CytoDyn Signs Agreement with Amarex Clinical Research LLC to Prepare Two Phase 2b Clinical Trial Protocols to Explore Two Add...
January 28 2014 - 08:05AM
Business Wire
Company plans to expand clinical development
program for lead product candidate
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
plans to expand its clinical development program for PRO 140 and
signed an agreement with Amarex Clinical Research LLC to prepare
two Phase 2b clinical trial protocols to explore two additional
therapeutic indications for its lead product candidate. One of the
new protocols is expected to be completed in the first quarter of
2014 and the second protocol early in the second quarter of 2014.
After submission of the Phase 2b clinical trial protocols to the
U.S. Food and Drug Administration (FDA), the Company and Amarex
will work with the FDA to obtain approval to commence the
trials.
Amarex is a global Contract Research Organization (CRO) that
provides complete clinical product development services to
pharmaceutical companies to achieve FDA approval for their new
medical products. Amarex has expertise in product development plan
creation, product safety and efficacy testing, and applications to
the FDA for marketing approval of new or improved medical
products.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive
Officer, stated, “Since we acquired PRO 140, we had concentrated
our efforts on advancing the development programs that had already
been put in place. More recently, in collaboration with our
Scientific Advisory Board, David Feigal, M.D., our Chief Medical
Officer, and his team have been working to identify the best
clinical development pathways for PRO 140. We believe we have
identified two new indications that may lead to an opportunity for
PRO 140 to address areas of significant unmet need for physicians
and patients and, ultimately, generate significant shareholder
value.”
Dr. Feigal commented, “I am excited we have the opportunity to
expand the clinical development program for PRO 140 and very
pleased to be working closely with Amarex in developing and
finalizing protocols for two new indications. We have specifically
chosen to work with Amarex to prepare and finalize these important
clinical trial protocols for CytoDyn as we firmly believe their
expertise and proven track record with the FDA is perfectly aligned
with our clinical development strategy and priorities for PRO
140.”
Kazem Kazempour, Ph.D., Amarex’s President and Chief Executive
Officer, said, “Amarex is very pleased to have the opportunity to
support CytoDyn in the development of PRO 140. We believe our
extensive experience in clinical trial management, HIV-related
research, and parallel processing of trial services, will enable
CytoDyn to complete these trials as quickly as possible, and with
the greatest chance of success.”
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
Annual Report on Form 10-K 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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