Santa Fe, NM — July 26, 2010 — For the latest information on the clinical trial of Cytolin®, take your browser to http://clinicaltrials.gov and enter the word "Cytolin" in the search engine. The referenced website provides detailed information on all of the clinical trials being conducted in the United States and is a public service of the U.S. Department of Health and Human Services.
 

CytoDyn Welcomes Banker Kenneth J. Van Ness to its Board of Directors

Santa Fe, NM — June 17, 2010 — The Board of Directors of CytoDyn, Inc. (Pink Sheets: CYDY) has elected Kenneth J. Van Ness to the Board to fill a vacancy. Mr. Van Ness holds a substantial position in CytoDyn and is well versed on the Company’s opportunities and business plan. He received a BS degree from the University of Florida in 1973, and for the past quarter century has served national financial institutions and public companies with line, P&L, and divisional responsibilities. During the past decade, Mr. Van Ness has focused on his career as a merchant mortgage banker. CytoDyn believes that his knowledge of banking and publicly traded companies will make Mr. Van Ness a valuable addition to the Company’s Board of Directors.
 

CytoDyn Raises Three Million Dollars in Private Placements

Santa Fe, NM — March 31, 2010 — CytoDyn, Inc. (Pink Sheets: CYDY) has raised $3,000,000 in two private placements that were sold out on March 29, 2010. One placement offered the Company’s restricted common stock to a select group of accredited investors, while the other offered the Company’s convertible preferred shares to a broader range of accredited investors.

Historically, CytoDyn has used its funds to pay for the following:

1. Development of the Company’s lead product Cytolin®, a novel immune therapy for treating HIV/AIDS.
    
2. Maintaining and expanding the Company’s international patent portfolio.
    
3. Regulatory compliance.
    
4. General business operations.

CytoDyn Increases Study Budget to Accelerate Clinical Trial

Santa Fe, NM — March 22, 2010 — CytoDyn, Inc. (Pink Sheets:CYDY) has agreed to provide an additional $204,000 for the current clinical trial of Cytolin®, the Company’s novel immune therapy for treating HIV/AIDS. This will enable the Principal Investigator to hire additional personnel in order to ensure that key data from the study will be available by December 31, 2010.  For details about the clinical trial visit http://clinicaltrials.gov. and enter Cytolin as a search term.

CytoDyn Begins Full Humanization of Cytolin®

Santa Fe, NM — March 17, 2010 — CytoDyn, Inc. (Pink Sheets: CYDY) has begun full humanization of Cytolin®, the Company’s unique immune therapy for treating HIV/AIDS. Although a murine (mouse) version of Cytolin® was used for previous human experience that included some 200 patients successfully treated for up to two years, as well as an encouraging Phase I(b)/II(a) study, the Company believes that a fully-humanized version is necessary for the clinical trial that is expected to follow the current one (described at http://clinicaltrials.gov) for the reasons explained below.

Unlike the other monoclonal antibodies that have been approved for treating diseases such as cancer and rheumatoid arthritis, Cytolin® is not a “neutralizing” antibody, meaning it does not initiate phagocytosis, the process that removes unwanted substances and cells from the body. As a result, HAMA (Human Anti-Mouse Antibodies), which are a natural response to murine antibodies, did not block the therapeutic effect of Cytolin® during previous human experience, even though HAMA are known to have this effect on neutralizing antibodies, making some form of humanization mandatory for those other antibodies. To the contrary, there is some evidence that HAMA may have increased the length of time that Cytolin® remained bound to the targeted cytotoxic T cells that would otherwise have destroyed healthy CD4+ T cells, thereby increasing the duration of the therapeutic effect of Cytolin®. Since therapeutic antibodies usually cost thousands of dollars per treatment, a product that needs to be administered less often could provide a meaningful reduction in costs.

Nonetheless, the current study of Cytolin® anticipates its use in early HIV infection —before the antiviral drugs are used, in order to delay disease progression with a drug that cannot cause the virus to become resistant because it has no direct effect on the virus itself. When used for this purpose, Cytolin® needs to be well tolerated. Patients are often unwilling to endure any discomfort caused by a treatment when they are not yet suffering from the symptoms of a disease and are not in any immediate danger. As a well known example, the flu-like symptoms associated with interferon-alpha too often result in non-compliance on the part of patients with hepatitis.

According to prevailing theory, a fully-humanized version of Cytolin® will be even less likely than the murine version to cause the side effects sometimes seen when any protein is injected into the human blood stream. These side effects include serum sickness (flu like symptoms), protein sickness (brief lower back pain) and an allergic reaction which, rarely, can be life-threatening if not promptly treated.

CytoDyn expects to have its proprietary, fully-humanized version of Cytolin® ready for bulk manufacturing this Autumn in time for the follow-up clinical trial. Based on the advice of its patent attorneys, the Company believes its fully-humanized product will be eligible for a new patent to complement and extend its existing portfolio of intellectual property, which includes patents on the use of any such antibodies to treat HIV/AIDS.

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.

Enrollment Open For Clinical Trial of Cytolin®, A Novel Immune Therapy From CytoDyn For Treating Early HIV Infection

Santa Fe, NM ― January 19, 2009 ― (BUSINESS WIRE) — Following approval of the Institutional Review Board, CytoDyn, Inc. (Pink Sheets: CYDY) has discharged its duty to register a clinical trial of Cytolin®, the Company’s lead product, with the government’s website at www.clinicaltrials.gov, ID NCT01048372. The public has online access to this federal database, which describes the key elements of clinical trials and their status. To peruse the continually updated public record for the study of Cytolin® on the government’s website, enter “HIV AND Boston AND Cytolin” as search terms (case sensitive).

Human subjects are now being recruited for the study from the clinic of the Principal Investigator. The study protocol calls for 10 adults with early HIV infection and 10 healthy control subjects. According to the study protocol, it could take up to one year to fill these 20 slots. Although the Company expects enrollment to be completed in a shorter period of time, there can be no guarantee that enrollment will be completed in less time than is permitted by the study protocol.

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 funding and cGMP product to the General Hospital Corporation, doing business as 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 or 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’s New Approach to Drug Development: Why We Think It’s Better

By Allen D. Allen
CEO CytoDyn, Inc.

Santa Fe, NM ― January 6, 2010 ― (BUSINESS WIRE) — As reported by AIDS Treatment News on December 31, 2009, CytoDyn, Inc. (Pink Sheets: CYDY) has entered into an Agreement with The General Hospital Corporation d/b/a Massachusetts General Hospital for a clinical trial of Cytolin®, our Company’s novel immune therapy for treating HIV/AIDS. The Agreement between CytoDyn and Massachusetts General Hospital takes a different approach to new drug development that merges elements of the private and public sectors. CytoDyn believes this approach is superior to the standard modalities because it can provide:

• Enhanced ROI for pharmaceutical companies.
   
• Reduced burden on tax payers.
   
• Accelerated progress in clinical medicine.

New Drug Development in The Public Sector

The federal government obtains tax dollars from individuals and corporations on an involuntary basis and redistributes those dollars to public teaching hospitals for the purpose of funding basic medical research. The government reduces risk (the risk of criticism) by funding research that is popular in the academic community and is otherwise politically correct. However, as is generally true in academia, researchers are under no obligation to produce results that have utility or that provide taxpayers with any tangible benefits. On the other hand, faculty members at most public teaching hospitals are expected to publish original research papers in the peer-review journals. Since these published papers constitute a contribution to medical knowledge, this knowledge provides society with an intangible benefit in return for the tax dollars expended. Moreover, the basic research conducted by such institutions sometimes contributes to a tangible benefit for society. As a case in point, a significant portion of the basic science that underlies Cytolin®, i.e., the “prior art,” was funded by the National Institute of Allergies and Infectious Diseases.

New Drug Development in The Private Sector

Individual and institutional investors voluntarily place their money at risk to provide operating capital for use by the drug companies. These for-profit companies spend hundreds of billions of dollars conducting clinical trials. Most of the drugs studied wind up failing because they were selected on the basis of intuition, fad theories, anecdotal observations or microbiological phenomena. Nonetheless, the new drugs that are successful can generate such large earnings that the drug companies have historically offered investors a substantial return on investment. In contemporary times, however, the pressure to constrain the costs of prescription medications, along with the economic downturn, have motivated the drug companies to reduce risk by favoring “me too” drugs, i.e., new drugs that differ from successful drugs only to the extent necessary to satisfy the novelty requirements of patent law. This has had the inevitable effect of limiting innovation, making it less likely that a drug company will develop a new drug that leads to a significant advance in clinical medicine.

New Drug Development at CytoDyn

The study CytoDyn is funding at Massachusetts General Hospital is science-intensive and is intended as a prelude to a follow-on clinical trial at the same Institution. Over and above conducting the study, Massachusetts General Hospital, not CytoDyn, designed the study and serves as its sponsor, all as part of its 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 drugs and information,” to quote the recitals of the Agreement between Massachusetts General Hospital and CytoDyn.

In other words, CytoDyn is funding research of a type that is usually funded by the government, except that the funds represent money voluntarily placed at risk by investors rather than tax dollars. While CytoDyn will retain its intellectual property rights and will have access to the study data, it will not own the data, which will be owned by Massachusetts General Hospital. This research, therefore, provides Massachusetts General Hospital with an opportunity to pursue its mission of conducting relevant and potentially seminal research using funds from a non-governmental source representing a deep-pocket segment of the economy. This would not be possible in the case of a drug that does not reflect a potential scientific breakthrough, such as a “me too” drug.

One advantage for CytoDyn is in avoiding the high costs associated with the FDA’s regulation of clinical trials, especially when those trials are sponsored by a drug company. These regulations are intended to protect the public from what, in this author’s opinion, is more a case of innumeracy than greed on the part of the drug companies. While cynics may tend to blame greed when unsafe drugs manage to escape regulatory safeguards, it ill serves the bottom line of a drug company to market a new drug that is initially profitable but has to be withdrawn due to safety issues and then generates billions of dollars in extraordinary expenses needed to settle or defend litigation.

In summary, the approach to new drug development funded by CytoDyn at Massachusetts General Hospital:

1. Provides pharmaceutical companies with an improved and cost-effective way of moving new drugs through the FDA, a benefit for the shareholders of those companies.
    
2. To gain this advantage, pharmaceutical companies must develop breakthrough drugs that significantly advance clinical medicine in order to qualify as research appropriate for public teaching hospitals. The resulting progress in clinical medicine would accrue to the benefit of the public.
    
3. In the process, billions of dollars are made available from the private sector for research to be conducted at public teaching hospitals, reducing the burden on taxpayers.

CytoDyn Completes Safety Testing of Cytolin^®: Benchmark for Improved Treatment of HIV/AIDS.

Santa Fe, NM ― July 22, 2009 ― (BUSINESS WIRE) ― CytoDyn, Inc. (Pink Sheets: CYDY) has completed safety testing of its current inventory of Cytolin^®, the Company’s immune-system modulator for managing HIV disease and the public health crisis afflicting communities where the infection is spreading due to unprotected sex and the other risk factors for AIDS. Tests for specific adventitious agents and other quality parameters following purification were performed by the manufacturing facility, Vista Biologicals Corporation of Carlsbad, California. The other safety tests, including in vivo general safety using two animal species, were performed by WuXi AppTec, a fully integrated pharmaceutical, biotechnology and medical-device company with facilities in St. Paul, Minnesota. WuXi AppTec provides R&D services to the biotechnology industry. Since the product is intended for use in a clinical trial, the tests conducted were those required for each new batch of a biologic agent manufactured for use in human research. The Company believes that the test results satisfy the current safety standards for the manufacturing of drugs belonging to the class of biologics. The results are summarized in the table below.

About Safety Testing

Product safety testing evaluates the quality of the manufacturing process in order to avoid risks to the health of human subjects that can arise from the way a particular lot of a drug was manufactured. The intrinsic safety of a drug intended for use in humans can only be ascertained from the response of human subjects to that drug. In previous human studies, multiple infusions of Cytolin^® were well tolerated, as reported in a newly released documentary and at a previous Conference on Retroviruses and Opportunistic Infections (CROI) by the Principal Investigator, Donald W. Northfelt, MD, then at the Eisenhower Medical Center in Palm Desert, California.

About Cytolin^®

Cytolin^® is a first-in-class immune modulator intended for use in combination with antiretroviral drugs in order to increase the effectiveness of the drugs used to manage HIV and AIDS while reducing the costs of treating those diseases. In part, Cytolin^® is designed to achieve these goals by preventing the emergence of drug-resistant strains of HIV. Unlike the other drugs used to treat HIV and AIDS, Cytolin^® does not promote resistance due to natural selection because it is not an antiviral drug. Rather, Cytolin^® is based on research revealing the reasons why chimpanzees can carry chronic HIV infection without ever developing AIDS and is intended to give humans a similar advantage.

Status of Cytolin^®

The Company is currently engaged in confidential negotiations with a major academic institution in the Eastern United States for the purpose of having the next clinical trial of Cytolin^® conducted by a thought leader in the field under an Investigator’s IND. The purpose of the study would be to confirm and elaborate the immunologic mechanisms believed responsible for the clinical benefits observed in earlier human studies of Cytolin^®. However, the Company cannot guarantee that such a clinical trial will be successfully mounted or that the study will be successfully completed or that the research will produce the expected results. If conducted under an Investigator’s IND, the academic researchers would be free to publish the study results as they see fit without interference from the Company.

To date, Cytolin^® has only been used in approximately 200 patients and it has not been used in human subjects for periods in excess of 18 months. Consequently, its long-term safety and efficacy have not been established. Clinical research entails many uncertainties and the results from large, multicenter clinical trials may differ substantially from the results obtained during preliminary clinical trials. Furthermore, if public health officials succeed in responding to the health crisis emerging in communities where HIV infection is on the rise by encouraging safe sex and by reducing the other risk factors for HIV and AIDS, then the potential market for Cytolin^® would be reduced.

Key words: HIV, AIDS, research drugs, diseases, health crisis, safe sex

This news release was approved by the Committee on Nominations and Corporate Governance of the Board of Directors of CytoDyn, Inc.

CytoDyn Names New CFO, Welcomes New Director

Santa Fe, NM ― July 8, 2009 ― (BUSINESS WIRE) ― Corinne Allen has been elected Chief Financial Officer of CytoDyn, Inc. (Pink Sheets: CYDY) after discharging many of the duties of that office following the semi-retirement of Wellington Ewen, the Company’s original CFO. CytoDyn wishes to express its unequivocal and sincere appreciation to Mr. Ewen for his years of dedicated service. In order to enhance the independence of the Company’s Board of Directors, Ms. Allen has resigned from the Board.

She was replaced on the Board of Directors by Jordan Naydenov, the quintessential self-made man. Prior to 1982, Mr. Naydenov was an accomplished gymnast in Bulgaria. After immigrating to the United States, he purchased a gymnasium and subsequently parlayed his holdings into a successful business empire. He purchased and remains on the Board of Milara, Inc., a leading provider of stencil and screen printing systems for the surface mount and semiconductor industries. The Company is of the opinion that his business acumen and contacts will make Mr. Naydenov a valuable addition to its Board of Directors.

 

CytoDyn Explains How Documentary Movies Are Made

Los Angeles, CA ― June 14, 2009 ― (BUSINESS WIRE) ― As previously reported on May 11, 2009, Evolution Media of Burbank, CA is producing a video documentary about Cytolin®, the first immune modulator for treating HIV/AIDS that has consistently shown serological and clinical benefits in early human experience. It is the lead drug of CytoDyn, Inc. (Pink Sheets:CYDY).

Recently, CytoDyn has been receiving calls from its shareholders asking why the documentary is not yet available for viewing over the Internet. Many people who do not work in the entertainment industry probably believe that the task of producing a video documentary is only slightly more cumbersome than the making of a home movie using a modern digital camera and the widely available editing software/freeware. As a consequence, the Company has a desire and, arguably, a duty to explain how documentary movies are made for the benefit of its shareholders.

PRE-PRODUCTION

CASTING: The first step was to determine a cast of experts who could talk about the subjects that the documentary covers: epidemiology, science, medicine, drug development, and bio-economics. In addition to being knowledgeable, cast members had to be articulate and, since this is television, needed to present a decent and professional image to the camera. They also needed to be willing. Unlike entertainment projects that pay actors anywhere from union scale to millions of dollars for their performances, individuals appearing in a documentary are usually not compensated. Not surprisingly, therefore, most but not all of the cast members are CytoDyn employees.

SCRIPT: Once the cast was determined, a list of questions was prepared for each member of the cast. Although the questions themselves do not appear in the documentary, the director asked each member of the cast a series of questions in order to have him or her expound on the desired subjects. The same question was asked repeatedly in order to get different “takes” from the individual being interviewed.

LOCATIONS: The physical locations where the documentary was shot were determined on the basis of logistics, cost, and visual appeal. The documentary was shot in two locations, one in Southern California and one in Arizona.

PRINCIPAL PRODUCTION

Once the cast, script and locations had been determined, the next step was to tape the raw footage from which the documentary was assembled. The raw footage was shot over a period of two days, one day in each location. A minimum crew was used that included a director, a camera operator, a gaffer to handle lighting, a sound engineer to record the dialog, a boom operator to hold the microphone boom, and a make-up artist. About six hours of raw footage was shot for what ended up being the short documentary intended.

POST-PRODUCTION

PAPER CUT: A written transcript was prepared indicating exactly what each cast member said during the six hours of raw footage. This transcript was used to select the footage that was used for the documentary so that each desired subject was covered in as clear and compelling a way as possible.

GRAPHIC ELEMENTS: Graphic cards were prepared that indicate the beginning of each section of the documentary, which is divided into five sections:

1. The global impact of the HIV pandemic.
    
2. The limitations of the generally successful antiretroviral drugs used to treat HIV/AIDS, and the increasing need for immune-based drugs.
    
3. The multicenter scientific research that led to Cytolin®, an immune-based drug, and the clinical and serologic benefits that have been seen in patients treated with Cytolin®.
    
4. Stage of drug development.
    
5. An invitation to viewers to learn more over the Internet.

MUSIC: CytoDyn’s CEO, Allen D. Allen, in addition to being a scientist with an extensive bibliography of papers published in the peer-review science and medical journals, is a Life Member of the American Federation of Musicians, a composer/lyricist member of ASCAP, and a recipient of the 1958 BMI Country Music Award. He spent many previous years as a successful film composer. Consequently, CytoDyn provided the music for the documentary.

PRELIMINARY ROUGH CUT: The selected videotaped segments were assembled, the graphic cards added, and the music dubbed into the sound track to produce a Preliminary Rough Cut. The Preliminary Rough Cut was presented to the staff at Evolution, and to CytoDyn, which is concerned with the accuracy of material related to science and medicine, as well as public relations, and regulatory compliance. It was determined that there needed to be three minor revisions to the Preliminary Rough Cut in order to have a Final Rough Cut, which is being created as of this writing.

B-ROLL FOOTAGE: B-Roll Footage refers to live action that illustrates what an individual being interviewed is talking about. This will be added to the Final Rough Cut to produce a Final Cut or “Negative” so that the documentary will consist of more than just “talking heads.” Because the documentary covers several subjects, some of which are technical and others of which concern the human experience, the B-Roll Footage shot during Principal Production will not be adequate and must be supplemented by stock footage. This is typical of documentaries that are concerned with more than just a few products, all of which could be filmed or taped in one location, such as a factory.

STOCK FOOTAGE: Because HIV/AIDS is a real and a serious disease, CytoDyn has presented Evolution with the daunting challenge of securing stock footage that is precise and accurate. In entertainment projects, stock footage is often imprecise and inaccurate. In the film “Deterrence,” for example, a movie that was produced after the Gulf War and ironically shown on television one day before 9/11/2001, a 100 megaton hydrogen bomb explodes over Baghdad in an imaginary future. The stock footage used for the nuclear explosion shows the test of an atomic bomb that was conducted at sea by the U.S. in the South Pacific prior to the Test Ban Treaty. You can just see the ring of ships anchored around the denotation site. For the attentive viewer, this pretty much destroys suspension of disbelief and the idea that the bomb detonated over Iraq. Having this kind of inaccuracy in the documentary would, in CytoDyn’s opinion, be socially irresponsible and could invite complaints from regulators.

LOOKING FORWARD

CytoDyn hopes that the documentary will be completed within a few weeks but there is no guarantee that this will be the case. More generally, this press release contains forward-looking statements that are not historical facts. CytoDyn’s management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements 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. 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 staff assembles for taping of a documentary about Cytolin®, the immune therapy for treating HIV/AIDS under development by CytoDyn, Inc. (CYDY). Clockwise: Corinne Allen, Vice President; Michelle Ferrari, Public Affairs; Dr. Nader Pourhassan, COO; Allen D. Allen, CEO.

Independent TV Producer Taping Documentary About CytoDyn

Carlsbad, CA ― February 13, 2009 ― CytoDyn, Inc. (Pink Sheets: CYDY) made a site visit to Vista Biologicals Laboratory to tour the laboratory and inspect the Company's product and documentation. The Manufacturer's estimate of the timeline for completing the current batch of Cytolin® appears in the continuously updated table below. This bulk cGMP product was made in a 100 liter bioreactor using serum free media.

 

Manufacturing Tasks	Estimated Completion Date
Purify cGMP Product for Clinical Trial	Completed
General Safety and QA Testing (sent out to WuXi AppTec)	Completed
Vialing	N/A

CytoDyn’s management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements 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. 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.

Video Tour (4:34)

CytoDyn Awarded Global Patents For Modernizing The Treatment of Infectious Diseases

Santa Fe, NM ―  December 3, 2008 ― Business Wire ― CytoDyn, Inc. (Pink Sheets: CYDY) has rounded out its European patent portfolio with new patents in Ireland, France, Switzerland, Austria, Luxembourg, Netherlands, and Germany. The Company is also receiving new patents in Hong Kong and Canada.

CytoDyn’s patent portfolio protects a platform method of treating HIV/AIDS as a first step toward modernizing global healthcare in an environment with finite resources.

Treating Infections

When the environment turns toxic for some particular form of life, that life-form either goes extinct or evolves into a new species that is adapted to the new environment, a process referred to as natural selection. Disease-causing germs tend to be hardy and adaptive and, as such, usually do not go extinct. Rather, the widespread use of antimicrobial drugs to destroy germs will cause those germs to evolve into drug-resistant species. The traditional approach to this problem has been an unending chain of new drugs to treat the germs that have become resistant to the old drugs until such time as the germs become resistant to the new drugs, and so on. This approach has maintained long-term profitability for the drug companies while escalating the costs of healthcare.

Fortunately, or unfortunately, this traditional way of dealing with natural selection cannot go on indefinitely. There is only a finite number of chemical structures that can be used to kill germs. Despite the eventual failure of this approach, the medical-pharmaceutical-regulatory complex has resisted innovation for the same reason that the American automobile manufacturers were slow to admit to the need for fuel-efficient vehicles, despite a dwindling supply of oil. For one thing, retooling requires a substantial capital investment. For another, innovation marginalizes the engineers and managers whose expertise centers on the designing, manufacturing, and marketing of traditional products.

The Human Immunodeficiency Virus (HIV)

HIV has an evolutionary advantage in that it mutates rapidly and spontaneously into hundreds of new species. (This is one reason attempts to develop an effective AIDS vaccine have failed.) As a consequence, HIV can become resistant to new drugs much faster than most germs can. Fortunately, HIV belongs to a large class of germs that do not cause disease directly but only because of the response of the human immune system. Other familiar diseases that belong in this category include serum hepatitis and Lyme arthritis. In scholarly journals that strive for scientific rigor you will never read that HIV “causes” AIDS or that Borrelia burgdorferi “causes” Lyme arthritis. Rather, these are referred to as the “infectious agents.”

Diseases that have infectious agents can be treated in two different ways. One is the traditional method of killing the germ, and the other is to modulate the immune response so it does not cause disease. Using both methods would surely be the most effective. In practice, however, one or the other is used depending upon the pipelines of the pharmaceutical companies with the resulting indoctrination of healthcare providers, researchers, and regulators. While HIV disease has traditionally been treated only with antiviral drugs that kill the virus, the gold standard for treating Hepatitis B is the biologic agent interferon-alpha, an immune modulator that protects liver cells from the immune response to the virus.

About Cytolin®

The Company's lead product Cytolin® is a monoclonal antibody that blocks a weakness in the human immune system so it can control HIV infection as effectively as other species of primates can control it. Because the immune system suppresses all species of HIV, including drug-resistant species, Cytolin® is intended for use in combination with antiviral drugs. By suppressing drug-resistant species of HIV as they emerge, Cytolin® should extend the time the antiviral drugs are effective, thereby compensating for natural selection.

Disclaimer

This press release contains forward-looking statements that are not historical facts. CytoDyn’s management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements 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. 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, or other factors that may be identified from time to time in the Company's announcements.

Santa Fe, NM ― October 21, 2008 ― CytoDyn, Inc. (Pink Sheets:CYDY) has filed a new IND for a study to reconfirm dose ranging and to "prove the principle" with a randomized, double-blind placebo controlled study of Cytolin®, the Company's first-in-class drug for treating HIV/AIDS. This comes 13 years after the first IND was issued for the drug. Initially, Cytolin® was used experimentally by community physicians to rescue 200 - 300 AIDS patients over a period of two years before the antiretroviral cocktails had become available, as reported by CBS-TV News. Subsequently, the drug's inventor and his associates learned the pitfalls of out-licensing technology in an environment where innumeracy created a fertile field for unfettered corporate malfeasance. The new study, the first to be sponsored by the drug's developers, will reconfirm dose ranging and will use the gold standard of the randomized, double-blind, placebo controlled trail to eliminate the need for the industry and public health officials to become familiar with a decade of progress in immunology.

The current need for Cytolin® arises because of natural selection, which has caused HIV to mutate to multi-drug resistant strains. The Financial Times, for example, recently reported that 30 out of 100 HIV-infected people in the Democratic Republic of the Congo carried strains of HIV that were resistant to the standard AIDS drugs they were being given. Cytolin® does not promote mutation of HIV to drug resistant strains, and treats all species of the virus, because it helps the human immune system re-establish control over the infection instead of attacking the virus directly. When first infected with HIV, a person's immune system controls the virus for several years or even a decade or more before losing control of the infection. In discovering why other species of primates can carry HIV infection without becoming ill, three researchers working independently discovered why the human immune system uniquely loses control of HIV infection. This research, published in the early 1990s, was conducted by Joyce Zarling, Leonard Adelman, and Allen D. Allen, CytoDyn's CEO. Cytolin® compensates for this unique trait of human immunity to help the immune system reassert control over the infection.

The Company has no estimate of how long it will take the FDA to review the Company's application. Other factors that can delay successful completion of a study's benchmarks are available on the Company's web site. This press release contains forward-looking statements that are not historical facts. CytoDyn’s management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements 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. 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 Relocates Offices to Accommodate Expanded Activities

Santa Fe, NM ― October 7, 2008 ― Business Wire ― CytoDyn, Inc. (Pink Sheets:CYDY) has relocated its business offices to 1511 Third Street, Santa Fe, NM 87505. The Company’s phone will be its original number (505) 988-5520 effective October 13, 2008. The FAX number remains the same: 800-417-7252. The expanded office space will accommodate the staff needed to bring CytoDyn’s periodic filings up to date. Pender, Newkirk & Company, LLP of Tampa, FL continues to serve as the Company’s auditors.

In addition to becoming current in its filings, CytoDyn anticipates the next clinical trial of Cytolin®, ―the Company’s first-in-class drug for treating HIV/AIDS. The study will be conducted by prominent AIDS researcher Dr. Jay Lalezari in San Francisco, California with GMP product manufactured in San Diego, California. The study will be managed by Target Health, Inc. of New York, NY, which the Company has retained to serve as its Contract Research Organization (CRO).

CytoDyn is also pleased to announce that Parviz Lalezari, M.D., a prominent immunohematologist at the Montefiore Medical Center in New York has joined the Company’s Scientific Advisory Board.

This press release contains forward-looking statements that are not historical facts. CytoDyn’s management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements 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. 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 Begins GMP Manufacturing of Its First-In-Class AIDS Drug

Los Angeles, CA ─ July 2, 2008 ─ Business Wire ─ CytoDyn, Inc. (Pink Sheets: CYDY) has begun GMP manufacturing and humanization of Cytolin®, a monoclonal antibody that uses the human immune system to control HIV infection. The murine version of this product, for which there is already considerable human experience, will be used for a fast, randomized, double-blind, placebo-controlled clinical trial to supplement the data from a previous Phase Ib/IIa study.Ordinarily, pristine proof-of-principle requires a Phase III study. However, in the case of HIV/AIDS, a significant reduction in viral burden is universally accepted as a surrogate marker that reliably predicts reduced morbidity and increased life expectancy.

The human subjects who will be enrolled in the Company’s upcoming clinical trial will be adults with HIV infection who have significant viral burdens because they are not yet candidates for, or have declined, antiretroviral drugs. This eliminates the confounding factor of having patients who are taking a variety of other drugs. Jacob Lalezari, MD, a prominent clinical researcher, will be the principal investigator for the study to be conducted in San Francisco, California. The Company will be making every effort to have the study completed before the end of 2008, although such timelines can never be guaranteed.

About Cytolin®

HIV infects other species, such as chimpanzees. But only humans get sick from HIV infection. In the early 1990s, several teams of university-based scientists reported in the peer-review literature that this unique response of humans to HIV infection is because of a flaw in the human immune system. Cytolin® is designed to correct that flaw. This is different from "reconstituting" the immune system, which can make patients sick ("immune reconstitution syndrome").  With the human immune system working better, we would expect it to do a better job of controlling HIV infection, as it does for several years following acquisition of the infection. Preliminary empirical evidence illustrating this benefit appeared in earlier clinical trials, and in the original pilot study summarized by the graphic on our home page at www.cytodyn.com.

The Need for Cytolin® (Indications)

The advent of the antiretroviral drugs and the concomitant use of three for Highly Affective Antiretroviral Therapy (HAART) has transformed HIV/AIDS from a death sentence into a serious but manageable chronic illness. The most recent and most effective of these drugs are the non-nucleoside reverse transcript inhibitors (NNRTI). Several have been recently approved, including Sustiva® (efavirenz) from Bristol-Meyers Squibb (NYSE: BMY), and Rescriptor® (delavirdine) from Pfizer (NYSE: PFE). Bristol-Meyers Squibb and Gilead (NasdaqGS: GILD) are now marketing a convenient three-in-one drug Atripla®, which consists of efavirenz, tenofovir, and emtricitabine. The two drugs in addition to efavirenz belong to the older class of nucleoside reverse transcript inhibitors (NRTI). Reverse transcript inhibitors prevent retroviruses such as HIV from replicating.

One problem is that HIV can rapidly develop resistance to drugs that interrupt its life cycle due to natural selection. This has created a small but growing population of patients who have run out of treatment options and are in need of salvage therapy. Because a properly functioning immune system should control any strain of HIV, Cytolin® could help salvage those patients who are infected with drug-resistant strains of HIV. It might even prevent drug resistance from developing when used in combination with antiretroviral drugs by suppressing drug resistance strains as they emerge.

As another promising use for Cytolin®, it might be given once a month or so (it is given as an intravenous infusion) in order to delay the need for antiretroviral drugs. Patients are usually advised not to start antiretroviral drugs until the disease has progressed for the following reasons: (Source: http://aidsinfo.nih.gov/contentfiles/HIVandItsTreatment_cbrochure_en.pdf)

“Once you begin treatment, you may need to continue taking anti-HIV medications for the rest of your life. Although newer anti-HIV medications are easier to take, starting treatment usually means a significant adjustment in your lifestyle. Some anti-HIV medications need to be taken several times a day at specific times and may require a change in the foods you eat, when you eat meals, and when you take other medications.

“In addition to their desired effects, anti-HIV medications may have negative side effects, some of which are serious. If the virus is not suppressed completely, drug resistance can develop. Side effects and drug resistance may limit your future treatment options.”

Disclaimer

This press release contains forward-looking statements that are not historical facts. The Company's management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements 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 scientific studies to reflect the results from more comprehensive studies. 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 factors that could cause actual results to differ materially from those estimated by the Company. 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.