LUTZ, Fla.--(BUSINESS WIRE)--
CytoDyn Inc. (the "Company")(OTCQB:CYDY), a biotechnology company
focused on the development of new therapies for combating infection with
immune deficiency virus and other antibody applications, announced today
that the Company completed production of a sufficient amount of
CytoFeline?, a monoclonal antibody developed by the Company for the
treatment of Feline Immunodeficiency Virus ("FIV"), to allow the
Company, through its wholly owned subsidiary, CytoDyn Veterinary
Medicine LLC ("CVM"), to move forward with the next stage of the
antibody's development. When purification of the antibody is completed,
CVM will conduct in vivo efficacy tests in cats to determine the
practicality of anti-LFA1 antibodies to lower viral loads in
FIV-infected cats.
CVM has selected Colorado State University and Dr. Susan VandeWoude,
DVM, Associate Dean for Research CVMBS, Professor of Comparative
Medicine, DMIP, at Colorado State University to lead the CVM's
continuing research of CytoFeline?, and to conduct these additional
efficacy tests. "CytoFeline? potentially represents an exciting new
anti-retroviral therapy for cats with FIV. We will be testing its
potential to be used in cats infected with FIV, and hope that our
studies will provide a new therapeutic option for cats suffering from
this disease," commented Dr. VandeWoude.
Initial CytoFeline? research was performed in the laboratory of Dr. John
Elder, Ph.D, Professor in the Department of Immunology and Microbial
Science at The Scripps Research Institute. The Company anticipates that
Dr. Elder intends to publish a paper discussing the results of his
research when the research is completed.
"CVM looks forward to being able to commence the next stage of research
of CytoFeline?, and to continue to explore the FIV model as a potential
stand-alone business opportunity," commented Kenneth J. Van Ness,
President and Chief Executive Officer of the Company.
Forward Looking Statements
The Press Release includes forward-looking statements and includes
forward-looking information within the meaning of United States
securities laws. These statements and this information represent the
Company's intentions, plans, expectations and beliefs, and are subject
to risks, uncertainties and other factors, of which many are beyond the
Company's control. These factors could cause actual results to differ
materially from such forward-looking statements or forward-looking
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. The Company 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 on this 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; the Company's products will not
receive marketing approval from regulators or, if approved, do not gain
sufficient market acceptance to justify development and
commercialization costs; competing products currently on the market or
in development might reduce the commercial potential of the Company's
products; the Company, its collaborators or others might identify side
effects after the product is on the market; or efficacy or safety
concerns regarding marketed products, whether or not originating from
subsequent testing or other activities by the Company, governmental
regulators, other entities or organizations or otherwise, and 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.
The Company is also subject to risks and uncertainties associated with
the actions of its corporate, academic and other collaborators and
government regulatory agencies, including risks from market forces and
trends; potential product liability, intellectual property, litigation,
environmental and other risks, the risk that the Company may not be able
to enter into favorable collaboration or other relationships or that
existing or future relationships may not proceed as planned, the risk
that current and pending patent protection for the Company's products
may be invalid, unenforceable or challenged, or fail to provide adequate
market exclusivity, and the uncertainty of the Company's future
profitability.
Risks and uncertainties also include general economic conditions,
including the availability of capital; changes in generally accepted
accounting principles; the impact of legislation and regulatory
compliance; the highly regulated nature of the Company's business,
including government cost-containment initiatives and restrictions on
third-party payments for the Company's products; trade buying patterns;
the competitive climate of the Company's industry; and other factors set
forth in the Company's Annual Report on Form 10-K and other reports
filed with the U.S. Securities and Exchange Commission. In particular,
the Company cannot assure you that Cytolin® or CytoFeline?
will be commercially successful or be approved in the future in other
formulations, indications or jurisdictions, or that any of the Company's
other programs will result in a commercial product.
For more information about Cytolin®, CytoFeline? and the
Company please go to www.cytodyn.com.
