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CytoDyn Submits Phase IIb Protocol for PRO 140 Clinical Trial to FDA
  CytoDyn Inc., a Vancouver, Wash.-based biotech company, raised $14.5 million from a private offering, helping fund its ongoing efforts to develop HIV treatments.
The proceeds will be used to fund current operating expenses and continue development of its primary drug candidate, PRO 140, believed to be one of the leading monoclonal antibodies for treatment of HIV.
"CytoDyn is now well positioned to advance PRO 140 as a leading HIV-therapy candidate and to achieve our milestones as we progress into our upcoming clinical trials," Dr. Nader Pourhassan, CytoDyn's president and CEO, said in a statement.
"PRO 140 is an "entry inhibitor" that blocks HIV from entering and infecting certain cells. It has gone through two clinical trials, each of which showed a reduction in HIV viral load in humans. It has also been designated as a fast track product candidate by the FDA.
The PRO 140 antibody appears to be a powerful antiviral agent, with fewer side effects and less frequent dosing, as compared to daily drug therapies now in use, according to CytoDyn. The company plans to use grant funding for further clinical trials this quarter."
VANCOUVER, Wash., Oct 30, 2013 (BUSINESS WIRE) -- CytoDyn Inc. ("CytoDyn") (otcqb:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, today announced that CytoDyn Chief Medical Officer David Feigal, M.D., has submitted a revised protocol to the U.S. Food and Drug Administration relating to an upcoming Phase IIb clinical trial of PRO 140, CytoDyn's leading product under development as a treatment for Human Immunodeficiency Virus (HIV) infection. The submission was for protocol 2102 titled, "Randomized, Double-blind, Placebo-controlled Clinical Trial of Observed Systemic, Long-acting, Anti-HIV treatment with a Monoclonal CCR5 antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Recreational Drug Users with Viral Rebound and Poor Adherence to the Previous Antiretroviral Regimen." Drexel University College of Medicine has received a grant from the National Institutes of Health to fund this clinical trial.
Prior to CytoDyn's acquisition of PRO 140 from Progenics Pharmaceuticals, Inc., in October 2012, initial screening at study sites had commenced under Protocol 2102, but Progenics halted the study for strategic business reasons. Current plans call for opening the study for enrollment before the end of 2013. "This continues to be a very exciting year for the Company," said CytoDyn President and CEO Dr. Nader Pourhassan. "We have completed the 'fill and finish' process for our PRO 140 bulk drug product and placebo. The vials are now available for use in our clinical trials," he added.
The Company
CytoDyn is a biotechnology company focused on developing subcutaneously delivered humanized cell-specific monoclonal antibodies (mAbs) as entry inhibitors for the treatment and prevention of Human Immunodeficiency Virus (HIV). The Company has one of the leading mAbs under development for HIV infection, PRO 140, which is a Late Stage II humanized mAb with demonstrated antiviral activity in man. PRO 140 blocks the HIV co-receptor CCR5 and clinical trial results thus far indicate that it does not affect the normal function of the cell. Results from Phase I and Phase IIa human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV. For more information on the Company, please visit
SOURCE: CytoDyn Inc.
CytoDyn Inc. Appoints David Feigal, M.D., as Chief Medical Officer
CytoDyn Inc. ("CytoDyn") (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses announced the appointment of Dr. David Feigal as the Company's new Chief Medical Officer.
Dr. David Feigal, M.D. spent 12 years with the U.S. Food & Drug Administration (FDA) where he served as Director Center for Devices & Radiological Health (CDRH) Director Division of Anti-infective & Antiviral Drug Products Center for Drug Evaluation & Research (CDER) and Deputy Director Center for Biologics Evaluation & Research (CBER). He is former Vice President of Global Regulatory Strategy Amgen and former Senior Vice President Head of Global Regulatory and Global Safety Surveillance at Elan Corporation. Dr. Feigal has more than 30 years of experience in drug development and regulation. Before joining the FDA he worked for 10 years within the academic and hospital settings of the University of California in San Diego San Francisco and Davis.
Dr. Feigal is a Partner in NDA Partners. CytoDyn has engaged NDA Partners and Amarex Clinical Research to manage and oversee the clinical development needs for the Company's primary product PRO 140 a leading monoclonal antibody for the treatment of HIV.
"After careful review of PRO 140 we believe PRO 140 is an exciting product and we are pleased with the unique opportunity to assist with its future development" said Dr. Feigal. "NDA Partners and I are ready to manage all the clinical trials needs for PRO 140 as we progress to this next important phase. The vast FDA experience within NDA Partners will provide valuable resources through the upcoming clinical trials and beyond."
Dr. Nader Pourhassan CytoDyn's President and CEO stated "We are very fortunate to have Dr. Feigal serve as the Company's CMO bringing the world class talent we need to lead our product through the next critical phase of this important project. The opportunities for PRO 140 as a leading monoclonal antibody for HIV treatment are attracting the attention of leaders in the scientific community." PRO 140 belongs to a class of entry inhibitors that block HIV from entering and infecting certain cells. PRO 140 has been the subject of one Phase I and two Phase IIa clinical trials each of which demonstrated PRO 140's ability to significantly reduce HIV viral load in human test subjects and has also been designated a "fast track" product candidate by the United States Food and Drug Administration. The PRO 140 antibody appears to be a powerful antiviral agent while not being a drug leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use. The Company previously announced its plans to commence clinical trials in the fourth quarter of 2013 which collectively are expected to constitute a Phase IIb trial and will be funded by two grants from the National Institutes of Health to Drexel University College of Medicine.

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