YONKERS, N.Y., April 12 /PRNewswire-FirstCall/ -- Advanced Viral Research
Corp. (OTC Bulletin Board: ADVR) today announced the start of Phase 2 of its
Investigational New Drug (IND) application to the U.S. Food & Drug
Administration (FDA) for the topical treatment of genital warts with Product
R.
The Company has submitted to the FDA the results of the Phase 1 clinical
trial under this IND and no adverse comments concerning the Phase 1 results
have been received from the FDA. The Company now is beginning Phase 2
clinical trials by recruiting clinical sites to perform these studies in
patients with genital warts in the United States.
Results of the Phase 1 clinical trial indicate that Product R was safe and
well tolerated dermatologically in all the doses applied in the study. During
the course of Phase 2, the efficacy of Product R for the topical therapy of
genital warts will be investigated in various doses.
The incidence of genital warts caused by infection with strains of the
human papilloma virus (HPV) continues to rise in the United States, especially
amongst sexually active young men and women. The Centers for Disease Control
and Prevention (CDC) estimate that 20 million persons in the United States
have genital HPV infection. Advanced Viral Research Corp. believes that there
is a need for more effective and better tolerated therapeutic options.
Certain subtypes of the human papilloma virus, such as subtypes 16 and
18, are associated with the development of cervical cancer in women. Cervical
cancer is one of the most prevalent cancers in women worldwide. Based on
animal studies, Product R appears to have the advantage of not causing any
local toxic effects when applied to mucous membranes such as the vagina and
cervix, which may allow Product R to be used for topical therapy
intravaginally to treat infection with HPV.
The Company was awarded U.S. Patent No. 6,355,226 entitled "Topical
Treatment of Skin Disease and Eye Afflictions" issued on March 12, 2002, which
protects the use of Product R, for topical treatment of skin infections such
as genital warts caused by HPV infection.
"We were extremely gratified by the data obtained during the Phase 1 trial
for the topical treatment of genital warts with Product R," stated Shalom Z.
Hirschman, MD, CEO & President of Advanced Viral Research Corp. "The Company
is now beginning Phase 2 of this IND process. It is our objective to bring
Product R into the pharmaceutical marketplace as quickly and as efficiently as
possible."
Product R is being investigated as a non-toxic peptide-nucleic acid-type
immunomodulator that appears to stimulate the proinflammatory responses
required to combat viral infections such as AIDS and human papilloma virus and
to dampen aberrant autoimmune-type inflammatory responses, such as occur in
patients with rheumatoid arthritis. Therefore, Product R has been termed a
"switch type" immunomodulator. Product R is also being studied for the
promise shown in its ability to mitigate the toxic side effects of other
drugs, including those used to treat HIV infection and chemotherapeutic drugs
employed in the treatment of cancers.
Advanced Viral Research Corp., based in Yonkers, New York, is a
biopharmaceutical firm dedicated to improving patients' lives by researching,
developing and bringing to market new and effective therapies for viral and
other diseases.
For further information regarding Advanced Viral Research Corp., please
visit our website at http://www.adviral.com.
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. 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 Product R or satisfy certain other conditions relating to clinical
trials including obtaining adequate insurance on terms acceptable to the
Company. 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.
Contact Information:
Mayr Communications, Inc.
877-777-6010
mayrcomm@att.net
SOURCE Advanced Viral Research Corp.
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Related links:
http://www.adviral.com
CONTACT:
Mayr Communications, Inc., +1-877-777-6010,
mayrcomm@att.net, for Advanced Viral Research Corp.
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