CytoDyn Submits Protocol to FDA for Phase 2b Clinical Study of PRO 140 for Treatment Substitution in Patients with HIV
February 18 2014 - 8:05AM
Business Wire
-PRO 140 has potential to be the key to
successful treatment substitution therapy-
CytoDyn 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 has submitted a Phase 2b clinical trial protocol, for its
lead product candidate, PRO 140, to the U.S. Food and Drug
Administration for treatment substitution 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. In this Phase 2b study, the Company’s primary objective is
to assess the efficacy of PRO 140 monotherapy for the maintenance
of viral suppression in HIV patients who are stable on combination
antiretroviral therapy, known as HAART (highly active
antiretroviral therapy), but need or wish to discontinue HAART
therapy temporarily.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive
Officer, stated, “We believe our treatment substitution study has
the potential to provide a drug holiday to patients from their
daily pill regimen. PRO 140 could be the key to maintaining viral
load suppression during a drug holiday. If the study has a positive
outcome, we believe this may address a significant unmet medical
need and have high patient acceptance.”
David Feigal, M.D., CytoDyn’s Chief Medical Officer, commented,
“We are entering an important phase with our plans for
advancing the development of PRO 140. I am excited to be leading
the clinical development of PRO 140 and look forward to exploring
its utility in treatment substitution. Importantly, I believe
we are another step closer to bringing the first antibody for the
treatment of HIV to the market.”
Dr. Feigal added, “The FDA recently approved the study drug
manufacturing and quality (CMC) of PRO 140 in connection with use
in other clinical trials. While we await receipt of FDA comments on
our treatment substitution protocol, we are working on selecting
study sites and preparing to launch patient screening and
enrollment for the study.”
Dr. Pourhassan concluded, “I am energized by our prospects of
further unlocking the potential of PRO 140 and believe the
treatment substitution indication has the potential not only to
address patient needs but also to advance CytoDyn to our next phase
of development. Our priorities are clear, and our team is committed
to aggressively advancing PRO 140 with the goal of providing
ground-breaking advancements in the treatment of HIV.”
About PRO 140
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, leading to potentially fewer side effects and
less frequent dosing requirements as compared to daily drug
therapies currently in use.
About CytoDyn
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 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;
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.
Investors and MediaJenene Thomas Communications,
LLCJenene Thomas, 908-938-1475Investor Relations and Corporate
Communications Advisorjthomas@cytodyn.com
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