AEGiS-PRn: ADVR Begins Product R Israeli Clinical Trials; Quintiles Retained to Monitor/Audit Trials, Selikoff Center to Conduct Trials PRNewswireImportant note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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ADVR Begins Product R Israeli Clinical Trials; Quintiles Retained to Monitor/Audit Trials, Selikoff Center to Conduct Trials

PRNewswire - November 14, 2002


YONKERS, N.Y., Nov. 14 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) today announced that it has initiated the single dose safety study which is the first phase of three Product R clinical trials in Israel. The Company also announced that it has retained Quintiles Transnational Corp.'s (Nasdaq: QTRN) Israeli unit to independently monitor and audit the clinical trials according to U.S. Food and Drug Administration (FDA) standards. ADVR has entered into an agreement with EnviroGene, LLC, an affiliate of the Selikoff Center for Environmental Health and Human Development in Israel, to conduct the clinical trials. The lots of Product R for use in the clinical trials were produced following U.S. FDA cGMP regulations in ADVR's plant in Yonkers, N.Y.

"These clinical trials are designed with the ultimate objective of moving Product R into clinical use as quickly as possible," said Shalom Z. Hirschman, M.D., President and CEO of Advanced Viral Research Corp. "We plan to build on these clinical trials so as to increase the potential clinical applications of Product R as an innovative and safe therapeutic agent."

"We are very pleased to have retained the Israeli unit of Quintiles, a leading contract research organization, to monitor and audit the clinical trials. ADVR now is focusing its scientific staff and fiscal resources on moving Product R through the proper clinical trials needed to ultimately bring Product R into the pharmaceutical marketplace," Dr. Hirschman added.

"I am gratified that the clinical trials in Israel are under way. We look forward to these trials assessing the effects of Product R as a new drug candidate for the U.S. FDA and worldwide regulatory agencies," said Eli Wilner, Chairman of the Board. "With the recently announced staff reductions, and our announced intent to sell our Freeport, Bahamas, facility, we have taken steps to streamline the Company and focus our resources on the objective of undertaking these important trials. We are committed to developing Product R as efficiently as possible for the treatment of diseases that represent potentially significant market opportunities."

Overview of Israeli Clinical Studies

Phase I/II Study In Cachectic Patients Needing Salvage Therapy For AIDS The Phase I segment of these clinical trials is a dose escalation study designed to determine the safety and toxicity profile of Product R. The study also will determine the effect of Product R on AIDS related wasting (cachexia). The possible salvage effects of Product R in these patients will be investigated as well. The study population will be composed of patients aged 18 years or older who have received maintenance anti-retroviral therapy for at least one month prior to entry into the study. The patients will have experienced involuntary weight loss of greater than 10% of pre-morbid body weight during the prior six months.

The clinical study protocol was designed by medical researchers at the Selikoff Center for Environmental Health and Human Development in collaboration with the principal investigator, Professor Zev Shtoeger, and staff members of the Company's FDA consultants, Globomax, LLC. The clinical trial will be based at The Kaplan Medical Center that serves as a clinical facility for the School of Medicine of The Hebrew University.

The Centers for Disease Control and Prevention (CDC) estimate a prevalence of 850,000 to 950,000 patients in the U.S. with HIV infection. The CDC further estimate that approximately 40,000 persons are newly infected with HIV each year in the U.S. and that there were 15,245 AIDS related deaths in the U.S. in 2000. The National Institutes of Health (NIH) estimates that 40 million people worldwide were living with HIV/AIDS at the end of 2001. The CDC estimate that at least 20% of patients do not respond to HAART or cannot tolerate the drugs that make up HAART regimens.

Phase I Study In Cachectic Patients with Solid Tumors

In this Phase I trial, objectives include observations on the effects of Product R in treating and mitigating cachexia and possible responses in treating the tumor itself. The trial will be conducted as a Phase I dose escalation study preceded by a pre-Phase I single injection study. The clinical trial will be conducted in patients aged 18 years or older with advanced stage malignancies not amenable to curative or life prolonging therapy, manifesting body wasting (cachexia) as defined by a greater than 10% involuntary weight loss over the prior six months.

The principal sites for this study are the Chaim Sheba Medical Center in Tel Hashomer, Israel, and the Rabin Medical Center (Beilinson Campus) in Petach Tikvah, Israel. The protocol for this trial was designed by medical researchers at the Selikoff Center in collaboration with the principal investigator, Dr. Rony Weitzen, Acting Head of Day Care Unit, Institute of Oncology, the Chaim Sheba Medical Center, and staff members of Globomax, LLC.

The American Cancer Society estimates that female breast, colorectal, lung and bronchus, prostate and urinary bladder cancers will account for a total of 766,700 new cases of solid tumors and 281,300 deaths in the U.S. in the year 2002.

Phase I Study in Cachectic Leukemia and Lymphoma Patients

The objective of the trial is to determine the safety and toxicity profile of Product R in a population of patients with advanced stage hematopoietic and lymphoid malignancies not amenable to curative or life prolonging therapy who manifest cachexia (body wasting). The study will emphasize the population of patients with acute lymphocytic leukemia, Hodgkin's or non-Hodgkin's lymphoma.

The principal investigator for the trial is Professor Dina Ben Yehuda, the Chairperson of Hematology at the world renowned Hadassah Medical Center of The Hebrew University, in collaboration with Professor Arnon Nagler, the Chairperson of the Hemotology Institute of the Chaim Sheba Medical Center at Tel Hashomer, Israel. The protocol for the trial was designed by medical researchers at the Selikoff Center in collaboration with Professor Dina Ben Yehuda and staff members of Globomax, LLC.

The American Cancer Society estimates that 60,900 new cases of lymphoma will occur in the U.S. in the year 2002, comprising 7,000 cases of Hodgkin's disease and 53,900 cases of non-Hodgkin's lymphoma. These cancers are estimated to cause a total of 25,800 deaths in the U.S. in the year 2002. It is estimated that 30,800 new cases of leukemia will occur in the U.S. in 2002 and that 21,700 patients will die with leukemia in 2002.

Product R

ADVR's Product R represents a biopolymer chemistry that possesses novel immunomodulator activity. This peptide-nucleic acid, which to date has shown no indication of human toxicity, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papilloma virus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. Therefore, Product R has been termed a "switch-type" immunomodulator.

Advanced Viral Research Corp., 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.

For further information regarding Advanced Viral Research Corp., please visit our website at http://www.adviral.com.

Note: This news release 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. Product R 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 Product R 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.

MAYR COMMUNICATIONS INC - CONTACT: CHARLES MAYR

TEL: 877.777.6010 - MAYRCOMM@ATT.NET

SOURCE Advanced Viral Research Corp.

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


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