Immune Design's Sarcoma Candidate To Enter Phase III In 2018
Zacks Investment Research | Oct 16, 2017 10:04PM ET
Immune Design (NASDAQ:IMDZ) announced that it plans to initiate a pivotal phase III study to support a regulatory application for CMB305, in patients with synovial sarcoma. The company plans to start the study in mid-2018 and enroll 248 patients aged 12 years and older. The decision was based on discussions with the FDA.
The phase III study will evaluate CMB305 monotherapy in comparison to placebo in patients with NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma, who have no evidence of progression after first-line chemotherapy. Patents will be randomized 1:1 to receive either CMB305 monotherapy or placebo. The study will have progression free survival (PFS) followed by overall survival (OS) as co-primary endpoints. If the study meets the PFS endpoint, the candidate may get approved by the FDA.
So far this year, Immune Design’s stock has rallied 83.6% compared with the Zacks Investment Research
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