Biotechnology company CytoDyn Inc. (OTCQB: CYDY) this morning announced the treatment of the first patient in its phase 2 clinical trial of PRO 140 for Graft versus Host Disease (GvHD), which represents its leading immunologic indication for the candidate. The multicenter, 60-patient study aims to evaluate the safety and efficacy of PRO 140 in treating GvHD, a potentially life-threatening complication affecting patients requiring a bone marrow transplant due to depleted immune systems. Currently, these transplant patients have just a 40-60% one-year survival rate, and relapsed GvHD is the leading cause of death. “We 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,” Denis R. Burger, Ph.D., chief science officer of CytoDyn, stated in the news release. “We 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 the company receives positive results from its phase 2 study evaluating PRO 140 for the treatment of GvHD, CytoDyn expects to file for Breakthrough Designation with the FDA in order to expedite the commercialization of its lead candidate in this clinical indication.
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CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed phase 2 clinical trials with demonstrated antiviral activity in man and is currently in phase 3. PRO 140 blocks the HIV co-receptor CCR5 on T cells, which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from seven phase 1 and phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several months of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV indications where CCR5 and its ligand CCL5 may be involved. For more information on the company, please visit www.CytoDyn.com.
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