Final Outcome Of One-month Immunotherapy Trial Published
/EINPresswire.com/ Vancouver, Canada, August 5, 2012 -- Immune Network Ltd. (IMMFF), announces the publication of randomized, placebo-controlled, double-blinded Phase IIb trial of a once-daily V5 pill in patients with tuberculosis.
The study involving 123 patients with TB appeared in July issue of London-based Immunotherapy journal. Two preliminary reports from this multisite trial comprising a total of 88 patients were already published, which indicated that V5 was safe and consistently enhanced the efficacy of TB drugs. Since then additional data from 35 patients has become available and present study summarizes the final outcome from originally planned 120 patients' study. The imm01 study was aimed to seek whether oral formulation of V5 in combination with standard TB chemotherapy can shorten TB treatment duration in tuberculosis patients, including drug-sensitive and drug-resistant TB. This registered study NCT01222338, has shown that daily administration of oral doses of V5 with TB drugs resulted in clearance of M. tuberculosis in sputum smears within one month.
After 1 month, 55 out of 62 patients (88.7%) became sputum smear-negative in the V5 arm (p < 0.0001), whereas in the placebo group, only nine out of 61 (14.8%) had converted. The conversion rate among V5 recipients was similar, regardless of whether TB was drug-sensitive, drug-resistant or with HIV co-infection - the proportion of converted patients and time to conversion were identical. About 92% of patients in V5 arm gained on average 2.9 kg versus 54% in control who gained 0.8 kg. It was of interest that the beneficial action of V5 was invariably associated with potent anti-inflammatory effect.
Current TB drugs are outdated and not fully effective, especially against multi-drug resistant TB (MDR-TB) and TB with HIV and strenuous and often-toxic treatment regimens lasting up to 3 years are required. However, there is a hope that new TB drugs might both reduce treatment duration and be effective against MDR-TB. The TB Alliance, a non-profit research organization dedicated to development of TB drugs, recently published study in Lancet, which has shown that 99% of TB bacteria are killed within 2 weeks. In view of the current global TB crisis, simple and short drug regimens are highly desirable because they will be potentially safer, cheaper, easier to take, well tolerated, and effective. Very few companies are engaged in developing therapeutic TB vaccination or immunotherapy such as V5.
"We are very pleased to publish the final results of our therapeutic TB vaccine study. It is extremely satisfactory to have a positive outcome in such a short time. The concept of immunotherapy for TB is catching up. We now look forward to a day when this and other immunotherapeutic interventions will be available as widely as possible," said Dr. Dmytro Butov, the Principal Investigator of the study.
Safe Harbor Statement
The information in this release, other than historical information, may be considered forward-looking statements. Projection and other forward-looking statements and management expectations regarding future events and/or financial performance of the Company -- although given in good faith -- are inherently uncertain and actual events and/or results may differ materially.
Immune Network Ltd. (IMMFF)
Media Contact:
Aldar Bourinbaiar
Immunitor
301 476 0930
PR courtesy of Online PR Media.
The study involving 123 patients with TB appeared in July issue of London-based Immunotherapy journal. Two preliminary reports from this multisite trial comprising a total of 88 patients were already published, which indicated that V5 was safe and consistently enhanced the efficacy of TB drugs. Since then additional data from 35 patients has become available and present study summarizes the final outcome from originally planned 120 patients' study. The imm01 study was aimed to seek whether oral formulation of V5 in combination with standard TB chemotherapy can shorten TB treatment duration in tuberculosis patients, including drug-sensitive and drug-resistant TB. This registered study NCT01222338, has shown that daily administration of oral doses of V5 with TB drugs resulted in clearance of M. tuberculosis in sputum smears within one month.
After 1 month, 55 out of 62 patients (88.7%) became sputum smear-negative in the V5 arm (p < 0.0001), whereas in the placebo group, only nine out of 61 (14.8%) had converted. The conversion rate among V5 recipients was similar, regardless of whether TB was drug-sensitive, drug-resistant or with HIV co-infection - the proportion of converted patients and time to conversion were identical. About 92% of patients in V5 arm gained on average 2.9 kg versus 54% in control who gained 0.8 kg. It was of interest that the beneficial action of V5 was invariably associated with potent anti-inflammatory effect.
Current TB drugs are outdated and not fully effective, especially against multi-drug resistant TB (MDR-TB) and TB with HIV and strenuous and often-toxic treatment regimens lasting up to 3 years are required. However, there is a hope that new TB drugs might both reduce treatment duration and be effective against MDR-TB. The TB Alliance, a non-profit research organization dedicated to development of TB drugs, recently published study in Lancet, which has shown that 99% of TB bacteria are killed within 2 weeks. In view of the current global TB crisis, simple and short drug regimens are highly desirable because they will be potentially safer, cheaper, easier to take, well tolerated, and effective. Very few companies are engaged in developing therapeutic TB vaccination or immunotherapy such as V5.
"We are very pleased to publish the final results of our therapeutic TB vaccine study. It is extremely satisfactory to have a positive outcome in such a short time. The concept of immunotherapy for TB is catching up. We now look forward to a day when this and other immunotherapeutic interventions will be available as widely as possible," said Dr. Dmytro Butov, the Principal Investigator of the study.
Safe Harbor Statement
The information in this release, other than historical information, may be considered forward-looking statements. Projection and other forward-looking statements and management expectations regarding future events and/or financial performance of the Company -- although given in good faith -- are inherently uncertain and actual events and/or results may differ materially.
Immune Network Ltd. (IMMFF)
Media Contact:
Aldar Bourinbaiar
Immunitor
301 476 0930
PR courtesy of Online PR Media.
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