Patient enrollment proceeding under amended protocol
CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company developing new antibody therapies for combating human immunodeficiency virus (HIV) infection and immunologic indications, announces that an amended protocol for the Phase 2 trial with PRO 140 in patients with graft-versus-host disease (GvHD) has received central Institutional Review Board (IRB) approval and patient enrollment is underway at five clinical sites.
Following a previously announced meeting of an independent data monitoring committee’s (iDMC) review of data from the first 10 patients in the Phase 2 trial, CytoDyn filed amendments to the protocol with the U.S. Food and Drug Administration (FDA). The amendments include switching the pre-treatment conditioning regimen from aggressive myeloablative (MA) conditioning to a reduced intensity conditioning (RIC), and switching from a blinded one-for-one randomized placebo-controlled design to an open-label design under which all enrollees receive PRO 140. The amendments also provide for a 50% increase in the dose of PRO 140 to more closely mimic preclinical dosing. The next review of data by the iDMC will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days.
“Our revised protocol is both expected to improve the rate of enrollment and is supported by our findings from recently published studies that were not available when the original protocol was designed about two years ago,” stated Denis R. Burger, Ph.D., CytoDyn’s Chief Science Officer. “We are optimistic about the therapeutic benefit for PRO 140 in GvHD based on previous clinical trials demonstrating the ability of this therapeutic candidate to target the CCR5 receptor, which is known to be an important mediator of this potentially life-threatening disorder.”