CytoDyn’s PRO 140 treats patient suffering from GvHD in Phase 2 trial

CytoDyn In. announced the treatment of the first patient suffering from GvHD(Graft versus Host Disease) with use of PRO 140 during its clinical trial Phase 2.

The multicenter, 60-patient Phase 2 trial will evaluate the safety and efficacy of PRO 140 with an equal number of patients receiving PRO 140 and placebo. The trial is supported by study data using a xeno-GvHD animal model where human bone marrow stem cells were administered to immunocompromised mice, which leads to severe GvHD culminating in death. PRO 140 at a comparable dose to that being employed in CytoDyn’s Phase 2 trial completely eliminated any signs of GvHD in these mice. Effects of stem cell engraftment was apparent in blood, spleen and bone marrow of the mice without signs of GvHD. This preclinical study is being submitted to the U.S. Food and Drug Administration (FDA) in support of CytoDyn’s Orphan Drug Designation application and publication of this data is forthcoming.

CytoDyn’s Chief Science Officer, Denis R. Burger said that they selected the transplantation indication called GvHD as our first expansion of PRO 140 into a non-HIV clinical indication because it targets the CCR5 receptor, which is known to be an important mediator of GvHD, especially in the organ damage that is the usual cause of death. They plan to explore additional opportunities to expand the clinical applications of PRO 140 to those indications where CCR5 plays an important role, namely certain autoimmune diseases and cancer.

If CytoDyn receives positive results from this Phase 2 study, the Company expects to file for Breakthrough Designation with the FDA to expedite the commercialization of PRO 140 for this clinical indication. As previously reported, PRO 140 is considered safe and well tolerated with negligible toxicities or side effects.

GvHD occurs after a bone marrow or stem cell transplant in which an individual receives bone marrow tissue or cells from a donor, known as allogeneic transplant. The transplanted cells regard the recipient’s body as foreign and attack the recipient’s body. GvHD does not occur when an individual receives his or her own cells during a transplant. Before a transplant, tissue and cells from possible donors are tested to determine how closely they match the person having the transplant with GvHD is less likely to occur, or symptoms to be milder, when the match is close. The chance of GvHD can be between 30% and 40% when the donor and recipient are related and 60% to 80% when the donor and recipient are not related. There are two types of GvHD: acute and chronic. Symptoms in both acute and chronic GvHD range from mild to severe.  Acute GvHD usually occurs within the first three months after a transplant.