CytoDyn Submits Phase IIb Protocol for PRO 140 Clinical Trial to FDA

  CytoDyn Submits Phase IIb Protocol for PRO 140 Clinical Trial to FDA

Business Wire

VANCOUVER, Wash. -- October 30, 2013

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 www.cytodyn.com.

Forward-Looking Statements

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.

Contact:

CytoDyn Inc.
Nader Pourhassan, Ph.D., 360-980-8524
 
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