|[March 19, 2014]
CytoDyn Announces Investor Call to Provide Update on Clinical Development Strategy
VANCOUVER, Wash. --(Business Wire)--
Inc. (OTCQB: CYDY), a biotechnology company focused on
the development of new therapies for combating infection with immune
deficiency viruses, announced today that the Company will host a live
conference call and webcast with the investment community on Tuesday,
March 25, 2014 at 1:30 p.m. PT to provide an update on the Company's
clinical development strategy for lead product candidate, PRO
140, including progress with its preparations for its treatment
substitution Phase 2b study in patients with Human Immunodeficiency
Virus (HIV). PRO 140 is a humanized monoclonal antibody directed against
CCR5, a molecular portal that HIV uses to enter cells, and belongs to a
class of HIV therapies known as entry inhibitors that block HIV from
entering into and infecting certain cells.
Conference Call and Webcast Instructions
CytoDyn's management team will host a conference call and live audio
webcast on Tuesday, March 25, 2014 at 1:30 p.m. PT.
Interested participants and investors may access this conference call by
dialing 877-407-2986 (U.S./Canada) or 201-378-4916 (international).
A live audio webcast may also be accessed via the Investors section of
CytoDyn's corporate web site at www.cytodyn.com,
and will be archived for 30 days. Web participants are encouraged to go
to the web site 15 minutes prior to the start of the call to register,
download and install any necessary software.
A replay of the conference call will be available until April 1, 2014.
To access the replay, interested parties may dial 877-660-6853
(U.S./Canada) or 201-612-7415 (International); Conference ID: 13578723.
About 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.
PRO 140 has been the subject of four Phase 1/1b and two Phase 2a
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 FDA. The PRO 140
antibody appears to be a powerful antiviral agent while not being a
drug, potentially leading to fewer side effects and less frequent dosing
requirements as compared to daily drug therapies currently in use.
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 2 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 1/1b
and Phase 2a 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
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; funding for
additional clinical trials may not be available; CytoDyn's products may
not receive marketing approval from regulators or, if approved, may 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 Quarterly Report
on Form 10-Q for the quarter ended November 30, 2013 and other reports
filed with the U.S. Securities and Exchange Commission.
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