Isis Initiates ISIS-STAT3 Study

Zacks Equity Research
May 7, 2013

Isis Pharmaceuticals, Inc. (ISIS) recently announced the initiation of a phase Ib/IIa study on an oncology candidate, ISIS-STAT3 (also known as AZD9150), for advanced metastatic hepatocellular carcinoma (HCC), a type of liver cancer.

The study will assess the efficacy and safety profile of ISIS-STAT3 in HCC patients who have failed first-line treatment.  

Last year, Isis Pharma had reported preliminary results from a dose escalation phase I study of ISIS-STAT3. The candidate demonstrated encouraging efficacy in treatment-refractory advanced cancer patients and showed a promising safety profile. Currently, another phase Ib/IIa trial is ongoing, evaluating the use of ISIS-STAT3 in patients with advanced lymphomas.

Isis Pharma licensed ISIS-STAT3 to AstraZeneca (AZN) as part of an alliance. On Dec 11, 2012, Isis Pharma and AstraZeneca entered into an agreement to discover and develop five new generation antisense oncology candidate, including ISIS-STAT3.

As per the terms of the agreement, Isis received an upfront payment of $25 million and expects to record a payment of $6 million in the second quarter of 2013 from AstraZeneca. Isis will also receive milestone payments and royalties on the sale of commercialized products.

We believe that antisense technology (the main area of focus at Isis Pharma) represents an exciting and potentially revolutionary platform for developing therapeutic candidates to treat a wide array of diseases.

Isis Pharma currently carries a Zacks Rank #1 (Strong Buy). Stocks such as Athersys, Inc. (ATHX) and Cleveland BioLabs, Inc. (CBLI) appear to be equally attractive. Both Athersys and Cleveland BioLabs carry a Zacks Rank #1.

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