Isis Pharmaceuticals, Inc.
) 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.
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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
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
Isis Pharma was recently in news when it received a $7.5 million
milestone payment from
). 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
) 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.
) looks more attractive in the pharma sector with a Zacks Rank #2