CytoDyn Transfers Research on Novel AIDS Drug to Massachusetts General Hospital

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Thu Oct 8, 2009 9:00am EDT

SANTA FE, N.M.--(Business Wire)--
In response to new economic and regulatory realities, CytoDyn, Inc. (Pink
Sheets:CYDY) has made a sea change in its strategy for developing Cytolin, the
Company`s unique immune therapy for treating HIV/AIDS. Studies of the drug will
be designed and conducted by Massachusetts General Hospital, one of the premier
teaching hospitals in Boston, Massachusetts, as part of its mission to advance
medical knowledge and treatments through research, education and patient care. 

The Current Standard for Treating HIV/AIDS

During the past decade, significant improvements in the antiviral "cocktails"
used to treat HIV/AIDS have transformed this once fatal disease into a chronic,
manageable condition. Many such antiviral drugs are available, including
Atripla, which combines drugs from Bristol-Myers Squibb (NYSE:BMY) and Gilead
Sciences (NasdaqGS:GILD); Viracept from Pfizer (NYSE:PFE); and Norvir from
Abbott Laboratories (NYSE:ABT), to name but a few. These drugs are the
ingredients of Highly Active Antiretroviral Therapy (HAART), which has saved
countless lives and is well tolerated by most patients, although all drugs have
side effects. 

The current standard of treatment recommends withholding antiviral drugs until
the disease has progressed to the point where the drugs are required to maintain
a patient`s health, typically a period of about five years from initial
infection. A chief reason for withholding treatment during the early years of
HIV infection is that antiviral drugs attack the virus directly. As a result,
natural selection promotes the evolution of HIV into species that are resistant
to those drugs. If antiviral drugs were prescribed too early, then the virus
might become resistant to those drugs, rendering them ineffective, by the time
they were necessary to maintain a patient`s health. 

About Cytolin

Cytolin is a monoclonal antibody administered by intravenous infusion and might
expand the standard of treatment. In preliminary clinical trials, and in
compassionate use involving hundreds of patients treated for about two years,
Cytolin produced encouraging results in delaying or reversing disease
progression while acquiring a good safety record. 

Significantly, Cytolin is not an antiviral drug although it has a significant,
albeit indirect, antiviral effect (log reduction in viral burden). A
first-in-class drug, Cytolin is designed to prevent the wholesale destruction of
helpful CD4 T cells by a person`s own killer T cells. The killer T cells are
made by the human body in response to HIV infection as part of the natural
defense against the virus. As first shown by Zarling, et al in 1990 (Journal of
Immunology, vol. 144, page 2992), the ability of these killer T cells to
indiscriminately destroy CD4 T cells is a trait unique to humans, explaining why
HIV infection does not cause disease in the other species the virus can infect.
It has been known since the beginning of the AIDS pandemic that a wholesale loss
of CD4 T cells is the reason why individuals infected with HIV become
susceptible to the opportunistic infections and cancers that characterize AIDS.
Up until the 1990s when three independent studies identified the killer T cells
as the cause of the problem, the reason for the wholesale loss of CD4 cells
remained a mystery because the virus infects relatively few CD4 T cells. 

The fact that Cytolin has no direct effect on the life-cycle of the virus
precludes the emergence of Cytolin-resistant virus due to the long-term use of
Cytolin. This is in contrast to the antiviral drugs whose use promotes the
evolution of drug-resistant virus. Consequently, a potential indication for
Cytolin would be to administer it early in the infection in order to delay the
natural progression of the disease and, therefore, the time when antiviral drugs
become necessary. If so, healthcare providers could treat individuals infected
with HIV more quickly, rather than spending years just watching and waiting. 

Cytolin is the brainchild of scientist Allen D. Allen, the CEO of CytoDyn, which
has been developing Cytolin as its lead product since the Company`s inception in
2003. Notwithstanding CytoDyn`s previous public discussions and efforts centered
on other potential indications, the Company is now committed to developing
Cytolin for the above indication; that is, as a monotherapy for treating early
HIV infection before the antiviral drugs are indicated. The Company believes
this best serves the needs of those infected with HIV and the physicians who
treat them. 

About The Study

CytoDyn has agreed to provide a research grant and cGMP product to Massachusetts
General Hospital for the purpose of conducting an ex-vivo study of Cytolin. The
study will enroll 10 adults with early HIV infection and 10 healthy controls,
each of whom will be required to participate for six months. This study is
intended as a prelude to an in vivo study and will take advantage of the
facilities available at Massachusetts General Hospital to confirm, and perhaps
sharpen, the role of killer T cells in causing the wholesale loss of CD4 T
cells, as well as the mechanisms of action responsible for the clinical benefits
observed in patients treated with Cytolin, including the roles played by various
cytokines and cluster determinants (the "CD" used to categorize lymphocytes,
such as "CD4 T cells"). 

The Company is pleased to report that the Principal Investigator is Eric S.
Rosenberg, MD, an Associate Professor of Medicine in the Infectious Diseases
Division of Massachusetts General Hospital and a prominent researcher
specializing in HIV/AIDS. More than the Principal Investigator, Dr. Rosenberg
designed the protocol for the study after an extensive review of the relevant
literature and human experience related to Cytolin. His review was aided by a
comprehensive due diligence report kindly prepared by David Scondras, a
Boston-based AIDS activist. 

Risks of Academic Research

Massachusetts General Hospital is a nonprofit, tax-exempt facility with the
mission of improving the public health by engaging in research for the purpose
of discovering and making available to the public new and improved medical
treatments and information. As a consequence, Massachusetts General Hospital
does not conduct studies unless its researchers are free to publish the study
results as, how, and when they see fit, provided only that the trade secrets of
CytoDyn may not be disclosed. 

When researchers have such unrestricted freedom to publish, it can pose a risk
to the company developing a drug. This is because the outcome of clinical
research is uncertain and the results may differ significantly from the
expectations of the company and the researchers. However, CytoDyn`s management
believes this risk is minimal inasmuch as Cytolin has already been used to treat
hundreds of patients over extended periods of time. Consequently, the study is
unlikely to produce unexpected or surprising results that would call the safety
and efficacy of Cytolin into question. Nonetheless, the study may fail to meet
its objectives for any number of reasons. These include but are not limited to
the failure of in vivo events to manifest in vitro, enrollment of patients whose
HIV infection is still too early, and the failure of a sufficient number of
human subjects to complete the study. 

Other Uncertainties

This announcement contains statements that are not historic facts but anticipate
future events and circumstances. All such forward-looking statements made by the
Company are necessarily estimates based upon current information and projections
and involve a number of risks and uncertainties, including but not limited to,
the failure of preliminary results from clinical studies to reflect the results
from more comprehensive studies, and an inability to enroll a sufficient number
of patients or to otherwise complete a study. There can be no assurance that
such risks and uncertainties, or other factors, will not affect the accuracy of
such forward-looking statements. It is impossible to identify all the factors
that could cause actual results to differ materially from those estimated by
CytoDyn. They include, but are not limited to, government regulation, managing
and maintaining growth, victimization by white-collar offenders, and the effects
of adverse publicity, litigation, competition, and other factors that may be
identified from time to time in the Company`s announcements.

CytoDyn, Inc.
Corinne Allen, CFO
1-505-988-5520 

Copyright Business Wire 2009

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