Advanced Viral Research (BB: ADVR)
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By: thatsamore3
05 Apr 2004, 11:58 AM EDT
Msg. 146104 of 146259
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HIV Finds New Way To Play Hide And Seek

4/5/2004

Source: Rockefeller University Press

The deadly virus HIV can mutate to prevent display of its components to immune cells, thus concealing itself from the body's surveillance system and resulting in faster progression to AIDS, report Philip Goulder and colleagues in The Journal of Experimental Medicine. This has important implications for design of the long-sought-after vaccine for HIV.

When someone is infected with HIV, certain regions of viral proteins are chopped up and displayed by infected cells to their immune system, using platforms known as MHC molecules. These protein fragments are recognized by killer cells, which destroy the virus-infected cells. Viruses have evolved many clever mechanisms to avoid being detected in this way, including altering the protein fragments that our immune system recognizes. This study identifies for the first time, in the course of a natural human infection, HIV mutations outside of the regions that are recognized that actually prevent generation of the protein fragments. HIV can, apparently, alter its sequence so that the human chopping proteins can no longer grab onto the viral protein.

Cells infected with this mutant virus are not detected by the immune system, so the virus can replicate and increase in number. This was initially surprising, because the changes in the virus are in regions that are considered to be invisible to the immune system. But the new work indicates that vaccine designers must pay attention not only to the regions of HIV that are recognized by the immune system, but also to the nearby regions that allow the chopping proteins to do their work.

LETTER FROM THE CEO

April 2004


To our Valued Shareholders:

As the new CEO of Advanced Viral Research Corp., I am delighted to be on board and am excited about the future. Although we have recently filed our 10K with the SEC, I wanted to reach out to you - our shareholders - in a more personal way. Our shareholders are the backbone of our Company and we thank you for your support.

As part of a new, open communications plan, I wanted to share some of our future plans and upcoming events with you.

STRATEGY

Since starting in mid-February, I have been focused on major business initiatives and strategic direction. We remain dedicated to our mission of introducing AVR118 to patients and are taking all of the necessary steps to make this possible. It is my experience that a solid strategic direction is critical to the success of any company. To this end, I am developing a cogent and focused strategy with very clear objectives. It is my personal commitment, as well as that of the Company, to deliver on those objectives in a timely fashion.

As you know, drug development is a long and costly endeavor that is done under the auspices of the Food and Drug Administration (FDA) in the United States. I have spent the last two decades in drug development and know first-hand what it takes to get a product approved by the FDA for marketing. The only way forward for Advanced Viral is to remain focused on conducting high-quality clinical trials on AVR118 in the United States in accordance with FDA regulations. It is tantamount that we lay a solid foundation in working with the FDA and conduct clinical trials in accordance with Good Clinical Practices. We will also be paying a great deal of attention to other, relevant operations which are equally important in drug development such as quality control, quality assurance, and manufacturing.

It is our hope that the clinical trials in Israel will help facilitate the trials in the United States; however, it is important to point out that any clinical trial is unpredictable and there can be no assurances as to start date, enrollment rate and completion date. While data cannot be disclosed on an ongoing basis due to the need for data verification and database validation, we are encouraged by the early findings in our Israeli trials and anticipate completion by the end of the second quarter this year.

COMMUNICATION

We recognize that regular, clear and accurate communication is essential. We have some exciting upcoming events, which include:

  • Presentation at ASCO: We will be presenting a poster at The American Society of Clinical Oncology's (ASCO) 40th Annual Meeting in June of this year. ASCO is the world's leading professional organization representing physicians who treat people with cancer and we are thrilled to be invited to such a prestigious conference. As you probably are aware, any information regarding the presentation is under embargo by ASCO until the day of the presentation.

  • Presentation at an Equities Conference: We will be presenting at the Symposium's Small Cap Equities Conference on June 2nd at the Roosevelt Hotel in New York City.

  • «Meet the CEO» Sessions: I anticipate setting up a road show to meet with investors personally in May in Boston, New York and Florida should there be sufficient interest from our shareholders. Please e-mail Veronica Welch at ronnie@cwrpartners.com if you are interested in attending. I look forward to meeting with as many investors as possible.

  • Open-house: We will host an open-house event at our corporate headquarters in Yonkers, NY in July. Please contact Maria Marino at mariag@adviral.com for a reservation.

  • Quarterly updates: We will be giving quarterly updates either by conference call or by letters such as this one.

  • E-Communication: We are revamping our web site to make it more user-friendly and informative. We will also introduce an e-mail system whereby investors can automatically receive press releases and updates via e-mail. An overhaul will also be done for our investor relations and media kits.

  • Media: We continue to speak with the national media on a daily basis regarding the benefits of AVR118. This campaign will be stepped up during the second half of the year.

On a final note, the values with which I will drive the Company are integrity and honesty. I appreciate your continued support of our company and, most of all, thank the employees for their dedication and tenacity. You can rest assured that we are working aggressively to meet all of our strategic objectives. Please continue to refer to our web site for investor updates and press releases.


Sincerely,

Elma S. Hawkins, PhD, MBA
President and Chief Executive Officer


Note: The information contained herein 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 complete the clinical trials of AVR118. 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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