated ACCF/AHA Clinical Guidelines for ACS-PCI Patients with Unstable Angina and Non-ST Segment Myocardial Infarction

March 29, 2011 - Lilly - Oral antiplatelet therapy Effient® (prasugrel) has been added to the updated clinical practice guidelines as a Class I recommended treatment option for patients undergoing percutaneous coronary intervention (PCI) after experiencing heart-related chest pain at rest (unstable angina) or non-ST segment elevation myocardial infarction (NSTEMI). NSTEMI is a type of heart attack that that does not need to be treated with emergent opening of a blocked coronary artery. The update to the clinical guidelines, jointly developed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA), was published online on March 28, 2011, in the Journal of the American College of Cardiology and Circulation.

"Class I" means that a given "procedure/treatment should be performed/administered" to patients, given it was found to be "useful/effective/beneficial." Class I is the highest recommendation provided by the guidelines committee.

Effient tablets are approved by the U.S. Food and Drug Administration to reduce the risk of future heart-related events, such as heart attack or stent thrombosis, in patients with acute coronary syndromes (ACS) who are treated with PCI. ACS includes heart attack and unstable angina (UA)... Eli Lilly and Company's Press Release -

Cerenis : Phase 2 Study of Lead Product Candidate, CER-001, in Patients with Acute Coronary Syndrome »

March 15, 2011 - Cerenis Therapeutics, a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and metabolic diseases, announced the start of the Phase 2 CHI-SQUARE (Can HDL Infusions Significantly Quicken Atherosclerosis Regression?) study of CER-001 in patients with acute coronary syndrome (ACS).

CER-001 is an innovative complex of recombinant human ApoA-I, the major structural protein of HDL, and phospholipids. It has been designed to mimic the structure and function of natural, nascent HDL, also known as pre-beta HDL, which is believed to be protective against atherosclerosis. It is hoped that CER-001 will further reduce cardiovascular events in high-risk patients by promoting removal of cholesterol from the vessel wall.

The double-blind, randomized, placebo-controlled, safety and efficacy study will assess the ability of CER-001 to regress coronary atherosclerotic plaque as measured by intravascular ultrasound (IVUS). The study will include over 500 patients at 50 centers in the US, Canada and Europe, and will evaluate three different dose levels given in six weekly intravenous infusions... Cerenis Therapeutics' Press Release -

AtCor Medical : US$0.6 million new pharmaceutical contract

8 March 2011 - AtCor Medical (ASX: ACG), the developer and marketer of the SphygmoCor® system, which measures central blood pressures and arterial stiffness noninvasively, announced that it has signed a new US$0.6 million agreement to supply SphygmoCor systems and clinical trial support services to a major international pharmaceutical company.

Duncan Ross, CEO of AtCor Medical said, “AtCor has converted another contract due to the strength of both SphygmoCor technology and our clinical trial applications and data management services in pharmaceutical trials. We are especially pleased that the assessment of central pressures and arterial stiffness continues to grow beyond hypertension therapies, such as this study, and across disease states as drug companies endeavor to fully characterize the clinical benefits of new and existing drug therapies”. Mr Ross continued “over the past five years there has been mounting evidence of both positive and detrimental effects on central pressures and arterial stiffness in a number of drug classes which has captured the attention of both regulators and the pharmaceutical industry.”... [PDF] AtCor Medical's Press Release -

Novartis : positive CHMP opinion for Rasilamlo(TM), a single-pill combination of aliskiren and amlodipine to treat high blood pressure

February 18, 2011 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Rasilamlo(TM) (aliskiren and amlodipine) to treat high blood pressure patients not adequately controlled by either aliskiren or amlodipine alone. Rasilamlo combines in a single pill the only approved direct renin inhibitor worldwide, Rasilez®, with the widely used calcium channel blocker amlodipine.

The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in approximately three months.

"We are delighted with the CHMP opinion because it means that Rasilamlo could soon be made available to patients in the EU in need of effective combination treatments to help control their high blood pressure," said David Epstein, Division Head of Novartis Pharmaceuticals. "Novartis understands the complex needs of high blood pressure patients and is committed to furthering cardiovascular research and to developing innovative and effective treatments."... Novartis' Press Release -

Viron : Phase 2a Data Published in Leading Cardiovascular Journal

December 16, 2010 - Viron Therapeutics Inc. announced that the results of Viron's Phase 2a trial for VT-111 were published in Circulation: Cardiovascular Interventions. In the study led by Dr. Jean-Claude Tardif, Director of the Research Centre at the Montreal Heart Institute, VT-111, also known as Serp-1, met both its primary and secondary endpoints of safety and biological activity in Acute Coronary Syndrome (ACS) patients receiving coronary stents. VT-111 is a protein produced by the myxoma virus that allows the virus to lower its host's inflammatory response to infection.


"Although the use of cardiovascular stents have dramatically improved the outcomes for patients with occlusive coronary artery disease, numerous studies have shown that the procedure itself can cause what is termed peri-procedural myocardial injury (PMI)," said James Rae, CEO of Viron. "A recent review in the European Heart Journal shows that 30% of patients receiving coronary stents sustain an injury to the heart tissue arising from the procedure itself and the biomarkers most useful in measuring this cardiac injury are CK-MB and Troponin I. Viron's Phase 2a trial showed a statistically significant, dose-dependent reduction in these two key biomarkers of cardiac damage, at multiple timepoints, with a particularly potent effect in the first 24 hours after the placement of the stent. If the incidence of PMI was reduced, clinical outcomes would improve for many of the almost 3 million patients each year that receive cardiac stents in North America and Europe." ... Viron Therapeutics' Press Release -