ISMAIL ABDUL FATTAH AGREES TO BECOME CYTODYN'S SENIOR ADVISOR OF BUSINESS DEVELOPMENT FOR THE MIDDLE EAST
Lutz, Florida, January 18, 2012 – CytoDyn Inc. (the "Company")(OTC QB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, and other antibody applications, announced today that Ismail Abdul Fattah will serve as the Company's Senior Advisor of Business Development for the Middle East. Mr. Fattah will continue to serve in his role with AM Financials s.a.l, in Beirut, Lebanon. As part of the Company's evolution and international business development activities, Mr. Fattah will work in conjunction with Dr. Nadar Pourhassan, the Company's Managing Director of Business Development, to expand the Company's business development activities in the Middle East.
"The Company is pleased and honored to have Mr. Fattah advising on sponsorship and business development opportunities in the Middle East," commented Kenneth J. Van Ness, President and Chief Executive Officer of the Company.
"I am optimistic that my experience will complement the Company as it progresses its scientific and business opportunities in the Middle East, and I look forward to expanding our relationship in the future," commented Mr. Fattah.
Forward Looking Statements
The Press Release includes forward-looking statements and includes forward-looking information within the meaning of United States securities laws. These statements and this information represent the Company’s intentions, plans, expectations and beliefs, and are subject to risks, uncertainties and other factors, of which many are beyond the Company’s control. These factors could cause actual results to differ materially from such forward-looking statements or forward-looking information. The words "believe," "estimate," "expect," "intend," "attempt," "anticipate," "foresee," "plan," and similar expressions and variations thereof, identify certain of such forward-looking statements or forward-looking information, which speak only as of the date on which they are made. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or on this forward-looking information.
For more information please contact:
Douglas E. Jacobson
Controller
(813) 527-6969
Lutz, Florida, January 12, 2012 - CytoDyn Inc. (the "Company")(OTC QB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency virus and other antibody applications, announced today that it is presenting an update on its Human Immunodeficiency Virus ("HIV") and Feline Immunodeficiency Virus ("FIV") therapeutic antibody programs, including new preclinical findings, at the Therapeutic Potential of Antibodies for HIV meeting sponsored by Search For A Cure, Inc. in Boston, Massachusetts.
The meeting, co-sponsored by the Massachusetts Department of Public Health, will bring together a distinguished panel of speakers from public and private sector institutions, including the National Institute of Health, to discuss the therapeutic potential of monoclonal antibodies for HIV treatment.
Dr. Richard Trauger, Managing Director of Science at the Company, will present an overview of Cytolin®, the Company’s lead monoclonal antibody for the treatment of HIV. Specifically, Dr. Trauger will discuss confirmation of the specificity of Cytolin® for selected blood cells, its unique binding site on its target antigen, CD11a, its ability to bind directly to HIV, and its lack of immunosuppression of HIV-specific cytotoxic T-cell ("CTL") activity. Dr. Trauger will also present a short summary of the clinical experience from a previous compassionate use study in HIV-infected subjects.
In addition, Dr. Trauger will be presenting new preliminary findings regarding CytoFeline™, a monoclonal antibody developed for the treatment of FIV. Tests of a panel of anti-LFA1 antibodies against FIV infection in tissue culture showed that certain of these antibodies can block FIV infection. Thus, the Company's original premise that this technology may provide a way to inhibit infection appears to warrant continued developmental research.
The CytoFeline™ research was performed in the laboratory of Dr. John Elder, Professor in the Department of Immunology and Microbial Science at The Scripps Research Institute. "Our preliminary findings are very promising. We can now proceed with additional efficacy tests to determine the practicality of anti-LFA1 antibodies to lower viral loads in FIV-infected cats," commented Dr. Elder.
The Company will select a research cattery to perform the additional efficacy tests of CytoFeline™. "We are excited to continue to explore the FIV model as a stand-alone opportunity and as a model for HIV," commented Kenneth J. Van Ness, President and Chief Executive Officer of the Company.
The Press Release includes forward-looking statements and includes forward-looking information within the meaning of United States securities laws. These statements and this information represent the Company’s intentions, plans, expectations and beliefs, and are subject to risks, uncertainties and other factors, of which many are beyond the Company’s control. These factors could cause actual results to differ materially from such forward-looking statements or forward-looking information. The words “believe,” “estimate,” “expect,” “intend,” “attempt,” “anticipate,” “foresee,” “plan,” and similar expressions and variations thereof, identify certain of such forward-looking statements or forward-looking information, which speak only as of the date on which they are made. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or on this forward-looking information.
While it is impossible to identify or predict all such matters, these differences may result from, among other things, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and product candidates, including the risks that clinical trials will not commence or proceed as planned; products appearing promising in early trials will not demonstrate efficacy or safety in larger-scale trials; future clinical trial data on our products and product candidates will be unfavorable; the Company's products will not receive marketing approval from regulators or, if approved, do not gain sufficient market acceptance to justify development and commercialization costs; competing products currently on the market or in development might reduce the commercial potential of the Company's products; the Company, its collaborators or others might identify side effects after the product is on the market; or efficacy or safety concerns regarding marketed products, whether or not originating from subsequent testing or other activities by the Company, governmental regulators, other entities or organizations or otherwise, and whether or not scientifically justified, may lead to product recalls, withdrawals of marketing approval, reformulation of the product, additional pre-clinical testing or clinical trials, changes in labeling of the product, the need for additional marketing applications, or other adverse events.
The Company is also subject to risks and uncertainties associated with the actions of its corporate, academic and other collaborators and government regulatory agencies, including risks from market forces and trends; potential product liability, intellectual property, litigation, environmental and other risks, the risk that the Company may not be able to enter into favorable collaboration or other relationships or that existing or future relationships may not proceed as planned, the risk that current and pending patent protection for the Company's products may be invalid, unenforceable or challenged, or fail to provide adequate market exclusivity, and the uncertainty of the Company's future profitability.
Risks and uncertainties also include general economic conditions, including the availability of capital; changes in generally accepted accounting principles; the impact of legislation and regulatory compliance; the highly regulated nature of the Company's business, including government cost-containment initiatives and restrictions on third-party payments for the Company's products; trade buying patterns; the competitive climate of the Company's industry; and other factors set forth in the Company's Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission. In particular, the Company cannot assure you that Cytolin® or CytoFeline™ will be commercially successful or be approved in the future in other formulations, indications or jurisdictions, or that any of the Company's other programs will result in a commercial product.
By letter dated January 3, 2012, the Division of Enforcement of the Securities and Exchange Commission (the "SEC") notified CytoDyn Inc. (the "Company") that the SEC had completed its informal investigation of the Company that was previously disclosed in a Form 8-K filed by the Company on July 21, 2011. The SEC is recommending no enforcement action be taken against the Company.
Lutz, Florida, December 20, 2011 – CytoDyn Inc, ("the Company")(OTC QB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency virus and other antibody applications, announced today that the board of directors of the Company unanimously approved the addition and election of Anthony D. Caracciolo to serve as a member of the Company's board of directors.Mr. Caracciolo was formerly employed at Gilead Sciences, Inc. ("Gilead"), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need, from 1997 until retiring in October of 2010. During his tenure, Mr. Caracciolo served as Senior Vice President, Manufacturing and Operations and was a senior member of Gilead's executive committee, which was responsible for the strategic and operational direction of Gilead. During Mr. Caracciolo’s tenure at Gilead, Gilead grew from 300 employees to approximately 4,000 worldwide, with commercial activities in 38 countries. In addition, Gilead's sales rose from $200 million to over $7 billion. While at Gilead, Mr. Caracciolo had responsibilities of directing operational and strategic imperatives for two manufacturing sites, development of a portfolio of contract manufacturing organizations, producing over fifty percent of Gilead’s commercial products, informational technology, compliance assurance associated with aseptic processing, product development, optimization, technology transfers, and supervision of over 600 employees at six global locations.
"The Company is very fortunate to have Mr. Caracciolo join our board of directors, and as the Company continues to evolve, improve and develop its strategic capabilities, the Company will benefit from Mr. Caracciolo's broad experience and knowledge," commented Kenneth J. Van Ness, President and Chief Executive Officer of the Company.
Forward Looking Statements The Press Release includes forward-looking statements and includes forward-looking information within the meaning of United States securities laws. These statements and this information represent the Company’s intentions, plans, expectations and beliefs, and are subject to risks, uncertainties and other factors, of which many are beyond the Company’s control. These factors could cause actual results to differ materially from such forward-looking statements or forward-looking information. The words “believe,” “estimate,” “expect,” “intend,” “attempt,” “anticipate,” “foresee,” “plan,” and similar expressions and variations thereof, identify certain of such forward-looking statements or forward-looking information, which speak only as of the date on which they are made. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or on this forward-looking information. ________________________________________For more information please contact: Douglas E. Jacobson Controller (813) 527-6969 v
Information is available on the Company's Form 10QA for the quarter ended August 31, 2011 filed November 29, 2011.
Information is available on the Company's Form 10Q for the quarter ended August 31, 2011 filed November 21, 2011.
Lutz, Florida, November 16, 2011 – CytoDyn Inc. (the “Company”) (OTC:CYDY.PK), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that it has entered into a Research Funding and Option Agreement (the "Agreement") with The Scripps Research Institute ("Scripps Research"), a nonprofit institution, that will enable Dr. John H. Elder, Professor in the Department of Immunology and Microbial Science at Scripps Research, to explore the potential application of the Company's recently provisionally patented technology (which the Company has applied to trademark as CytoFeline) as an effective therapy in the treatment of feline immunodeficiency virus ("FIV"). Dr. Elder is a leading FIV researcher, having researched and published his findings on FIV for more than 20 years. The Company has assigned the Agreement to its wholly owned subsidiary, CytoDyn Veterinary Medicine LLC.
FIV has been reported to cause an AIDS-like syndrome in the domestic cat and is a distant relative of HIV, the cause of AIDS in humans. The world-wide prevalence of FIV infections is estimated to be 1-4%, or potentially 6 million + cats in the top 10 countries reporting cat populations. The number is considerable larger if feral cats are included in the calculation.
In addition to the domestic and feral cats, the Company intends to study whether CytoFeline may potentially benefit the large cat population, specifically lions, tigers and other big cats found in zoos. "As we move forward on our research and development, one area of interest and study could be the possible application to the declining wild tiger and lion populations, especially the Russian Tigers," commented Kenneth J. Van Ness, President and Chief Executive Officer of the Company.
The Company believes that currently there is no satisfactory therapeutic treatment for FIV on the market. The Company believes that many drugs available for HIV treatment do not work against FIV or are too toxic for cats, leaving virtually no effective treatment for the cat virus.
“CytoDyn hopes that its proprietary technology for HIV/AIDS has potential for the treatment of FIV,” comments Kenneth J. Van Ness. Mr. Van Ness further comments, “Dr. Elder’s expertise and experience in FIV research will contribute to our efforts to apply our existing monoclonal antibody technology platform in HIV/AIDS to FIV.”
The Company recently filed its first provisional patent application for use of anti-adhesion molecule therapies to treat FIV infections, and has identified three candidate antibodies that the Company hopes have potential for activity in the feline system. If the results of research warrant doing so, the Company likely would file at some point in the future, an investigational new drug application with the U.S. Food and Drug Administration.
“This is an exciting and novel avenue for exploring the development of a new antiviral agent for possible treatment of FIV infections. In addition to the potential for alleviating ongoing infections, if our findings support our current hypothesis, this new treatment could lower the virus burden and decrease the risk of an infected cat spreading the infection to uninfected cats,” added Dr. Elder.
CytoDyn Inc amended its bylaws related to filings under Regulation S. Information is available on the Company's Form 8K filed November 10, 2011.
Information is available on the Company's Form 10K filed November 4, 2011.
Information is available on Company's 10Q for the quarter ended February 28, 2011 filed October 14, 2011.
CYTODYN ANNOUNCES HUMANIZED CYTOLIN® PROVISIONAL PATENT APPLICATION FILED FOR THE TREATMENT OF HIV/AIDS
Lutz, Florida, September 23, 2011 – CytoDyn Inc. (the “Company”) (OTC:CYDY.PK), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, HIV/AIDS, announced today that it has filed a provisional patent application in the United States for its humanized version of its lead product Cytolin®, a monoclonal antibody for the treatment of HIV infection. According to Dr. Richard Trauger, a co-inventor on the provisional patent application and Managing Director of Science of the Company, “The provisional patent application discloses the use of a humanized version of Cytolin®. We hope this invention will not only allow for the treatment of HIV infection but also for the potential inhibition of HIV infection. If issued, we believe the patent will further strengthen the Company's intellectual property portfolio.” Kenneth J. Van Ness, President and Chief Executive Officer of the Company commented that, “we are pleased to have reached this significant milestone for the Company. We believe this new antibody provides the Company with a clinical candidate for Phase I testing and will be supplied to Dr. Eric S. Rosenberg at Massachusetts General Hospital ("MGH"). The Company anticipates that the humanized version of the monoclonal antibody will be included in the extended study that the Company is funding at MGH regarding the potential mechanism of action of Cytolin®.”
Information is available on Company's 10Q/A for the quarter ended November 30, 2010 filed September 9, 2011.
Information is available on Company's 10Q/A for the quarter ended August 31, 2010 filed August 22, 2011.
Information is available on Company's 10K/A filed August 5, 2011.
Lutz, Florida, August 4, 2011 – CytoDyn Inc. (the “Company”) (OTC:CYDY.PK) announced today that on June 17, 2011 it filed for a provisional patent in the United States for the treatment of FIV, a retroviral infection in cats. The Company intends to develop this product as part of its wholly owned subsidiary CytoDyn Veterinary Medicine, LLC which the Company hopes will allow it to expand its science into a different market segment. The Company’s primary target will be a monoclonal antibody for the treatment of FIV infection in cats. According to Kenneth J. Van Ness, the Company’s President and Chief Executive Officer, “we believe our technology may allow us to target cell derived molecules that the Company thinks may be essential for retroviral infections.” The Company anticipates it will apply to trademark this product under the name CytoFeline. This information is available on the Company's 8K filed August 4, 2011.
The press release includes forward-looking statements and includes forward-looking information within the meaning of United States securities laws. These statements and this information represent the Company’s intentions, plans, expectations and beliefs, and are subject to risks, uncertainties and other factors, of which many are beyond the Company’s control. These factors could cause actual results to differ materially from such forward-looking statements or forward-looking information. The words “believe,” “estimate,” “expect,” “intend,” “anticipate,” “foresee,” “plan,” and similar expressions and variations thereof, identify certain of such forward-looking statements or forward-looking information, which speak only as of the date on which they are made. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or on this forward-looking information.
Douglas Jacobson
813 527-6969
CYTODYN ANNOUNCES NEW BOARD CHAIRMAN
Lutz, Florida, July 21, 2011 – CytoDyn Inc. has been notified by the Division of Enforcement of the Securities and Exchange Commission (the “SEC”) that it had initiated an informal inquiry into matters including, but possibly not limited to, the facts and circumstances surrounding the issues disclosed in the Company’s Form 8-K filed on March 16, 2011. The Company has been and intends to continue cooperating fully with the SEC in connection with this inquiry.
Lutz, Florida, July 18, 2011. In late June, 2011, Allen D. Allen, who is 75, informed CytoDyn Inc. (the "Company") that he was contemplating retiring from the Company as its Chief Technical Officer and also resigning from the Company's Board of Directors (the "Board") and as the Chairman of the Board. Mr. Allen has been a long-time valuable member of the Company's Board of Directors and the Company believed it would benefit from Mr. Allen continuing in some capacity with the Company as set forth below. Mr. Allen resigned as an officer and director effective July 14, 2011. Ken Van Ness, President, Chief Executive Officer and member of the Board of the Company, expressed the thanks of the Company, saying, "We are grateful to Mr. Allen for his years of service to the Company and he is an important component of the Company's history." In connection with Mr. Allen's retirement and resignation, the Company and Mr. Allen entered into a consulting agreement (the "Agreement"). The Agreement has a two year term and will require the Company to pay Mr. Allen $150,000 in the first 12 month period of the Agreement and $125,000 in the second twelve month period of the Agreement in exchange for certain consulting services Mr. Allen will provide to the Company. The foregoing summary of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, which has been attached to our Form 8K filing of this date as Exhibit 10.1 and is incorporated herein by reference.
Additional information available on 8K filed July 18, 2011
Lutz, Florida, July 5, 2011 CytoDyn Inc. (the "Company") (OTC:CYDY.PK) announced that Nader Pourhassan, PhD, has accepted the challenge of becoming the new Managing Director of Business Development of the Company, effective as of June 30, 2011, and will no longer act as the Company's Chief Operating Officer, effective as of June 30, 2011. The Company is pleased that Dr. Pourhassans new focus will be to help advance the development of the Company's current and future business relationships worldwide. Dr. Pourhassan commented, "After spending approximately three years as the Chief Operating Officer of the Company, the new management and leadership has provided me a platform to expand and develop the Company's story worldwide." "No position could be more exciting and challenging, I am looking forward and am very pleased to accept the challenge", commented Dr. Pourhassan. Dr. Pourhassan accepted this position at the request of Kenneth J. Van Ness, President and Chief Executive Officer of the Company. The Company believes that Dr. Pourhassan will bring his enthusiasm and commitment to the future success of the Company in this challenging position.
The Press Release includes forward-looking statements and includes forward-looking information within the meaning of United States securities laws. These statements and this information represent the Companys intentions, plans, expectations and beliefs, and are subject to risks, uncertainties and other factors, of which many are beyond the Companys control. These factors could cause actual results to differ materially from such forward-looking statements or forward-looking information. The words "believe," "estimate," "expect," "intend," "anticipate," "foresee," "plan," and similar expressions and variations thereof, identify certain of such forward-looking statements or forward-looking information, which speak only as of the date on which they are made. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or on this forward-looking information.
Douglas E. Jacobson Controller (813) 527-6969
Lutz, Florida July 1 2011. Cytodyn is pleased to announce its new website www.cytodyn.com. The new website will allow viewers to obtain information on the company as it continues to develop and evolve its science and business. Additional information is available on 8k filed July 1 2011.
Lutz , Florida June 15, 2011. CytoDyn relocated its corporate office to Lutz Florida, effective June 15,2011. This relocation will reduce costs and allow the company to benefit from executive, accounting, shareholder services, and legal functions to be consolidated to one location. Additional information is available on 8k filed June 15, 2011.
Santa Fe, New Mexico, May 24, 2011 CytoDyn Inc. (the "Company") (OTC:CYDY.PK) announced that it is providing additional funding to extend the current study being conducted by Dr. Eric S. Rosenberg at Massachusetts General Hospital. Details can be found at www.clinicaltrials.gov by entering "Cytolin®." The Company's decision to extend the study was based on discussions with Dr. Rosenberg and a review of the existing data. "We are pleased that Dr. Rosenberg has completed his initial analysis regarding the potential mechanisms of action of Cytolin®, and given the data set to date, a decision was made by the Company and Dr. Rosenberg to extend the study,"said Kenneth J. Van Ness, President and CEO of the Company. The extension will allow Dr. Rosenberg to further explore the initial findings regarding the potential mechanism of action. "We look forward to continuing our studies with the Company assessing the mechanism of action of Cytolin®," said Dr. Rosenberg.
The Company had previously disclosed that the study would be completed in January 2011, with the results to be reported at the discretion of Dr. Rosenberg. The Company's agreement and this extension will allow Dr. Rosenberg to report initial results and any subsequent supporting data at his discretion and timeline. The Company anticipates the extended study to be completed in the 4th quarter 2011 although there is not a contractual obligation to do so in that timeframe.
The Press Release includes forward-looking statements and includes forward-looking information within the meaning of United States securities laws. These statements and this information represent the Company's intentions, plans, expectations and beliefs, and are subject to risks, uncertainties and other factors, of which many are beyond the Company's control. These factors could cause actual results to differ materially from such forward-looking statements or forward-looking information. The words "believe," "estimate," "expect," "intend," "anticipate," "foresee,""plan,"and similar expressions and variations thereof, identify certain of such forward-looking statements or forward-looking information, which speak only as of the date on which they are made. In particular, statements relating to the completion of the extended study are forward-looking statements and forward-looking information. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or on this forward-looking information.
Santa Fe, NM April 14, 2011 - CytoDyn Inc. (CYDY: OTCQB) (the "Company") has appointed Andrew T. Libby, Jr. to fill the vacancy of Chief Financial Officer and to serve as Corporate Secretary.
"I am honored to become Chief Financial Officer and Corporate Secretary and to help move CytoDyn forward in its evolution and development. I welcome this opportunity to work with the Company and to contribute my experience in nutraceuticals and medical product distribution towards the Company's success. We have a lot to do, and I am intensely focused on building shareholder value," said Mr. Libby.
"As part of the Company's continuing development and evolution we are pleased to be adding an experienced financial and operational professional to the senior management team. Mr. Libby will have my full support and I look forward to Andy's professional contributions to the Company," said Kenneth J. Van Ness, President and CEO of the Company.
Mr. Libby has over 35 years of professional experience in managing financial and operational aspects of private companies, public agencies and publicly traded companies. Mr. Libby has expertise in strategic planning for companies involved in the research, manufacture and distribution of nutraceutical and healthcare products. Mr. Libby has served, and will continue to serve, as Senior Vice-President and Chief Financial Officer of the Tampa Housing Authority for seven years. Prior experience includes serving seven years as a Director of the medical faculty practice at USF College of Medicine, where he was directly involved with the financing and monitoring of over 200 pharmaceutical grants. Prior experience also includes serving at the executive level in local government and serving on the accounting faculty of the Business University of Tampa. Mr. Libby received an MBA and Post-Graduate Certificate in Accounting from the University of Tampa and BA degrees in both Accounting and Management from the University of South Florida. Mr. Libby holds an active license in Florida as a Certified Public Accountant and is a Certified Internal Auditor.
This announcement contains forward looking statements related to the Company's future growth and development. The Company wishes to advise readers that a number of important factors could cause actual results to differ materially from those anticipated in such forward-looking statements including, but not limited to, government regulation, managing and maintaining growth, 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 -January 5, 2011 - CytoDyn, Inc. (OTCQB:CYDY) today announced the appointment of Richard J. Trauger, PHD to the position of Director of Scientific Information.
"As part of the ongoing CytoDyn evolution we are excited about having Dr. Trauger join the scientific and business development teams", said Kenneth J Van Ness president and CEO of CytoDyn.
Dr. Trauger received his Ph.D. in 1986 from the University Of South Carolina School Of Medicine in retrovirology. After completing his post-doctoral studies at the Scripps Research Institute in La Jolla, Dr Trauger joined The Immune Response Corporation as Associate Director of Immunology, where he worked with Dr. Jonas Salk on the development of an immune-based therapy for HIV infection. In addition to his research duties, Dr. Trauger also functioned as the company's Scientific Liaison and was the company's point of contact to the scientific, financial and activist communities.
In his last position as Senior Director of Cancer and Infectious Disease at Hollis-Eden Pharmaceuticals, Inc. Dr. Trauger was the project and program manager for the company's lead anti-cancer drug and directed that program from discovery to the initiation of a multi-center Phase I clinical trial for late stage prostate cancer. Dr Trauger continued his efforts in corporate communications and business development at Hollis Eden, working extensively with scientific and financial communities both in the US and abroad.
The prior experience and responsibilities of Dr. Trauger in assessing humoral and cellular immunity to HIV and in the development of novel vaccines and gene therapy strategies provide a valuable asset to CytoDyn.
According to Dr. Trauger, "CytoDyn's lead drug, Cytolin®®, could provide a novel option for the treatment of HIV disease. I look forward to the challenge of helping take this concept to the clinic."
Dr. Trauger will work in collaboration with Allen D. Allen, CytoDyn's founder, Chairman, and Chief Technical Officer, to continuously review future applications of CytoDyn's technology.
"CytoDyn is very fortunate to be able to add Dr. Trauger and his related scientific experience to our continuing development," said Kenneth J Van Ness, CEO.
Certain statements contained herein may include "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are not historic facts but anticipate future events andcircumstances. Such forward-looking statements include 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. Factors that could cause actual results to differ materially include, among others, government regulation, managing and maintaining growth, and the effects of adverse publicity, litigation, competition, and other factors that may be identified in the Company's annual report on Form 10-K for the fiscal year ended May 31, 2010 and other filings with the Securities Exchange Commission under the caption "Risk Factors."
Welcome, to the continuing evolution and development of CytoDyn. We have as a company a unique and once in a lifetime opportunity to possibly impact the HIV/AIDS problem facing the world.
Before we look to the future we have to acknowledge our past. The evolution of a small biotech/pharma company is never easy. Evolution presents many challenges and potential conflicts between shareholders, management, and the development of its science. Some shareholders want immediate results, which are not usually realistic. The easy way would have been to raise money and dilute the initial and existing shareholders that believed in the science and the potential of our one-of-a-kind drug, Cytolin®®. A path CytoDyn did not take.
As CytoDyn moves our primary drug Cytolin®® through the continuing process of development and FDA approval, there will be challenges, but with challenges there are also opportunities.
In the evolving future, CytoDyn will be adding key management and staff, engaging additional experienced legal counsel, evaluating investment banking relationships, updating our website, and constantly evaluating our potential relationships with big pharma. As we move forward we will also be increasing the exposure of our current drug Cytolin®®, with new public and institutional awareness.
For shareholders looking to the future, you will also see additions to our board of directors and the formation of a new scientific advisory board.
My focus as CytoDyn's new President and CEO is to constantly improve CytoDyn's operating position, science, and to continue to improve and build shareholder value.
We as a company will diligently pursue the business opportunities as presented that will eventually benefit both shareholders and the world.
Thank you in advance for your participation in the future of CytoDyn.
Regards
Kenneth J Van NessPresident and CEO
Certain statements contained herein may include "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are not historic facts but anticipate future events and circumstances. Such forward-looking statements include 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. Factors that could cause actual results to differ materially include, among others, government regulation, managing and maintaining growth, and the effects of adverse publicity, litigation, competition, and other factors that may be identified in the Company's annual report on Form 10-K for the fiscal year ended May 31, 2010 and other filings with the Securities Exchange Commission under the caption "Risk Factors."
Santa Fe, NM - December 9, 2010 - The Board of Directors of CytoDyn, Inc. (Pink Sheets:CYDY) has elected current director Kenneth J Van Ness President and CEO. Mr Van Ness succeeds Allen D Allen, current Chairman, President and CEO. Mr Allen will remain Chairman.
"I am honored to become President and CEO and to help move CytoDyn forward in its evolution and development." said Mr.Van Ness. "The shareholders need to be proud of what CytoDyn and Al Allen have accomplished so far in its development. CytoDyn has pioneered, a unique monoclonal antibody, Cytolin®®, for the treatment of HIV/ AIDS, and this product has tremendous potential," said Mr. Van Ness.
"CytoDyn will continue to refine and develop a collaborative effort to move our primary, one-of-a-kind drug, Cytolin®®, to the completion of its necessary clinical trials. CytoDyn has reached a point in our business cycle where we need to develop and evaluate all aspects of our business. I am looking forward to interacting and developing investment banking and related PHARMA relationships" comments Mr. Van Ness.
"I welcome this opportunity to work with my colleagues and Board and to lead this Company successfully into the future. We have a lot to do, and I am intensely focused on building shareholder value." said Mr.Van Ness.
"Mr Van Ness will have my full support, and I am confident that Ken will deliver a new era of growth for our shareholders." said Mr Allen, Chairman and founder of CytoDyn.
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, 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 - 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.
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.
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.
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.
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.
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.
