Advanced Viral Research Files an Amendment to its Existing IND to Include Topical and Intralesional Therapy
Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) a bio-pharmaceutical company, announced today that it has filed an amendment with the FDA to its existing IND to expand the use of its product, AVR118 to include topical and intralesional therapy. These applications could potentially be used to treat a wide variety of common dermatologic conditions that are extremely problematic to treat.
"Having successfully completed a preliminary wound healing study at the University of Miami, as well as completing a phase I study confirming safety, we are ready to begin a phase II pilot study in patients with common skin problems. Based on recent discussions with clinical investigators, we are anxious to finalize our plans for studying how AVR118's ability to promote tissue repair and regeneration can be put to use in the clinical setting," says Stephen Elliston, CEO of Advanced Viral.
"The current plan is to treat skin lesions ranging from surgical wounds to acne scars. If efficacy can be established as a topical or intralesional therapy, the commercial prospects for our product will increase dramatically. We have begun work in developing a topical formulation that can easily be applied directly onto the skin.
The multi-billion dollar wound healing industry is in great need of products that can not only facilitate the healing of wounds, but also minimize the cosmetic impact of scarring. Dermatologists we have been in discussions with are extremely comfortable in the safety profile and are anxious to explore its efficacy in a wide variety of skin lesions," 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 adviral.com.
SOURCE: Advanced Viral Research Corp. |
