Isis Pharmaceuticals, Inc. (ISIS) recently announced that it has initiated a phase II study (n = 20) to evaluate the safety and efficacy of its paroxysmal atrial fibrillation (AF) candidate, ISIS-CRP.
The randomized, placebo-controlled, multiple-dose, phase II study will evaluate the use of ISIS-CRP, as a monotherapy, in patients suffering from AF, who have pacemakers. The study will assess the effectiveness of ISIS-CRP on frequency and duration of AF episodes.
The company is also evaluating the use of ISIS-CRP in rheumatoid arthritis (:RA) patients with chronically elevated CRP levels. Data from a phase II study for the RA indication is expected in mid-2013.
Isis Pharma was recently in news when it received a $7.5 million milestone payment from GlaxoSmithKline (GSK). The payment primarily relates to the initiation of a phase II/III clinical study of ISIS-TTRRx. The study will span 15 months enrolling 200 patients. Isis is developing ISIS-TTRRx in collaboration with Glaxo for the potential treatment of transthyretin (:TTR) amyloidosis.
We note that Isis Pharma’s lead product, Kynamro (mipomersen sodium), received FDA approval in Jan 2013 for the treatment of familial hypercholesterolemia (:FH). Isis Pharma’s partner Sanofi (SNY) is marketing the product in the US. Sanofi is also looking to get the drug approved in the rest of the world including Europe.
Isis Pharma currently carries a Zacks Rank #3 (Hold). Though impressed by Isis Pharma’s pipeline, we expect investor focus to remain on Kynamro’s ramp up. Medivation Inc. (MDVN) looks more attractive in the pharma sector with a Zacks Rank #2 (Buy).
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