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  CytoDyn, Inc.(CYDY.OB)
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CytoDyn Inc. (CYDY.OB)
Stock symbol: CYDY.OB……………………..……………….……..…..Float: 3.7mm shares

Stock price 2/16/06: $2.25……..…………..…………….Common shares (1/16/06: 8.6mm)

52-week price range: $.50 - $3.00……..……..……Equity market capitalization: $19.4mm

Recent News…..Stock Price…..Chart…..SEC Filings

Listen to the Interview with Allen D. Allen, CEO (click)

BUSINESS

  • Created the AIDS drug Cytolin
  • The first targeted immune therapy for treating HIV/AIDS
  • That significantly reduced viral burden in preliminary studies.
  • RECENT DEVELOPMENTS

  • Selects Quest clinical research for next trial of HIV/AIDS immune therapy
  • Signs joint venture letter of intent for China
  • Retains DC Law Firm of Hyman, Phelps & McNamara. Established in 1980 and has since developed one of the most extensive food and drug practices in the United States.
  • Picks San Francisco for next trial
  • -----------------------------------------------------------------------

    Address: 227 E. Palace Avenue, Suite M, Santa Fe, New Mexico 87501

    Telephone: (505) 988-5520

    CEO: Allen D. Allen, CEO

    Web Site: http://www.cytodyn.com/

    State or other jurisdiction of incorporation or organization: CO

    Transfer Agent: Standard Registrar and Transfer

    Investor contact: Corinne Allen, 505-988-5520

    -----------------------------------------------------------------------

    NEW APPROACH TO AIDS TREATMENT

  • Cytolin® is the first targeted immune therapy for HIV/AIDS that was shown to significantly reduce viral burden in preliminary human studies, according to CYDY. The potential advantage is that Cytolin® exerts its effect on the immune system and not the virus.
  • As a result, a species of virus resistant to the effects of Cytolin® cannot emerge through natural selection because the drug has no effects on the virus itself.
  • In addition to providing an additional treatment for the disease, Cytolin® might extend the useful life of the antiretroviral drugs currently used to treat HIV/AIDS, such as Emtriva® and Truvada® manufactured by Gilead (Nasdaq:GILD), Epzicom® and Lexiva® manufactured by GlaxoSmithKline (NYSE:GSK), and Reyataz® and Zerit® manufactured by Bristol-Myers Squibb (NYSE:BMY) to name a few.
  • How Cytolin helps fight HIV/AIDS (click)
  • Special report on Cytolin (pdf file, click)
  • MARKET & FDA FAST TRACK

  • There are a number of HIV patients in the U.S. that are in need of a "salvage therapy" which means that they have built up resistance to the antiviral cocktail therapies and have no other treatment options left to exercise.
  • Therefore, the FDA allows fast track status for salvage therapies to get drugs approved more quickly.
  • CLINICAL TRIAL RESULTS

  • Results from these clinical trials, discussed below, showed treatment with Cytolin was followed by a reduction in viral burden of up to one log with no severe adverse reactions.
  • The logarithm or "log" is the standard way of measuring the reduction in the amount of virus in the blood of HIV patients.
  • A reduction of one log, while from a preliminary study, is competitive with the approved AIDS drugs currently on the market.
  • CONTINUING CLINICAL TRIALS
    Anticipated Phase II (b) study

  • CYDY anticipates conducting a Phase II(b) pivotal study, which if successfully completed would allow the submission of a marketing application (Biologics Licensing Application; BLA.)
  • If the BLA were issued, CYDY would then be able to market Cytolin to certain HIV patients in
  • the United States.

    History

  • Phase I clinical trials were conducted by Symbion Research International under the sponsorship of Amerimmune, Inc. during 2002.
  • CYDY believes that the data from these trials support approval by the FDA of Phase II trials. CYDYpurchased the data from these trials from Symbion and will use the data to present to the FDA. (see ‘joint ventures’ below)
  • Projected costs

    to complete research and development and to obtain FDA approval of a Biologics Licensing Application:

    If the Phase II(b)I study is approved by the FDA, CYDY expects it, together with the pre-Phase II(b) efforts, to cost an estimated $2,050,000 to $3,350,000 for Symbion to conduct the clinical trials, plus estimated manufacturing and supply costs of $350,000 to $400,000 and $362,000 for the Phase Ia/b data for a total of $2,762,000 to $ 4,112,000.

    Timing
    anticipated completion dates and costs.

  • CYDY’s clinical trials can take anywhere from 29 to 42 months.
  • Completion of a Phase II(b) Pivotal Study would allow the submission of a marketing application and if approved, would allow CYDY to market Cytolin in the United States to certain HIV patients
  • Until CYDY has met with the FDA, which it hopes to do within the next two months, CYDY cannot be certain what additional studies, assuming that Phase II study supports the efficacy and safety of Cytolin, will be required to receive marketing approval.
  • If the Phase II study is approved by the FDA, we expect it, together with the pre-Phase II efforts, to cost an estimated $2,050,000 to $3,350,000 for Symbion to conduct the clinical trials, plus estimated manufacturing and supply costs of $350,000 to $400,000 and $362,000 for the Phase Ia/b data for a total of $2,762,000 to $ 4,112,000.
  • CYDY expects to complete research and development of all Cytolin clinical trials needed for approval of a marketing application if at all by December 2009.
  • JOINT VENTURES

    Timeway International

  • Has its principle offices in Phoenix, Hong Kong, Bejing, and Shanghai, and has joined with a select few U.S. biotech firms to bring a variety of advanced, non-competing medical technologies to the Chinese people, according to that Timeway’s profile and its President, Philip Liu.
  • The anticipated joint venture would develop Cytolin®, CytoDyn's targeted immune therapy for HIV/AIDS, in the populous and economically expanding Asian nation.
  • Symbion Research International

  • CYDY’s director, Peggy C. Pence, PhD., is President and Chief Executive Officer of Symbion Research International, Inc. On January 5, 2005, CYDY entered into a buy-sell agreement to purchase intellectual property owned by Symbion.
  • The agreement covers the Phase 1 clinical data and the protocol for the Phase II study. The results of the Phase II(b) stud(ies) for Cytolin shall be the sole property of CytoDyn, Inc upon Symbion's receipt of the final payment called for by this agreement.
  • Consulting Agreement with Jacob Lalezari, M.D.

  • CYDY has entered into a consulting agreement with Dr. Jacob Lalezari to consult on CYDY’s next clinical trials, including but not limited to, revising the protocol, conducting clinical trials as the principal investigator.
  • Dr. Lalezari is a successful AIDS doctor in the U.S who has conducted numerous clinical trials for large pharmaceutical companies such as, Glaxo (NYTE:GSK) , Human Genome Sciences (HGSI), ViTex, Pfizer (NYSE:PFE), Xcyte (XCYT), BMS, Roche (13th largest pharmaceutical company in the world, RHHBF.PK), and Aventis (NYSE:SNY).
  • CYCD believes Dr. Lalezari’s expertise and cooperation could help CYDY get this treatment approved the fastest, safest way possible.
  • Contract with Mayo Clinic:

    CYDY entered into a contract with Mayo Clinic to provide for the services of Dr. Donald W. Northfelt, the principal investigator of the Phase I trials, to participate in meeting with the FDA.

    Exploring Other Joint Ventures

  • While CYDY continues to pursue FDA approval of its Cytolin product, the company is also considering entering into joint ventures to develop other types of products.
  • For example, CYDY has entered into a nondisclosure agreement with another development stage biotech company to discuss the possibility of the joint development of drugs to treat neuropsychiatric diseases or disorders. These discussions are in the early stages and CYDY does not know if it will enter into a joint venture or other arrangement with this company or if any products might ensue from the efforts.
  • INTELLECTUAL PROPERTY & PATENTS

    Europe

  • During fiscal year 2004, several European patents were granted.
  • The new patents are covered by CYDY’s License Agreement with Allen D. Allen, CYDY president, that gives CYDY the exclusive right to develop his technology worldwide.
  • These patents are designated European Patent No. 94 912826.8, for the United Kingdom, Germany, France, Switzerland, Italy, the Netherlands, Portugal, Spain, and Sweden, and are the counterparts to our United States Patent No. 5424066.
  • Patents are pending in those same countries which, if granted, will be the equivalent of CYDY’s United States Patent No. 5651970.
  • Allen D. Allen’s patents (click)

    GROWTH PLAN

  • Meet with the FDA and seek approval to continue Phase II(b) clinical trials of Cytolin
  • Conduct the further clinical trials needed to get Cytolin to market
  • Continue efforts to protect CYDY technology by obtaining additional patents in The United Kingdom, the European Union and Hong Kong, raise additional capital, explore joint venture arrangements for other possible pharmaceutical products.
  • MANAGEMENT

    Allen D. Allen

    Mr. Allen has been chairman of our board and president and chief executive officer since October, 2003. Before joining CytoDyn, he was the chairman of the board of directors and chief executive officer of CytoDyn of New Mexico, Inc., since its inception in 1994. from 1990 to 1994 he was a research associate with Olive View-UCLA Medical Center where he collaborated and

    published with various medical professors oribinal research on HIV, dermatology and general immunology and was the co-investigator on an autologous vaccine study. From1986 to 1990 Mr. Allen was director of scientific affairs, Center for Viral Diseases, Northridge, California, where he conducted and published original research on a large cohort of patients with complex constellations of neuroimmunologic complaints. From 1971 to 1986 he was president of Algorithms, Incorporated where he conducted and published original research in the areas of

    artificial intelligence, perception, man and machine systems and societal engineering.

    Over the past thirty years, he has published numerous papers in the peer review science and medical journals. He has also served as an investigator on clinical research sponsored by major pharmaceutical companies, such as Ortho Biotech, Johnson & Johnson, and Sanofi-Winthrop. Mr. Allen invented and patented the family of HIV/AIDS therapies licensed to CytoDyn. He is a member of the American Physical Society and the American Federation of Scientists, a life

    member of the Institute of Electrical and Electronics Engineers, and a founding member of the Editorial Board of Physics Essays. Mr. Allen received an Associates of Arts degree from the University of California at Berkeley in 1957 and attended the University of California at Los Angeles from 1957 to 1959. In 1953 he received a national ARS Student Award in aeronautics from the American Rocket Society (now the Institute of Aeronautics and Astronautics). Mr. Allen is the father of Corinne E. Allen, Vice President of Business Development.

    Wellington A. Ewen, CPA, MBA.

    Mr. Ewen, has been chief financial officer since May 6, 2004. From 1988 until 2000, Mr. Ewen was owner of Wellington Ewen & Associates in Malibu, California, which represented many clients as financial and accounting consultants. He also served as financial and accounting officer

    for several development stage pharmaceutical companies, including Entropin, Inc. from April 1998 to June, 2000. From February, 1999 until his resignation in 2000, he was the chief financial officer of Amerimmune, Inc. From January, 2000 to July, 2000, he also served as a manager at PriceWaterHouseCoopers in Los Angeles, California. Mr. Ewen is currently licensed as a CPA in Oregon. He received his Bachelor of Science in 1963 and Master of Business Administration

    from Cornell University in 1964.

    Corinne E. Allen, CPA

    Ms. Allen has been a director and secretary and treasurer since October 2003, and was until May 2004, chief financial officer. In May 2004, Ms. Allen became the vice president of business

    development. From April 1995 to October 2003, she served as secretary and treasurer of CytoDyn of New Mexico, Inc. where she was also a director from June, 1994 to October 2003. Ms. Allen is a licensed Certified Public Accountant. From 1999 to 2003, Ms. Allen was employed as a senior manager at Deloitte & Touche, and, from 1992 to 1998 was a CPA at Hallquist Jones P.C. She has over 17 years experience in the accounting industry. Ms. Allen received a B.S. in

    Business Administration from California State University Northridge with a specialty in Accounting Theory and Practice in 1992. She has been a Certified Public Accountant since January 1997. Ms.Allen is the daughter of Allen D.Allen.

    Daniel M. Strickland, MD.

    Dr. Strickland has been a director of CytoDyn, Inc. since October, 2003. He served as a director of CytoDyn of New Mexico, Inc. from 1999 to October 2003. From 1995 to 1998 he practiced with Reproductive Endocrinologists, PC, Augusta, Georgia. From 1998 to the present he has practiced with the Women's Health Clinic in West Jefferson, North Carolina. From 1989 to 1995, Dr. Strickland was Chief, Reproductive Endocrinology, Ob-Gyn Services Division, Saudi Aramco Medical Services Organization in Dhahran, Saudi Arabia. From 1986 to 1989, Dr. Strickland served as Clinical Associate Professor at the University of Texas Health Science Center in San Antonio, Texas. Dr. Strickland served as a nuclear engineer for the U.S. Air Force before he became a physician. Dr. Strickland is board certified by the National Board of Medical Examiners. He received training designations from the American College of Surgeons, and the American Heart Association for Advanced Trauma Life Support and Advanced Cardiac Life Support. He holds U.S. patent No. 3,909,624 for a Split-Ring Marx Generator Grading. Dr. Strickland received a Bachelor of Science in Physics from the University of Georgia in 1966, and a Master of Science in Nuclear Engineering from the Air Force Institute of Technology in 1969. Dr. Strickland received his Doctorate of Medicine from Medical College of Georgia in

    1977.

    Vera J. Stecher, PhD, Director

  • Dr. Stecher has been a Clinical Director at Pfizer (NYSE: PFE) since 1994. From 1987 to 994 she was a project team leader at Sanofi-Winthrop, and from 1981 to 1987 she served as Section Head of Immunology at Sterling Winthrop Research Institute.
  • Dr. Stecher is the recipient of the Dr. Heinz Karger Memorial Prize for Biochemical Immunology as well as the New York University Founders' Award. Dr. Stecher is a member of many professional societies and has published numerous papers in the peer-review journals.
  • She holds a PhD with honors from the New York University Medical School, Department of Pathology, Immunology and Basic Medical Sciences. She also holds an M.S. degree from the University of Wisconsin, Zoology Department, Immunology/Biochemistry, and a B.A. (cum laude) from the University of Buffalo Biology Department.
  •  

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