Paolo Tarantino, Research Fellow Dana-Farber Cancer Institute and Harvard Medical School, shared a post on X:
“In light of positive results in the pretreated setting, Celcuity is expanding the 1L VIKTORIA-2 trial of gedatolisib to include patients with endocrine-sensitive tumors. Important additional step: the company is developing a SC formulation of gedatolisib.
‘Gedatolisib Subcutaneous Formulation
To support its long-term lifecycle development plan, Celcuity also announced that it submitted to the United States Patent and Trademark Office (‘USPTO’) its first patent application for a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. Development of the subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.
‘As we initiate pivotal studies for indications that may offer several years of progression-free survival benefit, development of a subcutaneous formulation of gedatolisib would particularly benefit patients who may potentially be receiving treatment with gedatolisib for extended time periods,’ said Brian Sullivan, CEO and co-founder of Celcuity.’ ”
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