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Advanced Viral Begins Phase II Dermatological Study |
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30 Jan 2007 |
Announced today that the Company has begun a Phase II study using a topically applied spray formulation of AVR 118 as a wound healing agent.
YONKERS, NY, USA | Jan 29, 2007 | Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) a bio-pharmaceutical company, announced today that the Company has begun a Phase II study using a topically applied spray formulation of AVR 118 as a wound healing agent. Based upon the preliminary results previously seen in an animal model at the University of Miami, this study is designed to determine if a similar response can be demonstrated in humans. The study population will be divided into two cohorts of patients who will undergo a one week course of therapy.
The first cohort of patients will have undergone plastic surgery and must present a minimum of two bilateral surgical wounds. AVR118 will be applied to one wound so that the second wound will serve as an untreated control. The objective is to determine if AVR 118 can accelerate the time taken for the wound to close. A secondary objective will determine if AVR 118 can reduce or eliminate subsequent scar formation.
The second cohort of patients will have undergone an exfoliative dermatologic procedure for eliminating acne induced scaring known as derm-abrasion. Following the derm-abrasion therapy, AVR 118 will be applied directly to one half of the inflamed facial tissue using the topically applied AVR 118 spray. The other half of the face will serve as an untreated control. The objective is to determine if AVR 118 can effectively reduce inflammation and accelerate the rate of tissue regeneration.
“If we can document definitive activity in this study, we will aggressively pursue an expanded clinical program to include a wide range of indications where AVR 118 can be administered alone or in combination with other drugs to facilitate wound healing,” says Stephen M. Elliston, CEO of Advanced Viral Research. “In addition, we may also explore a multitude of new formulations such as creams, lotions and impregnated bandages that can be applied to various types of skin lesions. Although we have had numerous anecdotal reports claiming efficacy in various topical applications, it has never been formally tested in a Phase II trial,” added Elliston.
Advanced Viral Research Corp is a New York based biopharmaceutical company dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for the systematic control of symptoms associated with cancer and other serious diseases. ADVR's lead product, AVR118 represents a new class of complex cytoprotective agents that target among other things, cachexia related disorders. AVR118 has also shown to have topical wound healing properties in animal models. Various degenerative conditions associated with body wasting (cachexia) such as cancer, HIV/AIDS and chronic inflammation are potential disease targets for AVR118 therapy.
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. AVR118 (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 AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company or that if completed, clinical trials performed outside the United States 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.
For further information regarding Advanced Viral Research Corp., please Visit our website at http://www.adviral.com.
SOURCE: Advanced Viral Research Corp. |
