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Isis Pharmaceuticals Starts Phase III Study on ISIS-APOCIIIRx

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Isis Pharmaceuticals, Inc. (ISIS) has initiated a phase III study which will evaluate the use of ISIS-APOCIIIRx in patients suffering from familial chylomicronemia syndrome (FCS).

FCS is an orphan disease characterized by very high levels of triglyceride (above 2,000 mg/dL). It is estimated to affect 3,000 to 5,000 patients across the world. FCS patients often suffer from other health issues like recurrent episodes of pancreatitis.

The randomized, double-blind, placebo-controlled, six-month study will enroll approximately 50 FCS patients with the primary endpoint being percentage change in fasting triglycerides from baseline after three months of dosing.

We remind investors that earlier this year the company had reported encouraging results from a phase II study on ISIS-APOCIIIRx in patients with FCS. Isis Pharma stated that three FCS patients on ISIS-APOCIIIRx experienced a significant reduction in triglycerides – below 500 mg/dL – thereby leading to a significant decline in the risk of an acute pancreatitis event.

Apart from developing ISIS-APOCIIIRx for patients with FCS, Isis Pharma is also developing the candidate for patients suffering from severely elevated triglycerides (greater than 880 mg/dL). The company is planning to initiate a phase III program evaluating ISIS-APOCIIIRx in patients suffering from severely elevated triglycerides later this year.

Isis Pharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Amgen Inc. (AMGN), Gilead Sciences Inc. (GILD) and Alexion Pharmaceuticals, Inc. (ALXN). While Amgen and Gilead are Zacks Rank #1 (Strong Buy) stocks, Alexion carries a Zacks Rank #2 (Buy).

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