CytoDyn on Target With Target for Electronic FDA Application

Glorieta, NM and New York, NY─ July 28, 2008 ─ Business Wire ─ CytoDyn, Inc. (Pink Sheets:CYDY) has selected Target Health, Inc. for the preparation and electronic filing of CytoDyn’s upcoming FDA application using Target Health’s proprietary e*CRF® system. The advantage of Target Health is based on its core expertise in regulatory affairs and clinical research, and its paperless approach to FDA filings, including submission of electronic INDs (eIND) and electronic common technical documents (eCTD). Paperless clinical research and the electronic filing of regulatory documents reflect a growing trend in the pharmaceutical industry. Dow Pharmaceutical Sciences (NYSE:DOW), King Pharmaceuticals (NYSE:KG) and Pain Therapeutics (Nasdaq:PTIE) are among the leading pharmaceutical companies that have helped pioneer this modernization of the industry.

About CytoDyn

CytoDyn, which expects its first electronic application to be submitted to the FDA in about eight weeks, is developing Cytolin®, a first-in-class drug that uses the human immune system to help control HIV infection. Because a well-functioning immune system can usually control a virus regardless of its subspecies, this could potentially provide a “salvage” therapy for those failing antiretroviral therapy. For the same reason, it might help prevent drug-resistance strains of HIV from ever emerging when used in combination with traditional antiretroviral drugs.

At the height of the AIDS epidemic, community physicians treated about 200 patients experimentally with a generic form of Cytolin® to delay the need for antiretroviral therapy, which had not yet become fully available, as previously reported by CBS-TV News. This might also turn out to be a way of using a drug like Cytolin® since, despite the great strides that have been made in treating HIV/AIDS, the U.S. Department of Health and Human Services recommends delaying the use of antiretroviral drugs until the disease has progressed to the point where such drugs are indicated.

CytoDyn has not yet decided which of these potential uses for Cytolin® it will pursue as an initial indication, pending completion of its upcoming clinical trial. The upcoming trial will re-investigate dosing and is designed to be pristine in order to qualify as a proof-of-principle study. Although not the first clinical trial of Cytolin®, it will be the first clinical trial sponsored by CytoDyn, whose CEO invented this treatment. The Principal Investigator is Dr. Jay Lalezari, a prominent clinical researcher in San Francisco California specializing in HIV/AIDS. Dr. Lalezari was instrumental in defining the parameters of a proof-of-principle study under the current treatment guidelines.

About Target Health

Target Health, Inc. is a New York City-based full service e*CRO with full-time staff dedicated to all aspects of Regulatory Affairs, Clinical Research, Biostatistics, Data Management, Paperless Clinical Trials (Target e*CRF®, Target Document®, Target Encoder®, Target e*CTMS™), Software Development, Strategic Planning and Drug/Device/Biologic Development. Target Health, Inc. currently represents 28 companies at the FDA and two companies at Health Canada. Target’s clients include Fortune 100 companies as well as many smaller companies. A complimentary newsletter, “On Target,” is available from Target Health, Inc. for those interested in contemporary drug-development issues.

“We were impressed with the broad experience, rapid response, and flexibility of Target Health, Inc., and gained a sense of security from the positive outcome of an on-site audit of that company conducted by the FDA,” said Dr. Nadar Pourhassan, CytoDyn’s COO.

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, 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 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.

CytoDyn to Meet With Quest Clinical Research to Finalize Phase II Strategy for Novel AIDS Drug

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.