Virus-Free, Inc.
1565 Genome Way
San Diego, CA 92128
March 29, 2009
Central Document Room
Center for Drug Evaluation and Research
Food and Drug Administration
5901-B Ammendale Road
Beltsville, Maryland 2070501266
Re:
AV-5656 Tablets
Initial Investigational New Drug Application
IND 109,876, Serial Number 0000
Dear Sir or Madam:
Virus-Free, Inc. is submitting three copies of an initial Investigational New Drug
Application (IND) for AV-5656. The chemical name of the active ingredient is 1,5,7,2tetramethyl, 3-amino, 6-bromo-viruskill. AV-5656 is intended to be studied as a virallysis tablet to treat blood-borne viral infections.
At this time, Virus-Free is submitting a protocol to begin a Phase 1, single and multiple
dose trial in healthy male and female subjects. This study will be conducted at Florida
General Hospital by Betty Sue Lee, M.D.
Virus-Free has previously discussed this proposed development plan during a pre-IND
meeting with the Division of Antiviral Products on January 5, 2009 and our Phase 1
clinical protocol has been modified as discussed at that meeting. A copy of the minutes
from that meeting is included in this submission.
Virus-Free commits to conduct this clinical investigation in accordance with all
applicable regulatory requirements.
Virus-Free will not initiate this clinical study until this IND has become effective and
Investigational Review Board (IRB) approval has been received.
Virus-Free, Inc.
Page two
Virus-Free considers the material and data contained in this application to be confidential
and not to be publically disclosed.
If you have any questions regarding the submitted information, please do not hesitate to
contact me by telephone at 858-455-5565 or by email at jstudent@virus-free.com.
Sincerely,
Joe Student
Senior Director, Regulatory Affairs
Virus-Free, Inc.