ADVR Granted Therapeutic Composition Patent For Product R

U.S. Patent Awarded for Chemical Structure of Novel Peptide Nucleic Acid

27-Mar-2003

Advanced Viral Research Corp. announced that it has been awarded an U.S. Patent, entitled "Preparation of a Therapeutic Composition," for Product R, the peptide nucleic acid immunomodulator currently in clinical trials in Israel.

The claims of the newly issued patent focus on the chemical structures of the two unique peptides that constitute Product R. The patent describes the amino acid compositions and sequences of peptides A and B. In addition, the claims include the nature of the polynucleotide conjugate of peptide B. Product R is composed of two peptides that, in combination, produce a stable biopolymeric structure highly resistant to degradative enzymes such as nucleases and peptidases.

"This new patent is a significant and important addition to the intellectual property of Advanced Viral Research Corp. The chemical structure of the peptide nucleic acid described in this patent unfolds a rich, new chemistry that may yield important future therapeutic agents related to Product R," said Shalom Z. Hirschman, M.D. President and CEO. "The patent describes the unique chemical structure of the two peptides present in Product R, including the peptide that is a novel peptide nucleic acid conjugate. The chemical structures of the peptides of Product R were filed in our Drug Master File submitted with our investigational new drug (IND) application to the US FDA in 2001."

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"We believe that Product R may one day play a broad role in the treatment of a variety of diseases," said Eli Wilner, Chairman of the Board of Advanced Viral. "We are committed to ensuring that the intellectual property associated with the ultimate commercialization of Product R is broadly and adequately protected."

In October 2001 the company was granted a U.S. Patent for the preparation and overall composition of Product R. ADVR holds 10 U.S. patents related to Product R that cover such areas as the preparation and chemistry of Product R, and such uses as the treatment of anemia by stimulating red blood cell production, the treatment of canine distemper, the treatment of human parvovirus infection, the treatment of basal cell carcinoma, and the topical treatment of skin and eye infections.

Israeli Clinical Trials

Advanced Viral Research Corp. is currently conducting three Israeli clinical trials for Product R including:

* a Phase I/II clinical trial with injectable Product R in cachectic patients who have failed highly active antiretroviral therapy and require salvage therapy; * a Phase I clinical study for the treatment of body wasting (cachexia) in patients with solid tumors; and * a Phase I clinical trial for cachectic patients with hematopoietic and lymphoid tumors, including acute lymphocytic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma.

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