CytoDyn Inks Agreement with Amarex Clinical Research to Prepare Two Phase 2b Clinical Trial Protocols to Explore Two Additional Therapeutic Indications for PRO 140
CytoDyn, a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced that the Company plans to expand its clinical development program for PRO 140 and signed an agreement with Amarex Clinical Research to prepare two Phase 2b clinical trial protocols to explore two additional therapeutic indications for its lead product candidate.
According to a release, one of the new protocols is expected to be completed in the first quarter of 2014 and the second protocol early in the second quarter of 2014. After submission of the Phase 2b clinical trial protocols to the U.S. Food and Drug Administration (FDA), the Company and Amarex will work with the FDA to obtain approval to commence the trials.
CytoDyn noted that Amarex is a global Contract Research Organization (CRO) that provides complete clinical product development services to pharmaceutical companies to achieve FDA approval for their new medical products. Amarex has expertise in product development plan creation, product safety and efficacy testing, and applications to the FDA for marketing approval of new or improved medical products.
Nader Pourhassan, Ph.D., CytoDyn's President and Chief Executive Officer, stated, "Since we acquired PRO 140, we had concentrated our efforts on advancing the development programs that had already been put in place. More recently, in collaboration with our Scientific Advisory Board, David Feigal, M.D., our Chief Medical Officer, and his team have been working to identify the best clinical development pathways for PRO 140. We believe we have identified two new indications that may lead to an opportunity for PRO 140 to address areas of significant unmet need for physicians and patients and, ultimately, generate significant shareholder value."
Dr. Feigal commented, "I am excited we have the opportunity to expand the clinical development program for PRO 140 and very pleased to be working closely with Amarex in developing and finalizing protocols for two new indications. We have specifically chosen to work with Amarex to prepare and finalize these important clinical trial protocols for CytoDyn as we firmly believe their expertise and proven track record with the FDA is perfectly aligned with our clinical development strategy and priorities for PRO 140."
Kazem Kazempour, Ph.D., Amarex's President and Chief Executive Officer, said, "Amarex is very pleased to have the opportunity to support CytoDyn in the development of PRO 140. We believe our extensive experience in clinical trial management, HIV-related research, and parallel processing of trial services, will enable CytoDyn to complete these trials as quickly as possible, and with the greatest chance of success."
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