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.
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.
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.
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.
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.
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.
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:
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.
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 Tamirbio!
SOURCE Tamir Biotechnology, Inc.