(SGEN) Seattle Genetics Starts SGN-CD19A Phase I Study

Seattle Genetics Inc. (SGEN) recently commenced two phase I clinical studies with its oncology candidate, SGN-CD19A. The two trials will assess the safety and anti-tumor response of SGN-CD19A in CD19-positive acute lymphoblastic leukemia (ALL) and B-cell non-Hodgkin lymphoma (HL) patients.

Establishing the maximum tolerated dose and examining the safety of the candidate are the two primary endpoints of the trials. The trials will also assess antitumor activity, pharmacokinetics, progression-free survival (PFS) and overall survival (OS).

According to the American Cancer Society, more than 70,000 cases of non-HL and roughly 6,000 cases of ALL were expected to be diagnosed in the US during 2012 and almost 19,000 people were expected to die from non-HL and more than 1,400 were expected to die from ALL.

Meanwhile, Adcetris recently received approval under Health Canada’s Notice of Compliance with conditions (NOC/c) for the treatment of relapsed or refractory HL and systemic anaplastic large cell lymphoma (sALCL).

For similar indications, Adcetris was approved by the US Food and Drug Administration (FDA) in Aug 2011 and in the EU in Oct 2012.

Adcetris, Seattle Genetics’ only approved drug, generated revenues of $102.8 million for the nine months ending Sep 30, 2012.

In Jan 2013, a global phase III study (ECHELON-2) was initiated on Adcetris. In this study, Adcetris plus chemotherapy will be evaluated for the front-line treatment of CD30-positive mature T-cell lymphoma (MTCL) including patients with sALCL and other types of peripheral T-cell lymphomas.

Seattle Genetics currently carries a Zacks Rank #4 (Sell). Right now, Peregrine Pharmaceuticals, Inc. (PPHM), Agenus Inc. (AGEN) and Targacept, Inc. (TRGT) look more attractive with a Zacks Rank #1 (Strong Buy).
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