On April 26, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the Company has launched a Pre-Approval Access/Expanded Access Program ("EAP") with SELLAS’ lead asset, GPS, for treating patients suffering from acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, APR 26, 2022, View Source [SID1234612974]).
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GPS is an immunotherapeutic that targets the Wilms Tumor 1 (WT1) protein. The Company is currently testing GPS as a monotherapy in a pivotal Phase 3 clinical trial (the REGAL trial) in patients with AML who have achieved second complete remission, as well as in combination with PD1 inhibitors in earlier stage clinical trials.
"After receiving multiple requests from physicians who have been following GPS and its results to date, it became clear, particularly under the 21st Century Cures Act, that we needed to initiate an EAP quickly to help patients around the world with AML, an aggressive form of cancer that progresses rapidly without the proper treatment," said Angelos Stergiou, MD, ScD. h.c., President and CEO, SELLAS. "SELLAS is firmly committed to its mission to improve clinical outcomes for these patients and their families who want to consider all possible therapeutic options, as well as ensuring that we are bringing a new, safe and potentially effective treatment option to physicians and patients in need."