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SELLAS Life Sciences Announces Completion of Enrollment in Phase 2 Clinical Study of Nelipepimut-S
SELLAS Life Sciences (Nasdaq:SLS) a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced the completion of enrollment for a Phase 2 independent investigator-sponsored clinical trial of the combination of trastuzumab (Herceptin) +/- nelipepimut-S (NPS) targeting high-risk, high-expression HER2-positive (IHC3+) breast cancer patients. As …
SELLAS Life Sciences (Nasdaq:SLS) a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced the completion of enrollment for a Phase 2 independent investigator-sponsored clinical trial of the combination of trastuzumab (Herceptin) +/- nelipepimut-S (NPS) targeting high-risk, high-expression HER2-positive (IHC3+) breast cancer patients.
As quoted in the press release:
 This trial enrolled 100 patients and top-line data are expected in the fourth quarter of 2019.  SELLAS recently reported positive data from a separate Phase 2b study of trastuzumab +/- NPS in low-expression HER2 (IHC 1+/2+) or triple negative breast cancer patients whose tumors are also identified by low-to-no expression of hormone receptors.
This trastuzumab + NPS clinical study is a multi-center, prospective, randomized, single-blinded investigator-sponsored Phase 2 trial focusing on patients with a diagnosis of HER2-positive (immunohistochemistry [IHC] 3+ and/or HER2 FISH-amplified) breast cancer who are HLA-A02, A03, A24 or A26-positive and at high-risk for recurrence after standard therapy for early-stage disease. Â Eligible patients were randomized to receive NPS plus trastuzumab or trastuzumab alone in the adjuvant setting to prevent or delay disease recurrence. The primary endpoint of the study is disease-free survival (DFS). Support for this trial is provided, in part, by the Congressionally Directed Medical Research Program (CDMRP), funded through the Department of Defense via a Breast Cancer Research Program Breakthrough Award to Elizabeth Mittendorf, MD, PhD. Â The National Breast Cancer Coalition led the effort to establish the CDMRP to enhance the funding for breast cancer research and remains integrally involved in the grant selection process.
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