New Discovery May Offer Cure for Human Papillomavirus (HPV)

MONMOUTH JUNCTION, N.J., Nov. 29, 2010 /PRNewswire-FirstCall/ --Tamir Biotechnology, Inc. (Pink Sheets: ACEL) (formerly Alfacell Corporation) announced today that scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID) reported test results confirming two of our lead compounds showed excellent in vitro antiviral activity and no cellular toxicity at dose levels tested for Human Papillomavirus (HPV). Testing was performed using the HPV 11 strain, which along with HPV type 6, is responsible for ninety percent of genital or anal warts.

According to the scientist performing the test, the results were among the top one to two percent seen by the researcher for testing of HPV type 11. The report states the following: "Excellent antiviral activity and no cellular toxicity at doses tested."

Within the last several months, we have reported significant results for our compounds against Dengue Fever, Yellow Fever, SARS, CMV, and now HPV. We are on the cusp of building an impressive antiviral portfolio that will be targeting viruses where there is currently an unmet need.  Besides the fact that our drugs have shown significant antiviral activity against the viruses mentioned above, equally impressive is the fact that very low concentrations of our drugs were needed in order to show this significant antiviral activity.

It is important to realize that Onconase®, our lead compound, has been in clinical studies for other oncology indications and has proven itself to be well tolerated in over 1,000 patients treated to date.  We cannot stress enough how significant our drug safety profile is as we look into entering into human clinical trials for those viruses where we have reported significant antiviral activity without the toxicity levels inherent with other viral therapies.

"This latest HPV result confirms and validates the broad range of antiviral activity our compounds have demonstrated in both RNA and DNA viruses. It is quite unusual to find a group of compounds targeting a broad range of viruses from different viral families. These are very exciting times for our shareholders, primary care physicians, and for those patients suffering from these diseases who, for so long, have been waiting for drugs that are safe and effective," stated Tamir Chief Executive Officer Charles Muniz.

About Human Papillomavirus (HPV)

Human Papillomavirus (HPV) is the name for a group of viruses that includes more than 100 types. More than forty types of HPV can be passed through sexual contact. HPV is the most common sexually transmitted disease (STD) in the United States and the world.

When referring to HPV, there are four types of the virus one should know about. This is because these four types cause the most cases of HPV-related diseases in males and females. HPV type 6 and 11 cause about 90% of genital wart cases in males and females. HPV types 16 and 18 cause about 75% of cervical cancers, 70% vaginal cancers, and up to 50% vulvar cancers in females. HPV is thought to be the only cause of cervical cancer, as well as vaginal infections with discharge and chronic infections of the urinary tract.

HPV affects both males and females. HPV transmission can happen with any kind of genital contact with someone who has HPV. Intercourse isn't necessary in order to contract HPV. According to the Centers for Disease Control (CDC), approximately twenty million Americans are currently infected with HPV and an additional six million are infected every year. HPV has become so common that at least fifty percent of sexually active men and women will be infected with HPV at some point in their lives. Half of those infected with HPV are between fifteen and twenty-four years of age.

How Is HPV Spread

HPV is spread through direct sexual contact or, more rarely, skin-to-skin contact during sexual acts. Genital warts, the most obvious sign of HPV infection, are highly contagious. About two-thirds of people who have sexual contact with a partner with genital warts will develop warts, usually within three months of contact.

Signs and Symptoms

The most easily recognized sign of genital HPV infection is genital warts. Genital warts are usually flesh-colored growths that can be raised, flat, or cauliflower-shaped. They can be small or large, and appear alone or in clusters. In males, they can appear on the surface of the penis, scrotum, thigh, groin, or in and around the anus. In females, warts can grow inside a woman's vagina, or on the cervix, making them hard to see. Most people who have a genital HPV infection do not know they are infected because many types of the virus remain latent and cause no symptoms. Noticeable symptoms are warts over the genital areas of men and women, including the inner thighs and sometimes the inside of the mouth and throat.

The Different Types of HPV Warts

Common warts usually appear on the hands, but can appear anywhere.

Flat warts are generally found on the face and forehead. They are common in children, less common in teens, and rare in adults.

Genital warts are usually found on the genitals, in the pubic area, and in the area between the thighs, but they can also appear inside the vagina and anal canal.

Plantar warts are found on the soles of the feet.

Subungual and periungual warts appear under and around the fingernails or toenails.

Treatment

Although there is currently no medical cure for human papillomavirus infection, the benign lesions and warts these viruses cause can be treated. However, treatment for genital warts can be a painful process which can involve cutting, freezing, laser, or burning the warts with Trichloroacetic acid (TCA). Another treatment is loop electrosurgical excision procedure (LEEP), where tissue is removed using a hot wire loop. Even after treatment, genital warts can come back. In fact, twenty-five percent of cases come back within three months.

Market

In the United States, $1.7 billion is spent annually to treat HPV infections. The market for HPV can be broken down into three distinct categories:

Vaccines: Two vaccines are available to prevent infection by some HPV types: Gardasil, marketed by Merck; and Cervarix, marketed by GlaxoSmithKline. Both vaccines protect against initial infection for HPV types 16 and 18, which cause HPV cervical cancer. Both vaccines provide no protection to females who are already infected with HPV. The vaccines work best when given to females before their first sexual contact. Both vaccines are recommended for eleven- and twelve-year-old girls. The vaccines are given in a series of three shots. Between 2006 and the first half of 2009, sales of Gardasil were approximately $2.5 billion.

Prescription Drugs: Two drugs dominate the genital wart market: Aldara, originally marketed by 3M and since sold to Graceway Pharmaceuticals in 2006; and Podofilox marketed by Watson Pharmaceuticals. Neither drug treats the virus itself. They treat symptoms of the virus.

Over-the-counter medications: Three medications used to treat common warts (warts that are primarily found in the hand area) dominate the market: Dermisil, Condysil Gel, and Wartrol. All three remedies are available over-the-counter and can be found in most drug stores. It is estimated that the overall market for over-the-counter wart medications is a multi-million dollar market.  These medications are not recommended for genital warts.

Important Facts and Statistics

HPV is as common in men as in women.

HPV does not cause herpes.

Most people with genital HPV have no visible signs or symptoms.

Genital HPV is the most common sexually transmitted infection (STI) in the United States.

About two out of three people will get genital warts after having any kind of genital contact with someone infected.

One of the most astounding scientific realizations of the last fifty years was that cancer could be caused by an infectious disease, specifically, one caused by human papillomavirus (HPV). Before the 1980's the idea that people could transmit cancer to each other was considered ludicrous by most people in the scientific community. However, HPV would soon prove them wrong. It is now widely accepted that HPV causes ninety-nine percent of cervical cancers.

While vaccines have proven to be effective, they only work before an individual is exposed to the virus. After exposure, vaccines have no therapeutic effect.

The American Cancer Society estimates that in 2010 about 12, 200 women in the United States will be diagnosed with invasive cervical cancer, and about 4,210 women in the United States will die from the disease.

In the United States, cervical cancer occurs in Hispanic women at a rate that is twice that for non-Hispanic women.

Starting at age twenty-one, women should have a Pap test every two years. Women age thirty and older who have had three normal Pap test in a row should have the test performed every three years.

A Pap test can find changes on the cervix caused by HPV.

HPV has been linked to certain types of skin cancer as well as throat cancer, anal cancer, penile cancer, and cervical cancer.

Cervical cancer was once the leading cause of cancer-related death in women in the United States. However, the Pap smear test has helped to dramatically reduce overall deaths. Nevertheless, it is still the fifth leading cause of cancer-related deaths among women.

Gay men are seventeen times more likely to develop anal cancer than heterosexual men.

Women, especially young women, have the highest known levels of HPV infections. An average of fourteen percent of American female college students get infected with genital HPV each year.

An average of twenty-eight to forty-six percent of women under the age of twenty-five are infected with genital HPV.

About NIAID

NIAID is a component of the National Institutes of Health (NIH) our Nation's Medical Research Agency. NIH is the primary federal agency for conducting and supporting basic clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. NIAID supports basic and applied research to prevent, diagnose, and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria, and illness from potential agents of bioterrorism.

About Tamir Biotechnology, Inc.

Tamir Biotechnology, Inc. (formerly Alfacell Corporation) is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE®, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of therapies for cancer, viral, and other life-threatening diseases. Currently, Tamir is conducting a Phase II clinical trial with the addition of RANPIRNASE (ONCONASE®) to PEMETREXED plus CARBOPLATIN in patients with non-squamous, non-small cell lung cancer (NSCLC).

ONCONASE® is a first-in-class therapeutic based on Tamir's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE® has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE® triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.

Tamir's proprietary drug discovery program is also the basis for the development of recombinant designed RNases for chemical conjugation and fusion (gene and protein) products with various targeting moieties, such as monoclonal antibodies, growth factors, and cytokines. This program also provides for joint design and development of new products with outside partners seeking line-extensions and/or improvements of the therapeutic effectiveness of their existing products. The reproducibility of our conjugation and fusion methodologies and the stability of these products has been demonstrated, and thus can be produced in a cost-effective and controlled manufacturing environment. For more information, visit www.tamirbio.com.  

Safe Harbor: This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainty whether the clinical trial results will allow the company to complete submission of a New Drug Application and if a New Drug Application submission is completed, uncertainty whether FDA will file or approve such application, uncertainties involved in transitioning from concept to product, uncertainties involving the ability of the company to finance research and development activities, potential challenges to or violations of patents, uncertainties regarding the outcome of clinical trials or differences of opinion in interpreting the results of clinical trials, the company's ability to secure necessary approvals from regulatory agencies, dependence upon third-party vendors, and other risks discussed in the company's periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the company undertakes no obligation to update these statements for revisions or changes after the date of this release.

SOURCE Tamir Biotechnology, Inc.