CytoDyn Inc (OTCMKTS:CYDY)
CytoDyn Inc (OTCMKTS:CYDY) has announced treatment of the first patient in its Phase 2 clinical study examining Graft versus Host Disease- GvHD, the company’s leading immunologic indication for PRO 140. CytoDyn is a biotechnology company engaged in the development of new drugs used in the fight against human immunodeficiency virus (HIV) infection.
Graft versus Host Disease is a dangerous and life-threatening condition in patients in need of bone marrow transplant due to the weak immune system. This results from aggressive cancer treatment for some types of leukemia. GvHD have a one-year survival rate of 40-60%.
The Phase 2 trial is a multicenter study admitting a total of 60 patients and will seek to evaluate the level of safety and efficacy of PRO 140 with an equal number of patients administered with PRO 140 and placebo. The study is supported by data from a xeno-GvHD animal model which administered human bone marrow stem cells to immunocompromised mice. This leads to severe GvHD which leads to death. PRO 140 helped cure signs of GvHD in the mice at the same dose as that which is being used in CytoDyn’s Phase 2 study. The xeno-GvHD animal model reported signs of stem cell engraftment in blood, bone marrow, and in the spleen’s of the mice without GvHD signs. The preclinical trial will be submitted to the U.S. Food and Drug Administration (FDA) to augment the company’s application for Orphan Drug Designation application. The data will be published soon.
CytoDyn Inc (OTCMKTS:CYDY)’s Chief Science Officer Denis R. Burger, Ph.D says the company will be working to explore more opportunities of expanding the clinical functions of PRO 140 so as to accommodate those indications where CCR5 has a crucial role, i.e. cancer and some auto-immune diseases.
In the event that the Phase 2 study reports positive data, CytoDyn Inc (OTCMKTS:CYDY) plans to apply for Breakthrough Designation at the FDA to speed up the commercialization of PRO 140 for this clinical indication. PRO 140 is safe, highly tolerated, and exhibits negligible toxicities. It is these factors that make it a potential GvHD treatment.
CytoDyn Inc (OTCMKTS:CYDY) closed the day at $0.500 gaining 1.83%, exchanging 203,260 shares in yesterday’s trading session.
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