10 October 2017
Amarex Clinical Research Announces Successful Orphan Drug Designation Request Filing
Germantown, MD, USA - Amarex is pleased to announce that it recently received notification from the U.S. Food and Drug Administration (FDA) that an orphan drug designation request, which it filed on behalf of CytoDyn Inc, has been granted. The product in question, PRO 140, is under development to prevent graft versus host disease (GvHD) in leukemia patients who have received bone marrow transplants. The granting of orphan status will provide CytoDyn with certain benefits, such as seven years of exclusivity for PRO140 on the US market, if the FDA approves the product for the intended indication.
Dr. Kazem Kazempour, President and CEO of Amarex, stated: "Amarex is pleased to have supported CytoDyn in obtaining this designation on their behalf. We congratulate CytoDyn on the granting of the request, and look forward to the continued development of this product."
Dr. Nader Pourhassan, President and CEO of CytoDyn, said: "We at CytoDyn are grateful to the FDA for approving this request in our efforts to provide treatment for this population in need. PRO140 targets and masks the CCR5 receptor on T cells, which is an important mediator of inflammatory diseases like GvHD."
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications and Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients' products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.
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 indications where CCR5 and its ligand CCL5 may be involved. For more information on the Company, please visit http://www.cytodyn.com.
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