Seattle Genetics Starts Phase I Study

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Seattle Genetics, Inc. (SGEN) commenced a phase I study to evaluate SGN-LIV1A in patients with LIV-1-positive metastatic breast cancer. Seattle Genetics’ antibody-drug conjugate (ADC) technology has been used for SGN-LIV1A.

The open-label, dose-escalation study will enroll up to 70 patients. The study is enrolling patients with triple negative disease who have previously been treated with at least two prior cytotoxic regimens in the metastatic setting.

Moreover, the study will also enroll patients with ER-positive and/or PR-positive and HER2-negative disease who have previously been treated with at least two prior cytotoxic regimens in the metastatic setting, and at least three prior hormonal therapies.

The primary endpoint is safety, while secondary endpoints include objective response, duration of response and progression-free survival (PFS).

The American Cancer Society anticipates about 230,000 fresh cases of invasive breast cancer to be diagnosed in the U.S. during 2013. At an annual meeting of American Association of Cancer Research, in Apr 2013, preclinical data revealed that up to 92% of breast tumors analyzed expressed LIV-1, with limited expression in normal tissue. In multiple preclinical models, at well-tolerated doses, SGN-LIV1A has shown significant antitumor activity.

In 2013, SGN-LIV1A is one of the four ADCs that have moved to the clinic. ADCs have lately been attracting a lot of interest with major companies entering into collaborations. Seattle Genetics has an alliance with companies such as Roche (RHHBY) and Bayer (BAYRY), for the development of ADCs.

Seattle Genetics carries a Zacks Rank #3 (Hold). Currently, companies like Roche and Actelion Ltd. (ALIOF) look well positioned with a Zacks Rank #1 (Strong Buy).

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