Taxman - You obviously don't understand the link between HPV and
cervical cancer. A very large percentage of cervical cancer cases result
from the progression of the HPV virus. If one can control the HPV virus
topically, one can mitigate the progression of the HPV virus to cervical
cancer. Therefore in many cases the treatment or prevention of cervical
cancer may be directly linked to the treatment of HPV. Now you may
From today's press release: "Several strains of HPV are associated with the appearance of cervical cancer which is one of the most common malignancies infecting women. Some 500,000 cases of invasive cervical cancer are diagnosed worldwide each year."
ADVR Begins Phase 2 of IND for Topical Treatment of Genital Warts with Product R
Yonkers, N.Y., April 12, 2002: Advanced Viral Research Corp. (OTCBB: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 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.
Mayr Communications, Inc.
mind- This "old news" contains another point that I meant to make
earlier relative to "today's" patent protection.....
"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."
So, even according to the company....today's "new" news, is actually yesterday's "old news".....