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Partners with Humanigen for FDA-approved Phase 3 lenzilumab study for COVID-19 patients
May 8, 2020
By: Contract Pharma
Contract Pharma Staff
Catalent’s clinical partner, Humanigen, has dosed the first COVID-19 patient in its previously announced Phase 3 study for lenzilumab, the company’s proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody. From its Philadelphia, PA facility, Catalent has provided clinical supply support to Humanigen and its partners to accelerate the instigation of this clinical trial. “We are honored to have supported Humanigen on this important project and have ensured that all possible resources were allocated to allow these trials to begin as soon as possible,” said Ricci Whitlow, president clinical supply services, Catalent. “Our team in Philadelphia, and across the company as a whole, feel great pride in doing whatever we can in these times of global uncertainty to help in the treatment of those suffering greatly.” Cameron Durrant, chairman and chief executive officer, Humanigen, said, “I would like to thank the staff at Catalent for their continued work, responsiveness and partnership, which has helped ensure we were able to commence the trial as quickly as we have to evaluate the potential benefits to patients hospitalized with COVID-19 pneumonia and at high risk of progression.” Catalent’s 200,000 square-foot Philadelphia facility provides comprehensive clinical supply services including clinical supply management, comparator sourcing, package engineering primary packaging, secondary packaging and labeling, demand led supply services, cold chain distribution, clinical storage and returns and destruction.
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