3 articles on a New AIDS Drug To Undergo Clinical Trials

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Yonkers, New York Advanced Viral Research Corp. announced Monday that it has received approval from the Food and Drug Administration for clinical trials on a new generation of drugs known as AVR118. After review of the drug which was submitted at the end of November, the FDA notified the Company that it may proceed with its Phase II, multi-center clinical trial in the U.S.

The study will examine the safety, tolerability and efficacy of AVR118 in patients with advanced cancer who are suffering from symptoms of progressive disease. Successful completion of this trial will then provide the platform to conduct further studies in patients with other complications of cancer.

ADVR's AVR118 is a biopolymer that possesses novel immunomodulator activity. This peptide-nucleic acid complex, which, to date, has demonstrated a very favorable safety profile, appears to stimulate the pro-inflammatory responses required to combat viral infections such as HIV and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis.

Data presented at the American Society of Clinical Oncology's annual meeting in June, 2004, showed that AVR118 appears to have activity against fatigue, loss of appetite, and weight loss in patients with HIV.

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Investigational New Drug Application for AVR118 Under Review

Monday, November 29 2004 @ 07:41 AM ESTContributed by: tberberabe

Advanced Viral Research Corp. announced that it submitted an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) last week to initiate a clinical development program for the systemic use of AVR118 in patients with advanced malignancies.YONKERS, N.Y.--(BUSINESS WIRE)--Nov. 29, 2004--Advanced Viral Research Corp. (OTC Bulletin Board: ADVR - News) announced that it submitted an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) last week to initiate a clinical development program for the systemic use of AVR118 in patients with advanced malignancies. "Submission of the IND for AVR118 represents a major milestone for the Company as it is a critical step in the commercial development of AVR118," said Dr. Elma Hawkins, President and CEO of Advanced Viral Research Corp. "We are eager to gain clinical exposure with the systemic use of AVR118 in the U.S. Successful development of AVR118 could offer a new option for treating the symptoms of advanced cancer." The first clinical trial is a Phase II, multi-center study and will be conducted in the U.S. The trial will examine the safety, tolerability and efficacy of AVR118 in patients with advanced cancer who are suffering from symptoms of progressive disease. Successful completion of this trial will then provide the platform to conduct further studies in patients with other complications of cancer. ADVR's AVR118 is a biopolymer that possesses novel immunomodulator activity. This peptide-nucleic acid complex, which, to date, has demonstrated a very favorable safety profile, appears to stimulate the pro-inflammatory responses required to combat viral infections such as HIV and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. Data presented at the American Society of Clinical Oncology's (ASCO) annual meeting in June, 2004, showed that AVR118 appears to have activity against fatigue, loss of appetite, and weight loss in patients with HIV. For further information regarding Advanced Viral Research Corp., please visit our website at www.adviral.com. ADVR, based in Yonkers, New York, is a biopharmaceutical firm dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for viral and other diseases.

Source: Advanced Viral Research Corp.

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AVR118 FREQUENTLY ASKED QUESTIONS

• What is it?• What does it do?• How does it do this?• Is it a new idea?• Is it patent protected?• Has it been tested in people?• What are the results?• Is it safe?• What is your strategy?• What will this cost?• When will the results of the Israeli studies be available?• What is the competition?• Return on Investment

What is it?Peptide Nucleic AcidAVR118 belongs to a new class of compound – a peptide nucleic acid.back to top

What does it do?ImmunomodulationIt is an immunomodulator which can turn on the immune system to mount a proinflammatory response as is needed to treat viral infections or cancers or in aberrant situations where the immune system is overactive, such as occurs in autoimmune diseases like rheumatoid arthritis, it can switch it off. back to top

How does it do this?Novel Mechanism of ActionIt interacts with receptors on cell surfaces to switch them on or off. In addition it stimulates the production of chemical messengers which can stimulate the immune system. back to top

Is it a new idea?Based on Long Established ConceptsThe idea of stimulating the immune system is not new. In fact a forerunner product – Reticulose, which was a mixture of peptides and nucleic acids was used successfully in the USA until the 1960’s. AVR118 however, is new; it is a well-characterized drug that contains a unique peptide nucleic acid. back to top

Is it patent protected?U.S. Patent ProtectedIt is protected by U.S. Patent No. 6,303,153, seven other issued patents and 20 patent applications. back to top

Has it been tested in people?Human Data AvailableA double-blind placebo controlled clinical trial was conducted at the University Hospital in Barbados. A Phase I clinical trial on the topical treatment of genital warts has been conducted in the United States.back to top

What are the results?Evidence of Safety, EfficacyThe double-blind placebo controlled study in HIV/AIDS patients in Barbados showed increases in well-being, weight and CD4 count in the group treated with AVR118. The Phase I clinical trial for the topical treatment of genital warts has been completed under an FDA IND in the U.S. Overall results of the Phase I clinical trial indicate that AVR118 was safe and well tolerated dermatologically in all the doses applied in the study. back to top

Is it safe?Excellent ToleranceToxicology studies in animals suggest it is apparently non-toxic. Excellent tolerance has been observed in patients. back to top

What is your strategy?A Candidate for PartnershipOur plan is to develop AVR118 to a stage where it will be attractive as a licensing candidate to a large pharmaceutical company. So far we have had an IND for topical application to genital warts approved in the USA and have successfully completed a safety study in volunteers. An initial efficacy study in genital warts is planned.

We have received approval from the State of Israel to begin 3 safety/initial efficacy studies in patients suffering from body wasting (cachexia) and a) solid cancerous tumors, or leukemias/lymphomas, or c) AIDS not adequately responding to antiviral drugs.back to top

What will this cost?$6 Million First Year Development ProgramThe first year costs of the clinical program described above are expected to be approximately $6 million.back to top

When will the results of the Israeli studies be available?Results Expected Within 12 Months of the Start of the StudyWe expect to begin the studies as soon as the funding is produced and anticipate the completed results within 12 months. back to top

What is the competition?More Effective Treatments for Cachexia Are NeededMegace (BMS) and human growth hormone (Serono) are indicated for the treatment of cachexia associated with AIDS. However, many physicians consider that current treatments are inadequate. back to top

Return on InvestmentReturns on Investment Are Dependent Upon the Clinical Efficacy of the Drug.The historical investment patterns of biotechnology companies have been that multifold returns are achieved when companies progress from the development stage to completed Phase II clinical trials. back to top

Please click here to download this information sheet.PDF Format - 16KB

Note: This fact sheet contains forward-looking statements that involve risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by the Company. AVR118 is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. There is no assurance that the Company will be able to secure the financing necessary to continue and/or complete the clinical trials of AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company. The Company undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

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