Los Angeles, CA - May 11, 2009 - Business Wire - CytoDyn, Inc. (Pink Sheets: CYDY) is featured in a documentary about its lead product Cytolin®, the first immune based drug for HIV/AIDS that has been successfully used in about 200 patients to prevent the human immune system from self-destructing in response to HIV infection. This story was previously reported by Dr. Cynthia Allison in an investigative series from CBS TV News. The new documentary tracks the Company’s steady progress despite the fact that it usually takes 20 years and some very tenacious researchers to bring a new drug to market, even when experts know the drug will save lives. Examples of the latter include the history of two oncology drugs, in the same class as Cytolin®, that are now mainstream cancer treatments: Avastin® from Genentech (EBS: DNA) and Erbitux® from Imclone (NasdaqGS: IMCL).

Allen D. Allen, CytoDyn’s CEO, tells viewers that even if researchers had already discovered cures for amyotrophic lateral sclerosis (Lou Gehrig’s Disease), cystic fibrosis, scleroderma, and other serious diseases, it would be decades before those drugs were available, and we might never know about them, because of the many obstacles that impede and prevent new drug development.

The documentary, which is not yet titled, is being produced by Evolution Media of Burbank, California, a full-service production company that has been known for innovative programming since 1987. Evolution produces network and cable TV programming, promos, documentaries, children’s and educational programming, main and end titles, and corporate media. Their credits include “The Real Housewives of Orange County.” The release date for the CytoDyn documentary is pending.

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.

Source:

CytoDyn

Contact:
Corinne Allen 1-505-988-5520

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.

SANTA FE, N.M.–(BUSINESS WIRE)– CytoDyn, Inc. (Pink Sheets:CYDY) has sent the FDA what the Company believes is a complete response to the agency’s preliminary comments on Cytolin®, a monoclonal antibody designed to restore immune function in those afflicted with HIV/AIDS.

As one example of how this process works, the FDA asked CytoDyn to conduct a laboratory experiment to quantify the effect of Cytolin® on HIV. In its response, the Company explained that an immune modulator cannot have a direct effect on a virus making what the FDA requested a scientific impossibility. Rather, the reduction in HIV levels consistently observed in patients treated with Cytolin® is due to improved functioning of the immune system, as confirmed by a restored ability of patients treated with Cytolin® to recognize five germs to which most adults have been previously exposed. This effect is studied by injecting a small quantity of dead germs just under the skin and is referred to as a resolution (cure) of cutaneous (skin related) anergy (lack of immunologic activity). It was first observed in the earliest human study of Cytolin®, a small pilot study conducted by AIDS reSEARCH ALLIANCE in 1995 and subsequently reported in the peer-review literature.

As another example, the FDA expressed a concern that Cytolin® -which reduces HIV levels indirectly by strengthening the immune system, might suppress the immune system and exacerbate infections. Precisely because this concern is nonsensical, it underscores the impact of the criticism that was directed at the FDA after the approval of Raptiva®, an antibody designed to be the opposite of Cytolin® and to suppress the immune system as a treatment for moderate to severe plaque psoriasis, a disease caused by a hyperactive immune system and characterized by rash, fever, chills, and severe itching. Raptiva® is the registered trademark of Genentech (NYSE:DNA). In other words, it is as if the FDA had been criticized for allowing a company to pour water on a fire that was out of control after some patients alleged this had left them susceptible to infections. The FDA is now concerned that pouring gasoline on a fire weakened by HIV will do the same thing as water because the agency lacks the expertise to distinguish between two very different fluids.

Section 117 (C)(3) of the Food and Drug Administration Modernization Act of 1997 requires the FDA to act within 30 days of receipt of a complete response to its preliminary comments. However, it is common knowledge that the FDA is seriously underfunded and understaffed. Consequently, the FDA may not be capable of complying with this provision of the law even if it agrees that CytoDyn’s response was complete. The inadequate staffing of the FDA, and the resulting impairment of that agency, was cited by Public Citizen in support of the recent ruling by the U.S. Supreme Court rejecting the policy of the Bush Administration, which precluded patients from suing for damages allegedly caused by FDA-approved drugs. In other words, the impairment of the FDA due to inadequate funding has been cited as one reason why FDA approval should not be deemed to imply drug safety. The counter argument asks why the drug companies should be compelled to spend billions of dollars for FDA approval, thereby increasing the already staggering costs of health care, if that approval does not provide assurances of drug safety.

Contacts

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

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 table below. This bulk GMP product was made in a 100 liter bioreactor using serum free media.

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.

Santa Fe, NM - December 19, 2008 - Business Wire - After meeting with representatives of the Xishan Economic Development Zone in Albuquerque, New Mexico, CytoDyn, Inc. (Pink Sheets: CYDY) has committed to a feasibility study in the People’s Republic of China. Dr. Feng Zhou, a Company consultant, will travel to China in the immediate future to confer with workers at the sFDA and selected biotechnology facilities on CytoDyn’s behalf.

After training at the Xiamen University in Xiamen, China from 1981-1985, Dr. Zhou worked on the development of flow cytometry at the Los Alamos National Laboratory (LANL) near Santa Fe, New Mexico from 1999-2002. Although best known for the Manhattan Project, LANL played a key role in the development of flow cytometry, a technology that made it possible to study and diagnose immunologically-mediated diseases such as HIV/AIDS. Since 2003, Dr. Zhou has been an Adjunct Assistant Professor at the School of Medicine, University of New Mexico in Albuquerque, New Mexico.

Support for science-based innovation, drastically reduced costs of drug development, and an ability to maintain international cGMP standards for quality assurance will be key factors in shaping CytoDyn’s Asian strategy.

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.

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.

CytoDyn, Inc.

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.

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.

Los Angeles ─ June 5, 2008 ─ Business Wire ─ Following a management meeting in San Francisco on June 7, representatives of CytoDyn, Inc. (Pink Sheets: CYDY) will be meeting with Principle Investigator Dr. Jay Lalezari at Quest Clinical Research to finalize the Company’s strategy for a Phase II trial of Cytolin®. An immune therapy that uses the human immune system to control HIV infection, Cytolin® was used for two years before the antiretroviral cocktails became available to delay the progression of AIDS in about 200 patients, as reported by CBS-TV News.

Because the standard for treating HIV/AIDS is rapidly evolving, the Company must decide on the best indication to pursue prior to submitting a protocol to the FDA. On the one hand, patients failing Highly Active Antiretorviral Therapy (HAART) have an urgent need for treatment options. On the other hand, experts recognize a benefit to delaying initiation of antiretroviral therapy until medically necessary because starting treatment may mean a change in the patient’s lifestyle, some antiretreoviral drugs have serious side effects, and resistance may develop, which limits future treatment options. Based on previous clinical experience, Cytolin® might also be used to control HIV infection delaying the need for antiretroviral therapy.

About Quest Clinical Research

Quest Clinical Research provides clinical research dedicated to the development of new therapies for treating life-threatening viral illnesses, such as HIV/AIDS, Hepatitis B and C, CMV infection and influenza. It has provided access to investigational drugs to over 5,000 individuals throughout Northern California since 1989 at no cost to patients.

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 is because of a flaw in the human immune system. Cytolin®, a monoclonal antibody, 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.

Disclaimer

This press release contains forward-looking statements that are not historical facts but only reflect the Company’s estimates and projections. There are many factors, known and unknown, that could cause actual results to differ significantly. These factors include, but are not limited to, unanticipated problems and accidents during the manufacturing process, unexpected regulatory difficulties, unexpected difficulties with patient enrollment, unexpected study results, economic downturns, the effects of adverse publicity, litigation, competition, victimization by white-collar offenders, and other factors that may be identified from time to time in the Company’s announcements.