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CYTK To Take A Hit, Tune Into ESPR, Watch Out For HALO Effect


A phase II trial evaluating Cytokinetics Inc.'s (CYTK) drug candidate Omecamtiv mecarbil in intravenous formulation as a potential treatment of heart failure, dubbed ATOMIC-AHF, has failed to meet its primary endpoint of dyspnea (shortness of breath) but has shown favorable dose and concentration-related trends on dyspnea response.

Omecamtiv mecarbil, developed by Cytokinetics is licensed to Amgen Inc. (AMGN)under a collaboration and option agreement signed in December 2006.

Another phase II trial known as COSMIC-HF study, is evaluating three modified-release oral formulations of Omecamtiv mecarbil in patients with chronic, stable heart failure and left ventricular systolic dysfunction.

Amgen will decide whether to progress Omecamtiv mecarbil into phase III clinical trials based on results from the COSMIC-HF study, together with the data from ATOMIC-AHF.

Esperion Therapeutics Inc. (ESPR) will be presenting top-line results from a phase 2a study of its lead product candidate, ETC-1002, as an add-on to statin therapy in patients with hypercholesterolemia today (Sep.3) at 8:30 a.m. Eastern Time.

ESPR closed Friday's trading at $16.12, down 4.45%. In after-hours, the stock was down 2.23% to $15.76.

AstraZeneca (AZN) and Bristol-Myers Squibb Co. (BMY) announced that Onglyza, approved in 2009, as once-daily tablet used with diet and exercise to treat Type 2 diabetes in adults has met the primary safety objective in a postmarket study that evaluated cardiovascular outcomes.

In the trial, dubbed SAVOR, the largest cardiovascular outcomes trial to study a diverse population of type 2 diabetes patients at high risk for cardiovascular events, Onglyza demonstrated no increased risk for the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke, when added to a patient's current standard of care (with or without other anti-diabetic therapies), compared to placebo.

However, as previously reported in June of this year, Onglyza did not meet the primary efficacy endpoint of superiority to placebo for the cardiovascular outcomes.

Onglyza garnered sales of $709 million last year.

The subcutaneous formulation of Roche's Herceptin, which utilizes Halozyme Therapeutics Inc.'s (HALO) recombinant human hyaluronidase technology, for the treatment of HER2-positive breast cancer has received marketing authorization in the European Union. The subcutaneous formulation can be administered in two to five minutes, rather than 30 to 90 minutes with the standard intravenous form.

Isis Pharmaceuticals Inc.'s (ISIS) antisense drug candidate ISIS-APOCIIIRx has demonstrated statistically significant mean reductions of up to 79 percent in apolipoprotein C-III and up to 75 percent in triglycerides in patients with very high to severely high triglycerides in a phase II study.

In addition, patients treated with ISIS-APOCIIIRx achieved statistically significant mean increases of up to 57 percent in high-density lipoprotein cholesterol, the 'good' cholesterol, noted the company. Patients also achieved up to 89 percent mean reduction in apoC-III-associated very low-density lipoprotein particles.

ISIS-APOCIIIRx is expected to advance into phase III trials next year in patients with severely high triglycerides.

ISIS closed Friday's trading down 0.31% at $25.83.

by RTTNews Staff Writer

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