Biotechnology company CytoDyn Inc. (OTCQB: CYDY) this morning detailed its plan to develop PRO 140 (leronlimab) as a therapy for metastatic triple-negative breast cancer. Per the update, previously announced findings from preclinical studies showed the ability of PRO 140 to block human breast cancer cellular invasion in a surrogate assay for metastatic breast cancer. “We plan to aggressively pursue the development of PRO 140 as a therapy for women with metastatic triple-negative breast cancer, which is in keeping with our strategy to evaluate PRO 140 in certain cancers and immunological indications where CCR5 antagonism has shown initial promise,” Nader Pourhassan, Ph.D., president and CEO of CytoDyn, stated in the news release. “In addition, we are continuing to move forward with plans to assess PRO 140 in metastatic colon cancer… We are pleased with our recent progress toward filing a Biologics License Application (BLA) for PRO 140 as a combination therapy for HIV and are confident that two thirds of our BLA submission will be completed by the end of 2018 and the last section, Chemistry, Manufacturing and Controls (CMC), by first quarter of 2019.”
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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 humans and is currently in Phase 3 development. 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, inflammatory indications where CCR5 and its ligand CCL5 may be involved. For more information, visit the company’s website at www.CytoDyn.com
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