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Isis Pharma Initiates Phase II Study on ISIS-APO(a)

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Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Late last week, Isis Pharmaceuticals, Inc. announced that it has initiated a randomized, placebo-controlled, dose-titration phase II study on ISIS-APO(a) in patients suffering from high lipoprotein(a) – Lp(a). The study will evaluate the safety and efficacy of ISIS-APO(a) over a 12-week period.  

Increased level of Lp(a) is a genetically determined indication, which is not adequately responsive to diet and lifestyle changes. According to Isis Pharma, medical awareness about the role played by Lp(a) in causing cardiovascular disease is gradually increasing.

Given that many patients suffer from cardiovascular disease resulting from high Lp(a) levels, despite having normal LDL-cholesterol levels, we believe there is need for new treatments targeting Lp(a). If successfully developed and commercialized, ISIS-APO(a) will be the first drug designed specifically for the treatment of patients suffering from Lp(a)-caused cardiovascular disease.  

Meanwhile, Isis Pharma is conducting a phase II/III study on ISIS-TTR in patients suffering from familial amyloid polyneuropathy (FAP). Last week, the company announced that it has earned a $1 million milestone payment from GlaxoSmithKline (GSK - Free Report) pertaining to the advancement of ISIS-TTR in the phase II/III study. The latest payment of $1 million marks the fifth installment of the total milestone payment of approximately $58 million that Isis Pharma is eligible to receive from Glaxo for the development of ISIS-TTR.

Isis Pharma and partner Glaxo are also conducting an open-label extension study on ISIS-TTR in FAP patients who have completed dosing in the phase II/III study.

Isis Pharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Actelion Ltd. and Biogen Idec Inc. (BIIB - Free Report) . Both stocks carry a Zacks Rank #1 (Strong Buy).

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