Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19
FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ -- Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19. The University of California Irvine is the first CA site to open for patient enrollment.
CIRM's COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.
"Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses," said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. "We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California."
Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says "CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection."
The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.
The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.
Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.
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