Advanced Viral Announces Phase IIb Wound Healing Trial For AVR123

Main Category: Dermatology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 29 Oct 2008 - 0:00 PDT

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Advanced Viral Research Corp. (OTC Bulletin Board: ADVR), announced that it has commenced a Phase IIb efficacy study for AVR123 in wound healing.

The Phase IIb trial is being conducted at the Friedrich Alexander University Hospital in Erlangen Germany, led by Eckhart Kampgen, M.D., Associate Professor for Strategies of Cellular Immunotherapy at the Department of Dermatology. Dr. Kampgen is leading the Immunomonitoring, RNA and Melanoma Division at the hospital. He has over 80 peer-reviewed publications and has participated as Principal Investigator or Sub-Investigator in more than 20 Phase I, II and III clinical studies since 1995.

The primary objective of this study is to evaluate the effect of AVR123, applied topically, on the rate and quality of healing of wounds. According to the protocol, patients enrolled in the study will include individuals with a variety of wounds and dermatologic conditions.

AVR123 is a topical formulation of ARV118 which is currently being investigated for the systemic treatment of cancer related clinical cachexia. This compound has well-documented anti-inflammatory and wound healing activities. Results of a Phase I, open label, dose-escalating study indicated that topical AVR123 is well-tolerated, showing no dose-limiting toxicities. Initial observations of accelerated wound healing in a pig study at the University of Miami suggest that AVR123 may represent an important advance in the management of wounds.

Stephen Elliston, President and Chief Executive Officer of Advanced Viral, stated, "This trial has been designed to provide further evidence to substantiate encouraging preliminary results seen in the initial phase of the study, which was not completed due to the death of the study's Principal Investigator. We are highly fortunate to have Dr. Kampgen, a prestigious leader in the dermatological field, to oversee this trial. His experience in this area will be invaluable for gaining greater insights into AVR123's potential efficacy."

"We are highly excited with the prospects for introducing AVR123 into Europe," added Mr. Elliston. "This is the first time that ADVR has conducted a trial in Europe, which now represents a market almost as large as the U.S."

Dr. Kampgen said, "Very few drugs, other than antibiotics, are approved for wound healing and we are delighted to be working with AVR123. Initial studies will involve patients with lesions similar to wounds treated in the University of Miami pig study. Based on positive results from this study, it is conceivable that AVR123 may play an even more important role in the treatment of more serious patient populations, such as those with chronic ulcers."

The global wound care market is estimated to be over $7 billion annually. It is comprised of a wide variety of prescription and over the counter products that include antibiotics, antiseptics and dressings. The US$4.1 billion global advanced wound care segment is the fastest growing area with double-digit growth of 10% per year.

In tandem with the commencement of this trial, ADVR has received the third installment of financing from Yorkville Capital partners in the amount of $249,500.

About Advanced Viral Research Corp.

Advanced Viral Research Corp. is a biopharmaceutical company dedicated to the discovery and development of small molecule anti-cancer drugs. Its initial compounds, AVR118 and AVR123, represent a new class of cytoprotective agent that targets, among other things, some of the most problematic symptoms associated with clinical cachexia or the so called wasting syndrome. In addition, AVR118 and AVR123 have also been shown to possess topical wound healing properties in animal models. Various degenerative conditions associated with cachexia such as cancer, HIV-AIDS and chronic inflammation are potential disease targets for AVR118 and AVR123 therapies. For further information regarding Advanced Viral Research Corp., please visit the website at http://www.adviral.com.

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. AVR118 and AVR123 are 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 operations and/or complete the clinical trials of AVR118 or AVR123, or satisfy certain other conditions relating to clinical trials or that if the trials are completed, this will assist the Company in obtaining FDA or other regulatory approval. 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.

Advanced Viral Research Corp.
http://www.adviral.com