Oral Immunotherapy for TB – Results of Breakthrough Study Published

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Immunitor USA Inc announces the results of its breakthrough study of adjunct immunotherapy of TB. The Phase II, open-label clinical trial revealed that the therapeutic immunization resulted in clearance of Mycobacterium tuberculosis in sputum smears of 94.4% of patients after just one month of therapy.

The results of this trial are exciting and certainly good news for people living in countries with high rates of TB and HIV. The discovery of novel therapies against tuberculosis is a major global health priority. We and our Ukrainian colleagues are extremely satisfied by the outcome of this study, which has all the signs of potential huge impact to the field

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Immunitor USA Inc., is pleased to report results of its first clinical trial showing that once-daily tablet of immunotherapeutic agent V5 in combination with tuberculosis drugs was safe and effective in treating TB patients who had concurrent chronic hepatitis C and HIV co-infections. The study appeared in the October, 2010 online issue of open access Journal of Vaccines and Vaccination (http://omicsonline.org/2157-7560/2157-7560-1-103.php).

Every patient who entered the study had enlarged liver, elevated hepatic damage markers, which at the end of study had improved in 19 out 20 (95%) patients. The reduction was highly significant, from 1.72±0.34 to 0.18±0.28 ¼mol/ml•h (P=5.0E-012) and 22.1±3.4 to 10.9±2.5 ¼M/L (P=5.7E-009) for alanine transaminase (ALT) and total bilirubin respectively. Enlarged liver reduced from 3.5±1.4 to 0.95±1.1 cm above normal size (P=2.9E-009). TB-associated fever subsided within mean/median 4.1/3 days. Other indicators of inflammation such as elevated erythrocyte sedimentation rate and high leukocyte counts returned back to normal from 32.3±11.4 to 9.9±6.4mm/h (P=3.7E-008) and 14.3±3.9 to 4.7±1.4x109L (P=7.1E-010) respectively. Average body weight gain was 7.7 kg (P=4.6E-007) and hemoglobin levels increased from 114±7.1 to 123.4±6.6 g/L (P=1.4E-007). No adverse events were observed at any time. As a result 17 out 20 enrolled patients (85%) were discharged from the hospital - an outcome that was completely unanticipated - considering that normally it takes at least 6 months to cure TB.

Today, one-third of the world's population — about 2 billion people — are believed to be infected with dormant or latent form of Mycobacterium tuberculosis, the microbe that causes TB. But people infected with TB bacilli will not necessarily become sick with the disease – only in a small proportion of these people the TB germ becomes active. According to the World Health Organization, an estimated 11.1 million people had the active form of the disease in 2008. The Centers for Disease Control and Prevention reported 12,898 cases of TB in the United States in 2008. TB is especially dangerous and is becoming more prevalent among people who have other infectious diseases, such as AIDS and hepatitis. In 2008, about 1.8 million people died of TB, including an estimated 500,000 people co-infected with HIV. Globally, TB is the world’s second most important cause of death from an infectious agent after HIV (malaria is third). The WHO's 2009 report on TB indicated that one in four tuberculosis deaths is HIV related, which is twice as many as had been recognized previously. TB patients with HIV are 30 times more likely to die and treatment options for them are limited.

Substantial efforts are underway in basic, translational and clinical science to expedite the development of new TB drugs, vaccines and diagnostics. There has been no new drug for TB for more than 40 years. It has been 90 years since the only available TB vaccine called Bacille Calmette Guerin (BCG) was introduced, and a new TB vaccine is long overdue. During last ten years about 13 new candidate vaccines have entered clinical trials in humans and over 40 are in the pipeline. One of these is expected to enter phase 3 efficacy trials by 2013 and if successful it may be rolled out by 2020. The BCG vaccine can reduce the risk of severe TB in young children but it is not very effective in preventing pulmonary TB in adolescents and adults, which are the populations with the highest rates of the disease. Furthermore, BCG is not effective when used as a therapeutic vaccine i.e., used in sick people who already have symptoms of the disease.

The only therapeutic TB vaccine that passed Phase III clinical stage is an inactivated Mycobacterium vaccae preparation, discovered by John and Cynthia Stanford, and which is being evaluated by the Aeras Global TB Vaccine Foundation in Rockville, Maryland, in collaboration with the London-based manufacturer, Immodulon Therapeutics. Another therapeutic vaccine called RUTI is made from heat-inactivated fragments of M. tuberculosis and planned for Phase II trial in South Africa by Archivel – a biotech company located in Spain. Other lesser known, but commercially available, immune modulators are M. phlei, M. bovis and leprosy vaccine M. w (Immuvac, Cadila Pharmaceuticals) – they have been used with various degrees of success in TB patients in China, Russia and India.

“The results of this trial are exciting and certainly good news for people living in countries with high rates of TB and HIV. The discovery of novel therapies against tuberculosis is a major global health priority. We and our Ukrainian colleagues are extremely satisfied by the outcome of this study, which has all the signs of potential huge impact to the field,” said Dr. Aldar Bourinbaiar, the CEO of Immunitor USA Inc. “This trial is another proof-of-concept for Immunitor’s oral vaccines platform based on principles of alloimmunization and immune tolerance – but is first to demonstrate that TB can be cleared so fast, especially in patients with deadly complications such as HIV and hepatitis C. The next studies will address the potential of V5 against drug-resistant TB in placebo-controlled setting”.

Multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB are spreading rapidly amid an already overwhelming burden of drug-sensitive TB and HIV/AIDS, particularly in resource-poor nations. The treatment of drug-resistant TB is not effective, requiring 24 months of treatment rather than the usual 6-9 months, and far more expensive -- costing an average of $5,000 per patient instead of $20 for “normal” TB. The interventions that can work to control these forms of TB represent the unmet medical need. “We need to challenge dogma and think outside the box’, said co-founder of the company and vaccine developer Mr. Vichai Jirathitikal, “our V5 is inexpensive, can cut treatment down to one month, and is equally effective against difficult-to-treat TB cases such as drug-resistant TB and HIV/TB. It was a total surprise that our immune therapy originally designed for management of chronic hepatitis B and C had shown such a potent effect in TB”.

About Immunitor USA, Inc.
Immunitor USA, Inc. is a privately held biopharmaceutical company with headquarters in College Park, MD (http://www.immunitor.com). Immunitor’s strength is a unique oral vaccine technology platform validated by clinical trials conducted over the past ten years. Immunitor produces several immunotherapies addressing major health targets: HIV, hepatitis B, hepatitis C, influenza, broad-spectrum microbial and fungal infections, autoimmune diseases, cancer and atherosclerosis / obesity. In September 2010, Immunitor and Vancouver-based public company Immune Network Ltd. (IMMFF:US) announced their intent of reverse merger – a subject to due-diligence and establishment of terms.

Aeras Global TB Vaccine Foundation
Centers for Disease Control and Prevention
World Health Organization

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Aldar Bourinbaiar
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