ADVR Granted U.S. Patent for Treatment of Human Papillomavirus
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8 January 2004, 07:31am ET
YONKERS, N.Y., Jan. 8 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp. (BB:ADVR) today announced that it has been awarded U.S. Patent Number 6.670,118 entitled "Method for Treating Papillomavirus Infections". The patent describes the use of AVR118 (previously known as Product R) for the topical treatment of patients suffering with lesions resulting from human papillomavirus (HPV) infections, including genital warts.
ADVR has completed a Phase I clinical trial in the U.S. to evaluate the safety of topical application of AVR118 in healthy volunteers. There were no local adverse reactions to the application of AVR118 to the skin of these subjects. The Company is now planning Phase II trials for the topical use of AVR118.
HPV is a common world-wide sexually transmitted infection (STI). The American Social Health Association estimates there are approximately 5.5 million new cases of sexually transmitted HPV infections reported each year and at least 20 million Americans are infected.
The most common clinical manifestation of HPV is warts which are benign tumors. The most common infections caused by strains of HPV are digital and plantar warts -- warts on the hands and feet, commonly seen in children. These warts represent one of the most prevalent dermatologic infections worldwide. 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. In developing nations, cervical cancer is the most common female malignancy, accounting for 24% of all cancers in women. In developed countries, cervical cancer ranks behind cancer of the breast, lung, uterus and ovaries, accounting for some 7% of all cancers in women.
Patients suffering with immunodeficiencies, such as patients with AIDS, are particularly susceptible to infection with HPV. Disseminated HPV in.fection is one of the opportunistic infections complicating AIDS and is manifested by eruption of generalized, often very painful warts over the body. At present, there is no specific and satisfactory therapy for disseminated HPV infection in AIDS patients.
Mentioned Last Change
ADVR 0.126 (Unchanged)
"Use of AVR118 in the treatment of HPV infection is a potentially significant contribution of AVR118 to the therapy of a prevalent and troublesome viral infection that is responsible for much morbidity over the world. The potential of AVR118 as a therapy for disseminated HPV infection in patients with AIDS merits further clinical study," said James T. D'Olimpio M.D., a clinical consultant to ADVR.
ADVR's AVR118 represents a biopolymer chemistry that possesses novel immunomodulator activity. This peptide-nucleic acid, which to date has shown no indication of human toxicity, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. AVR118 is in clinical trials in Israel for the treatment of cachexia (body wasting) in patients with AIDS.
For further information regarding Advanced Viral Research Corp., please visit our website at www.adviral.com . 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.
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.
Contact: Ronnie Welch or
CWR & Partners
SOURCE Advanced Viral Research Corp.
/CONTACT: Ronnie Welch, or Kelly Cinelli, +1-508-222-4802, both of CWR &
Partners, for Advanced Viral Research Corp./
/Company News On-Call:
CO: Advanced Viral Research Corp.
ST: New York
IN: HEA MTC BIO OTC
-- NYTH030 --
3061 01/08/2004 07:31 EST
"ADVR has completed a Phase I clinical trial in the U.S. to evaluate the
safety of topical application of AVR118 in healthy volunteers. There
were no local adverse reactions to the application of AVR118 to the skin
of these subjects. The Company is now planning Phase II trials for
the topical use of AVR118."
Human Papilloma Virus
(Genital Warts, Cervical Dysplasia & Cancer, A.n.a.l Dysplasia & Cancer)
What is it?
Human papilloma virus (HPV) is spread via sexual activity. Nearly 40 million people in the United States are infected with HPV.
HPV can cause three different types of diseases, mostly in or around the genital area:
Warts: HPV can cause warts – small, raised, hard lumps that grow in clumps – to form in or around the vagina, a.n.u.s, or the tip of the p.e.n.i.s. Genital warts are sometimes called condylomata acuminata, or condylomas. Left untreated, genital warts can develop into cancer.
Dysplasia: Abnormal cells found inside the a.n.u.s or within the cervix (located at the lower end of the uterus, or womb). Dysplasia is often referred to as a "pre-cancer" form of disease. Not all men or women with dysplasia go on to develop cancer.
Cancer (carcinoma): Both warts and dysplasia can develop into cancer. The four most common types of cancer caused by HPV are cervical cancer, a.n.a.l cancer, rectal cancer, and p.e.n.i.l.e cancer. If not diagnosed and treated early, these forms of cancer can be life-threatening.
HIV-positive people are more likely to be infected with HPV than HIV-negative people. HIV+ people are also more likely to develop genital warts, as well as cervical or a.n.a.l cancer, as a result of HPV. Researchers don't yet know if anti-HIV drugs will help reduce the number of new cases of genital warts or a.n.a.l or cervical cancers. In fact, some researchers speculate that, because anti-HIV drugs have been successful in keeping HIV-positive people alive longer, the risk of developing genital warts or cancer might increase.