Seattle Genetics (SGEN) Initiates ADCETRIS Phase II
Tweet
Share
E-mailGet Alerts SGEN Hot Sheet
Join SI Premium – FREE
Seattle Genetics, Inc. (Nasdaq: SGEN) has initiated a phase II clinical trial of ADCETRIS (brentuximab vedotin) for patients with CD30-positive non-lymphoma malignancies, including multiple myeloma, leukemia and solid tumors. The trial is designed to assess the antitumor activity and safety profile of ADCETRIS in these patients. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. On August 19, 2011, the U.S. Food and Drug Administration granted accelerated approval of ADCETRIS for two indications. ADCETRIS has not been approved for use in any non-lymphoma malignancies.
The phase II trial is enrolling patients with CD30-positive non-lymphoma malignancies who have failed, refused or have been deemed ineligible for standard therapy. Assessment of CD30 expression will be performed according to a Seattle Genetics screening protocol. The screening protocol facilitates high-throughput assessment of CD30 expression in patients with a variety of non-lymphoma malignancies to identify those eligible for the clinical trial. The primary endpoint of the phase II trial is characterization of the antitumor activity of ADCETRIS. In addition, the trial will assess safety and establish the relationship of CD30 expression with antitumor activity. The study is expected to enroll approximately 40 patients at multiple centers in the United States.
The phase II trial is enrolling patients with CD30-positive non-lymphoma malignancies who have failed, refused or have been deemed ineligible for standard therapy. Assessment of CD30 expression will be performed according to a Seattle Genetics screening protocol. The screening protocol facilitates high-throughput assessment of CD30 expression in patients with a variety of non-lymphoma malignancies to identify those eligible for the clinical trial. The primary endpoint of the phase II trial is characterization of the antitumor activity of ADCETRIS. In addition, the trial will assess safety and establish the relationship of CD30 expression with antitumor activity. The study is expected to enroll approximately 40 patients at multiple centers in the United States.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris
- Kimbell Royalty closes $221.2M mineral rights acquisition
- Gray Media closes $750M note offering to refinance higher-rate debt
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
