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.
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 www.cytodyn.com.
This press release includes forward-looking statements and forward-looking information within the meaning of United States securities laws. These statements and information represent CytoDyn’s intentions plans expectations and beliefs and are subject to risks uncertainties and other factors many beyond CytoDyn’s control. These factors could cause actual results to differ materially from such forward-looking statements or information. The words “believe” “estimate” “expect” “intend” “attempt” “anticipate” “foresee” “plan” and similar expressions and variations thereof identify certain of such forward-looking statements or forward-looking information which speak only as of the date on which they are made.
CytoDyn disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information whether as a result of new information future events or otherwise except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or forward-looking information. While it is impossible to identify or predict all such matters these differences may result from among other things the inherent uncertainty of the timing and success of and expense associated with research development regulatory approval and commercialization of CytoDyn’s products and product candidates including the risks that clinical trials will not commence or proceed as planned; products appearing promising in early trials will not demonstrate efficacy or safety in larger-scale trials; future clinical trial data on CytoDyn’s products and product candidates will be unfavorable; CytoDyn’s products will not receive marketing approval from regulators or if approved fail to gain sufficient market acceptance to justify development and commercialization costs; competing products currently on the market or in development may reduce the commercial potential of CytoDyn’s products; CytoDyn its collaborators or others may identify side effects after the product is on the market; or efficacy or safety concerns regarding marketed products whether or not scientifically justified may lead to product recalls withdrawals of marketing approval reformulation of the product additional pre-clinical testing or clinical trials changes in labeling of the product the need for additional marketing applications or other adverse events.
CytoDyn is also subject to additional risks and uncertainties including risks associated with the actions of its corporate academic and other collaborators and government regulatory agencies; risks from market forces and trends; potential product liability; intellectual property litigation environmental and other risks; and risks that current and pending patent protection for its products may be invalid unenforceable or challenged or fail to provide adequate market exclusivity. There are also substantial risks arising out of CytoDyn’s need to raise additional capital to develop its products and satisfy its financial obligations; the highly regulated nature of its business including government cost-containment initiatives and restrictions on third-party payments for its products; the highly competitive nature of its industry; and other factors set forth in CytoDyn’s Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission.