Message #1 From:
NewsBot Date: November 11, 2004 10:09:17 PM
ADVR Full Description Message Board
ADVR Advanced Viral Research Corp., incorporated in July 1985, is
primarily engaged in the production and marketing, promotion and sale
of a pharmaceutical drug known by the trademark Reticulose. The
current formulation of Reticulose is known as Product R. Product R
may be employed in the treatment of certain viral and autoimmune
diseases such as human immunodeficiency virus (HIV), including
acquired immune deficiency syndrome (AIDS); human papilloma virus
(HPV), which causes genital warts and may lead to cervical cancer;
cachexia (body wasting) in patients with solid cancers, leukemias and
lymphomas, and rheumatoid arthritis.
Since 1962, when Reticulose was reclassified as a new drug by the
United States Food and Drug Administration (FDA), the FDA has not
permitted Reticulose to be marketed in the United States. A
forfeiture action was instituted in 1962 by the FDA against
Reticulose, and it was withdrawn from the United States market. The
injunction obtained by the FDA prohibits, among other things, any
shipment of Product R until a new drug application (NDA) is approved
by the FDA. FDA approval of an NDA first requires clinical testing of
Product R in human trials, which cannot be conducted until the
Company first satisfy the regulatory protocols and the substantial
pre-approval requirements imposed by the FDA upon the introduction of
any new or unapproved drug product pursuant to an investigational new
drug application (IND).
The Company's operations have been limited principally to research,
testing and analysis of Product R in the United States, either in-
vitro (outside the living body in an artificial environment, such as
in a test tube), or on animals, and engaging others to perform
testing and analysis of Product R on human patients both inside and
outside the United States. On July 30, 2001, the Company submitted an
IND application to the FDA to begin Phase I clinical trials of
Product R as a topical treatment for genital warts caused by the
human papilloma virus (HPV) infection. In September 2001, the FDA
cleared the IND application to begin Phase I clinical trials. The
Company's Phase I study was performed in the United States on human
volunteers. In March 2002, the Company completed the Phase I trial
and submitted to the FDA the results, which indicated that Product R
was safe and well tolerated dermatologically in all the doses applied
in the study. Advanced Viral Research does not have sufficient funds
available to pursue the Phase II clinical trials of Product R as a
topical treatment for genital warts caused by HPV infection.
In June 2002, the Israeli Ministry of Health approved the testing of
Product R in the following clinical trials using injectable Product
R, which began during November 2002: Phase I/Phase II study in
cachectic patients needing salvage therapy for AIDS; Phase I study in
cachectic patients with leukemia and lymphoma, and Phase I study in
cachectic patients with solid tumors. The Company's objective for the
three Israeli trials is to determine the safety, tolerance and
metabolic characteristics of Product R. The Company anticipates that
the clinical trials in Israel will help facilitate the planned IND
application process for injectable Product R with the FDA.
Among the companies with significant commercial presence in the AIDS
market are Glaxo SmithKline, Bristol-Myers Squibb, Hoffmann-La Roche,
Agouron Pharmaceuticals, Merck & Co. and DuPont Pharma. Several
products are marketed for the treatment of cachexia (body wasting),
including Megace oral suspension manufactured by Bristol-Myers Squibb
and Serostim (injectable human growth hormone) marketed by Serono
Laboratories Inc. In the area of HPV treatment, the Company competes
with 3M Pharmaceuticals. and Schering Plough Corp. In the area of
rheumatoid arthritis, the Company competes with Immunex Corp.
REUTERS ABRIDGED FINANCIAL SUMMARY
For the nine months ended 9/30/03, the Company reported no revenues.
Net loss from continuing operations fell 23% to $5.3M. Results
reflect lower research and development expenses and compensation
costs.
Eli Wilner, 47
Chairman
Elma Hawkins, Ph.D.,
Pres, CEO, Director
Martin Bookman,
Acting CFO
Advanced Viral Research Corp
200 Corporate Boulevard South
Yonkers, NY 10701
Phone: (914) 376-7383
Fax: (914) 376-7638
Email: http://www.adviral.com/advr/contact.htm
Web Site: http://www.adviral.com/
Looking for Intelligent Investors to chat with?
Company specific investor chat groups with news, updates, charts
http://www.EquityGroups.com
