CytoDyn Appoints Denis R. Burger, Ph.D. to Board of Directors
February 13 2014 - 8:05AM
Business Wire
Industry veteran with proven track record in
HIV drug development bolsters board with scientific, operational
and financial expertise
CytoDyn Inc. (OTCQB: CYDY), a biotechnology
company focused on the development of new therapies for combating
infection with immune deficiency viruses, announced the appointment
of Denis R. Burger, Ph.D. to its Board of Directors effective
February 7, 2014. Dr. Burger is a life sciences executive with over
25 years of extensive scientific, operational and financial
experience in the biotech industry.
As CEO or chairman of several biotechnology companies, Dr.
Burger has led numerous corporate financing transactions and public
securities offerings and has experience leading R&D, GMP
manufacturing and clinical development functional areas.
Additionally, he holds a patent for a method of detecting AIDS
virus infection and oversaw the development of the first monoclonal
antibody approved by the FDA for clinical use. Dr. Burger joins
CytoDyn’s board as the Company prepares to advance the clinical
development of PRO 140, a leading monoclonal antibody for the
treatment of HIV.
“We are very pleased to welcome Dr. Burger to the CytoDyn Board
of Directors during this important time. His scientific and
industry expertise, business acumen and experience in leading
successful biotech companies will prove to be invaluable to the
Company,” said Anthony D. Caracciolo, CytoDyn’s Chairman of the
Board.
Dr. Burger commented, “The CytoDyn management team and board of
directors have identified a clear, strategic path for its
first-in-class, viral entry inhibitor product candidate, PRO 140. I
am excited to join CytoDyn’s board of directors and truly believe
PRO 140 has the potential to change the treatment paradigm for
patients with HIV/AIDS.”
Dr. Burger is currently a director of Lorus Therapeutics, Inc.,
a cancer therapeutics, TSX-listed company. Dr. Burger co-founded
Trinity Biotech, a NASDAQ-listed diagnostic company, in June 1992,
served as its Chairman from June 1992 to May 1995, and is currently
lead independent director. Until March 2007, he was Chairman and
Chief Executive Officer of AVI Biopharma Inc. (now Sarepta
Therapeutics), a NASDAQ-listed RNA therapeutics company. He was
also a co-founder of Epitope Inc. (now Orasure Technologies,
NASDAQ-listed), serving as its Chairman from 1981 to 1990. Dr.
Burger previously held a professorship in the Department of
Microbiology and Immunology and Surgery (Surgical Oncology) at the
Oregon Health and Sciences University in Portland. Dr. Burger
received his undergraduate degree in Bacteriology and Immunology
from the University of California in Berkeley and his Master of
Science and Ph.D. degrees in Microbiology and Immunology from the
University of Arizona.
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 Media:Jenene Thomas Communications, LLCJenene
Thomas, 908-938-1475Investor Relations and Corporate Communications
Advisorjthomas@cytodyn.com
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