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FORWARD LOOKING STATEMENTS
CytoDyn’s management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements are 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.
CYTOLIN®&
CYTODYNPrepared by
Nader Pourhassan, PhDChief Operating Officer
5099 Galen StreetLake Oswego , OR 97035
(503)[email protected]
Cytolin is the registered trademark name of our drug that our company, CytoDyn,
Inc. is developing.
CytoDyn, Inc. is the registered trademark name for our company which is a
Colorado corporation with its home office in Santa Fe, NM.
1) What is Cytolin?a) How it works
b) Why we need it now?c) Our strategy to get Cytolin approved by FDA
2 ) Who is CytoDyn?a) What is the stock worth now?
b) Future value (independent study)?C) Financials
1) Cytolin
a) How it works http://www.youtube.com/watch?v=nGrcNCE6jgg
b) Why we need it now? http://www.youtube.com/watch?v=vi--DTQX18A
1) Cytolin
c) Our strategy to get Cytolin approved by FDA
i) Proof of principle in MGHii) Then partner with a big Pharma
iii) Then clinical trail for FDA approval at MGH
1) Cytolin
c) Our strategy to get Cytolin approved by FDA
i) Proof of principle in MGHby Dr. Eric Rosenberg
Quick overview ofMGH
Massachusetts General Hospital, founded in 1811, is the third oldest general hospital in the United States.
With an annual research budget of nearly $550 million, MGH conducts the largest hospital-based research program
in the United States - a program that spans more than 20 clinical departments and centers across the hospital. This funding drives discoveries and breakthroughs in basic and
clinical research.
Each year, MGH is recognized for achieving the highest standards in education and research, ranking the hospital
among the most prestigious medical institutions.
The study is done in MGH by Dr. Eric Rosenberg
Dr. Rosenberg is an Assistant Professor of Medicine at Harvard Medical School, and staff Physician at MGH since 1995.
He also serves in the capacities of Associate Director of the Clinical Microbiology Laboratory.
He is the Director of the Education Unit of the Clinical Research Program at MGH.
Dr. Rosenberg has been co-chair, co-principal investigator, and principal investigator of clinical trials focused on HIV treatment, and
has been the beneficiary of several NIH awards.
He is Chair of the Treatment Working Group of the NIH Acute Infection Early Disease Research Program, and a member of the MGH Clinical
Research Council.
In relate to our Drug, Cytolin Dr. Rosenberg has an extensive background studying HIV.
Dr. Rosenberg is best known for his research on early HIV infection, also known as primary HIV infection.
Dr. Rosenberg important findings of immune control of HIV infection during structured treatment interruptions in primary infection were
previously published and highly cited in journals, including journal of Science and journal of Nature.
Dr. Rosenberg is board-certified in Internal Medicine and Infectious Diseases. His research and clinical practice is focused on the
immunopathogenesis of HIV infection. Dr. Rosenberg is a member of several professional societies and
associations, editorial board member of the Journal of Immune-Based Therapies and Vaccines, and Associate Editor of AIDS Clinical Care.
He is a regular presenter in the field of HIV infection and has published numerous articles in the literature.
Because of this amazing credentials of Dr. Rosenberg and MGH reputation, they are very selective of what drugs they
will research.
Dr. Rosenberg was contacted by his very close friend Mr. David Scondars from search for a cure in regard to Cytolin.
After Dr. Rosenberg reviewed the data for 188 patients treated with Cytolin, he requested extensive data and
opinions of other scientists familiar with Cytolin before he would make any recommendations.
Mr. Scondars did this research for Dr. Rosenberg and here is a brief summary of what was reported to Dr. Rosenberg
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.
About The Study
1) Cytolinc) Our strategy to get Cytolin approved by FDA
i) Proof of principle in MGHTo show why this drug worked on all 188 patients reported
for as long as 2 years with very little or no side effects?
ii) Then partner with pharmaSurely after seeing the credentials of MGH and Dr. Rosenberg one can
see why big pharmas will be inclined to partner with CytoDyn
iii) Then clinical trail for FDA approval at MGHWe have a new member to help us with this however big
pharmas will partner with us before that
2 ) CytoDyn, Inc.
a) What is the stock worth now?b) Future value (independent study)?
c) Financials
2 ) CytoDyn, Inc.a) What is the stock worth now?
What is CytoDyn doing to bring true value to its stocks?
In order to bring visibility to our stocks we met with RATIONAL 360
2 ) CytoDyn, Inc.a) What is the stock worth now?
Who is Rational 360?
Rational 360 partners are Russ Schriefer (former President Bill Clinton top campaign manager) and Patrick Dorton (former President George
W. Bush top campaign manager) Rational 360 partners have served as senior advisors to political leaders and campaigns on both sides of the aisle; their diverse
experience ranging from former President George W. Bush to Senator Tom Harkin [D-IA]. The combined firm is headquartered in
Washington, DC and has offices in Boston and Atlanta.The Stevens and Schriefer Group is a leading communications strategy firm known for powerful, effective, memorable advertisements that change public perceptions and advance clients’ agendas, ideas, and
philosophies.After our metting with Rational 360 they expressed their view about
CytoDyn….*)They agree to lower their fee from 28000/month to 7000 and accept
stocks of the company*) We were ready to have them go to work – BUT..
2 ) CytoDyn, Inc.b) Future value (independent study)?
We had an independent investment analysis done on our company by
HARBINGER RESEARCHby
Brian R. Connell, CFASenior Research Analyst
[email protected] Mr. Connell:
a) Has over 15 years experience in the securities industry ranging from CEO of StreetFusion
b) Holds degrees in Economics and Psychology from Duke University and is CFA Charter holder
c) He is associated with StreetCapital, an Atlanta-based broker-dealer
2 ) CytoDyn, Inc.b) Future value (independent study)?
This is few of what Harbinger Research, reported about CytoDyn
a) Extreme upside potentialb) This drug was used in humans and their viral load had
dropped 90% after initial usec) The manufacturing cost of Cytolin can be as low as $4.71
per dose- One year supply is maximum 24 doses
Harbinger concluded that stock should be around $20 right now – (but it is not)
Which will bring us to the last item, Financials
2 ) CytoDyn, Inc.c) Financials
In the last 12 months we have done 8 Qs and 2 10KsCurrently the auditors are working on last 2009 Qs
and 2010’s 10KAccording to the above timing of our Qs and 10Ks,
we could be caught up in less than 5 to 6 weeks if we only progress with the same rate as the above.
CytoDyn’sCurrent offering at 1.00and why we are having
such offering?
Funding of next study?
After getting FDA approval to conduct a Phase I/IIa trial, Allen D. Allen then licensed this product to a
company called Ammerimmune.
CYTODYN’s Scientific Advisory Board
1)Dorothy H. Bray, Ph.D,, Chair2)Robert H. Keller, M.D.3)Parviz Lalezari, M.D.
1) Dorothy H. Bray, Ph.D,, Chair
Dr. Bray has garnered extensive experience in the development of drugs for HIV/AIDS while serving in various senior positions at GlaxoSmithKline and its predecessors, a leading provider of antiretroviral drugs. She previously led an industry-driven international program of several hundred international studies of HIV/AIDS therapy, including over a hundred conducted in developing countries. Dr. Bray has been involved in multiple international research programs including the DART trial, the largest HIV therapy trial ever conducted in Africa, the CIPRA projects funded by the U.S. National Institutes of Health, as well as advising on multiple clinical development programs in biotech industry. Dr. Bray received her PhD from the School of Pharmacy at the University of London in 1988, and her Master of Science in Biology at the Jagiellonian University of Cracow, Poland in 1979.
2) Robert H. Keller, M.D., M.C., FACP, AAHIVS
Dr. Keller has been at the bedside of patients with HIV/AIDS since the beginning of the AIDS pandemic. His extensive experience in managing the disease gives Dr. Keller the important clinical insights that can only be gained through the practice of clinical medicine. Academically, Dr. Keller is a pioneer in the field of immunology. He received his M.D. with honors in 1970 from Temple University in Philadelphia, PA. From 1974 – 1976 he was a Fellow and Senior Fellow in the Department of Immunology at the Mayo Clinic in Rochester, NY, earning his Master of Science in Immunology from the same institution in 1976. During 1974 – 1976, he became Fellow and Senior Research Fellow in Immunology at the Mayo Clinic Foundation. In 1976, he was appointed Assistant Professor in Medicine at the University of Minnesota. From 1977 – 1980, Dr. Keller was an Assistant Professor in the Hematology/Oncology section of the Department of Medicine at the Medical College of Wisconsin in Milwaukee, WI. From 1979 – 1982 he was also a Clinical Associate Professor of Hematology, Immunology and Flow Cytometry at the Department of Health Services at the University of Wisconsin in Milwaukee, and from 1980-1982 was Director of Immunology at the Midwest Children’s Cancer Center in the same city. In 1986 Dr. Keller relocated to Hialeah, FL to serve as Associate Director of Research and Development at Coulter Immunology, a leading supplier of flow cytometers and reagents. Subsequently, he established his medical practice in Florida, and since 1998 has served as a Voluntary Adjunct Professor at the Miller School of Medicine, University of Miami, in Miami, FL.Dr. Keller is the author of over 100 peer review research and clinical articles. He has served on the Editorial Boards of Diagnostic Immunology (1986 – 1990), Journal of Leukocyte Biology (1984 – 1986) and Interventions in Aging (2005). His many honors include the Humanitarian of the Year Award from the National Hemophilia Federation, and election to the Board of Governors of the Florida Chapter of the American Academy of HIV Medicine. Dr. Keller was also voted one of America’s top physicians in internal medicine, immunology and hematology by the Consumer’s Research Council of America.For Full Curriculum Vitae please go to www.cytodyn.com
3) Parviz Lalezari, M.D.
Dr. Lalezari has been an Attending Physician at the Montefiore Medical Center, Bronx, N.Y. since 1972 and a Clinical Professor of Medicine at the Albert Einstein College of Medicine, likewise in
the Bronx, since 1996. In addition, he has held an appointment at the latter institution as Clinical Professor of Pathology since 1996. Previously, he served at Montefiore as Head of the Division of Immunohematology and Director of the Blood Bank. At the Albert Einstein College of Medicine
Dr. Lalezari previously served as a Professor of Medicine and Professor of Pathology. He has served on the Editorial Board of Blood, the American Journal of Hematology, and several other respected peer-review journals. A member of the New York Academy of Sciences, Dr. Lalezari
served as Chairman for the First National Conference on Organ Specific Antigens in 1979 and the NIH Ad Hoc Study Section on Transplantation Immunology in 1980. He is the author of numerous
research papers published in the peer-review journals. Bibliography available at www.cytodyn.com
After the discovery of antiviral drugs, Cytolin was
inappropriately ignored
Although antiviral drugs initially seemed to be the answer to all of the problems in the world of AIDS, reports of resistance to antiviral drugs have been
shifting the focus back on Cytolin.
Financial Times (ft.com) reports:
The current approach to treatment in the developing world is contributing to growing drug resistance, warns Prof Clumeck, head of infectious diseases at Belgium’s St-Pierre University
Hospital. “We are creating a virological time bomb.”Drug resistance is of concern because the spiraling economic burden of HIV, the escalating costsand difficulties of using alternatives and the increasing likelihood of a resistant virus spreadingacross Africa and beyond come just as the research for new drugs and prevention techniques risks losing momentum. With 3m patients in low- and middle-income countries receiving antiretroviral therapy (ART) for HIV, the rising absolute numbers carrying resistant strains of the virus have important implications for governments in poor countries – as well as for richer ones that receive immigrants and sponsor treatment in their countries of origin. The issue is triggering growing international attention. David Heymann, an assistant director general of the World Health Organization, told a UK House of Lords committee recently: “We have drugs going out in massive quantities ... and there are not systems in countries that are [in place and are] monitoring resistance to these drugs.”
Financial Time (ft.com) reports: “A worrying number of patients in sub-Saharan Africa who need ART are lost from treatment programs,” concluded the researchers from
Boston and Johannesburg, who argued that true retention rates might be lower still because clinicians with more disappointing results are less
likely to publish them.
Latest News on CYTODYNJune 5, 2008
CytoDyn to Meet with Quest Clinical Research to finalize Phase II Strategy for Novel AIDS Drug.
CytoDyn to Meet With Quest Clinical Research to Finalize Phase II Strategy for Novel AIDS DrugLos 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.
Latest News on CYTODYNDecember 19, 2008
CytoDyn Launches Feasibility Study in China
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.
CytoDyn Launches Feasibility Study in China
Latest News on CYTODYNMay 11, 2009
Independent TV Producer Taping Documentary About CytoDynLos 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).
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.
Latest News on CYTODYNOctober 8, 2009
CytoDyn Transfers Research on Unique AIDS Drugto Massachusetts General Hospital
Santa Fe, NM ― October 8, 2009 ― In response to new economic and regulatory realities, CytoDyn, Inc. (Pink Sheet: CYDY) has made a sea change in its strategy for developing Cytolin®, the Company’s unique immune therapy for treating HIV/AIDS. Studies of the drug will be designed and conducted by Massachusetts General Hospital, one of the premier teaching hospitals in Boston, Massachusetts, as part of its mission to advance medical knowledge and treatments through research, education and patient care.The Current Standard for Treating HIV/AIDSDuring 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.
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.
About The Study
