US-based biotechnology firm CytoDyn has signed an agreement with Amarex Clinical Research for preparation of two Phase IIb clinical trial protocols as part of its expansion of clinical development programme for its lead product candidate PRO 140.
The two trial protocols will explore two additional therapeutic indications for PRO 140, a viral-entry inhibitor that is intended to protect healthy cells from viral infection.
According to the company, one of the new protocols is scheduled to be complete in the first quarter of 2014, with the second due for the second quarter of 2014.
Following submission of the Phase IIb clinical trial protocols to the US Food and Drug Administration (FDA), the company and Amarex will work with the FDA to get approval to start the clinical trials.
Amarex provides complete clinical product development services to pharmaceutical firms to achieve FDA approval for their new medical products, 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.
CytoDyn president and chief executive officer Nader Pourhassan said since the acquisition of PRO 140, the company concentrated its efforts on advancing the development programmes that had already been put in place.
"More recently, in collaboration with our scientific advisory board, David Feigal, MD, our chief medical officer, and his team have been working to identify the best clinical development pathways for PRO 140," Pourhassan said.
"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."
PRO 140 is a humanised monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.
The new drug candidate belongs to a new class of HIV/AIDS therapeutics that are intended to protect healthy cells from viral infection.
The product candidate, which was designated a ‘fast track’ status by the FDA, has been the subject of four Phase I/Ib and two Phase IIa clinical trials, each of which showed PRO 140’s ability to reduce HIV viral load in human test subjects.
Image: PRO 140 belongs to a new class of HIV/AIDS therapeutics. Photo: courtesy of freedigitalphotos.net.