To determine the effectiveness of a drug, NIAID uses a Selectivity Index (SI) as criteria to determine the potency of a drug. The SI measures CC50 (amount of drug required to kill 50% of uninfected cells) and EC50 (amount of drug needed to cause 50% inhibition of viral replication). CC50 divided by EC50=SI. The in vitro results, which were performed in cell culture and in plaque reduction assay (the gold standard) showed significant and potent antiviral effect in a head- to- head comparison against Ganciclovir, which is marketed by Roche and generated revenues of $546 million in 2008. (For test results click the following link) http://www.tamirbio.com/Comparing_Onconase_and_P31_to_Ganciclovir_against_Human_Cytomegalovirus.html
Within the last several months, we have reported significant results for our compounds against Dengue Fever, Yellow Fever, SARS, and now CMV. We are on the cusp of building an impressive drug 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.
In the case of CMV, where toxicity is of primary concern for current approved drugs, this has not been the case in the studies performed with our drugs. Moreover, Onconase®, our lead candidate, has been in clinical studies for other indications and has proven to be well tolerated in over 1,000 patients treated to date. NIAID will now be conducting animal studies for Dengue Fever, Yellow Fever, SARS, and CMV. Our goal is to enter into clinical trials for these viruses in the near future. "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 Cytomegalovirus (CMV)
CMV is a member of the herpesvirus family. This family of viruses also causes chicken pox, shingles, mononucleosis (mono), genital herpes, and cold sores. In the United States, between 50% and 85% of the population will become infected with CMV by the time they reach age forty. Once a person is infected, the virus will remain alive, but dormant in their body for life. In most cases, CMV does not cause disease. However, CMV can cause severe and occasionally life-threatening disease in people with weakened immune systems.
Who's at Risk
Patients with weakened immune systems and patients receiving drugs to suppress their immune system, such as:
- Solid Organ Transplant Recipients
- Bone Marrow Transplant Recipients
- Cancer Patients
- Patients with HIV/AIDS (CMV Retinitis)
- Babies Infected With CMV Before Birth (Congenital CMV)
How Is CMV Spread
CMV is spread from person to person through close contact with body fluids, such as urine, blood, saliva, semen, vaginal fluids, and breast milk.
Signs and Symptoms
Active infection can cause prolonged high fever, pneumonia, blindness, diarrhea, liver infection, kidney damage, chills, fatigue, headache, enlarged spleen, and encephalitis.
Treatment
Currently, Ganciclovir is the drug of choice for CMV disease. Other approved drugs include Cidofovir and Foscarnet. These drugs are used judiciously and handled as a cytotoxic drug in the clinical setting. None of the currently approved drugs for CMV have proven to be well tolerated. Ganciclovir is commonly associated with a range of serious hematological adverse effects. It is also considered a potential human carcinogen.
CMV Market
In 2008, the market for CMV drugs was $600 million with Ganciclovir controlling over 90% of the market. Leading industry observers estimate that sales for CMV disease would top one billion dollars in sales if there were a drug available that was both safe and effective. Many patients currently taking drugs approved for CMV disease will require a kidney transplant due to the serious toxicities associated with these drugs.
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 targeted therapies for cancer, viruses, and other life-threatening diseases. 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.
| CONTACT: | Tamir Biotechnology, Inc. | |
| Charles Muniz, President, CEO and CFO | ||
| 732-823-1003 X 203 | ||
SOURCE Tamir Biotechnology, Inc.
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