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Clinical Trials

Date: 2015-06-24

Type of information: Initiation of development program

phase:

Announcement: initiation of development program

Company: CytoDyn (Canada)

Product: PRO 140

Action mechanism:

monoclonal antibody/viral-entry inhibitor. PRO 140 belongs to a new class of HIV/AIDS therapeutics -- viral-entry inhibitors -- that are intended to protect healthy cells from viral infection. PRO 140 is a fully humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. PRO 140 blocks the predominant HIV (R5) subtype entry into T-cells by masking this required co-receptor, CCR5. Importantly PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. Cytodyn acquired the product from Progenics in 2012.

Disease: graft-versus-host disease (GvHD) 

Therapeutic area: Immunological diseases - Transplantation

Country:

Trial details:

Latest news:

* On June 24, 2015, CytoDyn, a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, announced that recent Company research data has expanded the potential clinical indications for PRO 140, now in Phase 3 for the treatment of HIV, to include certain inflammatory diseases, autoimmunity, transplantation and cancer. The chemokine receptor, CCR5, is expressed on a variety of cells that play a central role in inflammatory responses. The receptor is activated by a chemokine mediator called CCL5, which has been shown to be a central figure in many inflammatory disease processes. Blocking the interaction of CCL5 with the receptor CCR5 is believed to be of therapeutic benefit. The monoclonal antibody PRO 140 targets the chemokine receptor CCR5, binding to it in a way that prevents HIV from using it as an entry gateway without activating the immune function of the receptor. The Company\'s recent research data indicate that PRO 140 also interferes with activation of the receptor by the mediator CCL5.

The Company has selected a transplantation indication called Graft versus Host Disease (GvHD) as its first non-HIV clinical indication. The CCR5 receptor, the target for PRO 140, is an important mediator of GvHD, especially in the organ damage that is the usual cause of death. The only approved CCR5 inhibitor, Maraviroc, is currently in a Phase 2 study in GvHD and results are expected in 2016. The Company believes that PRO 140 has significant advantages over Maraviroc in more favorable dosing and pharmacokinetics, less toxicity and side effects, and no direct stimulation (agonist activity) of the CCR5 receptor.

Is general: Yes