CytoDyn Announces Important Milestone Achieved to Initiate Phase IIb Studies
CytoDyn Announces Important Milestone Achieved to Initiate Phase IIb Studies
PORTLAND, Ore.--(BUSINESS WIRE)-- CytoDyn Inc. ("CytoDyn") (OTC QB: CYDY), a biotechnology company focused on the development of new therapies for the treatment of human immunodeficiency virus (HIV) infection, announced that CytoDyn Inc. and Drexel University have entered into a contract with Ajinomoto Althea, Inc. to formulate CytoDyn's PRO 140 bulk drug substance through a "fill and finish" process resulting in clinical-ready vials to advance its two NIH-funded Phase IIb studies. These trials will be conducted by Drexel University and are funded by over $10 million in grants from the National Institute of Health (NIH). Ajinomoto Althea, Inc. is a contract development and manufacturing company based in San Diego, California.
PRO 140 was designated a FDA Fast Track drug candidate by the U.S. Food and Drug Administration (FDA) for the treatment of human immunodeficiency virus (HIV) infection. The FDA Fast Track Development Program facilitates development and expedites regulatory review of drugs intended to address an unmet medical need for serious or life-threatening conditions. PRO 140 belongs to a new class of HIV/AIDS therapeutics -- viral-entry inhibitors -- that are intended to protect healthy cells from viral infection. PRO 140 is a humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.
"CytoDyn acquired PRO 140 in October 2012 and is getting PRO 140 back on the right track in the development process despite a three year delay in starting Phase IIb trials. This is very exciting for the management team and all of our shareholders," stated Dr. Nader Pourhassan, CytoDyn's President and CEO. "In advance of these trials, we have also engaged several expert manufacturing and clinical trial consultants to assist in our efforts as PRO 140 progresses toward clinical trials. We are confident that the new members of our team will enable us to initiate the Phase IIb trials without further delay. With this agreement and our "fill and finish" plan in place, we expect to start enrolling patients by the fourth quarter of this year," added Dr. Pourhassan.
"I am very pleased to see PRO 140 advance as an HIV therapy candidate," said Dr. Jeffrey M. Jacobson, the Professor of Infectious Disease and HIV specialist at Drexel University College of Medicine who oversaw PRO 140's initial trial development.
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 HIV and FIV. The Company currently has two mAbs under development for HIV infection. PRO 140, recently acquired from Progenics Pharmaceuticals, is a Late Stage II humanized mAb with demonstrated antiviral activity in man.
PRO 140 blocks the Human Immunodeficiency Virus (HIV) co-receptor CCR5 without affecting the normal function of the molecule. 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. The Company's second humanized mAb under development is Cytolin®, which targets LFA-1, a membrane-associated molecule reported to be important for entry and fusion of HIV to target cells and for cell-to-cell transmission. CytoDyn is also exploring the possibility that its anti-LFA-1 strategy to control HIV infection may be effective to treat feline immunodeficiency virus (FIV) infection, as well. To test this hypothesis, CytoDyn is developing CytoFeline, a monoclonal antibody that blocks feline LFA-1. 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, of which many are 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 our 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 our products and product candidates will be unfavorable; our 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 our products; CytoDyn, our 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.
We are also subject to additional risks and uncertainties, including risks associated with the actions of our 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 our products may be invalid, unenforceable or challenged, or fail to provide adequate market exclusivity. There are also substantial risks arising out of our need to raise additional capital to develop our products and satisfy our financial obligations; the highly regulated nature of our business, including government cost-containment initiatives and restrictions on third-party payments for our products; the highly competitive nature of our industry; and other factors set forth in our Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission.
About Ajinomoto Althea, Inc.
Ajinomoto Althea is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Ajinomoto Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Ajinomoto Althea offers comprehensive development services including: upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release and ICH-compliant stability testing. Ajinomoto Althea's formulation technology platform includes Crystalomics®, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations. For more information, visit www.altheatech.com.
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