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CytoDyn Submits Protocol To FDA For Phase 2b Clinical Study Of PRO 140 For Treatment Substitution In Patients With HIV



2/18/2014 9:59:10 AM

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VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that the Company has submitted a Phase 2b clinical trial protocol, for its lead product candidate, PRO 140, to the U.S. Food and Drug Administration for treatment substitution in patients with Human Immunodeficiency Virus (HIV). PRO 140 is a humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells, and belongs to a class of HIV therapies known as entry inhibitors that block HIV from entering into and infecting certain cells. In this Phase 2b study, the Company’s primary objective is to assess the efficacy of PRO 140 monotherapy for the maintenance of viral suppression in HIV patients who are stable on combination antiretroviral therapy, known as HAART (highly active antiretroviral therapy), but need or wish to discontinue HAART therapy temporarily.

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