Immunitor completes V5 Phase IIb imm01 clinical trial enrollment for TB

Immune Network Ltd. (Pink Sheets:IMMFF), advises that its potential acquisition, Immunitor USA Inc., has announced the completion of enrollment in its Phase IIb imm01 clinical trial of V5 in tuberculosis. Immunitor's innovative and proprietary investigational candidate V5 vaccine is being developed as an adjunct TB immunotherapy to treat tuberculosis in combination with standard TB drugs. Immunitor initiated the imm01 trial earlier this year and expects to have final data in the first quarter of 2011.

"We are very pleased to complete enrollment of this trial on schedule. Given the size of commercial opportunity for V5 and marketing efforts that will be required, it is our intention to seek a partner to undertake the later stage development and commercialization of this product. We very much look forward seeing published results from this study in near future," said Dr. Aldar Bourinbaiar, Chief Executive Officer of Immunitor.

The WHO-recommended standard "short" course treatment for TB is daily doses of isoniazid, rifampicin, pyrazinamide, and ethambutol for two months (high-intensity phase), followed by a continuation phase consisting of isoniazid and rifampicin three times per week for a further four months. Many patients with ordinary TB struggle to finish their six-month treatment program, while those infected with multi-drug-resistant strains need treatment for up to two years. Because of such long duration and the high incidence of drug side effects, the compliance is poor, and the cost of the 2nd-line drugs used against resistant TB is high. Drug resistant strains of TB are a current and emerging global health threat. More than half a million cases of drug-resistant TB emerge yearly. Treatment for MDR-TB cures only 50-70% of cases, and requires 18-24 months of complicated, expensive, and often toxic combination therapy.

Immunitor is now taking steps to initiate another Phase II trial which aims to seek whether a one-month combination of V5 with conventional drugs isoniazid and rifampicin can clear TB bacteria. The trial is planned to involve 60 participants at three centers in Ukraine, patients will be randomized at 1:1 ratio, each group receiving either V5 or placebo for one month followed by evaluation of effectiveness, safety, and tolerability. In view of the current global problem with TB this simple regimen is highly desirable because it is safer, cheaper, easier to take, well tolerated, and effective. The preliminary data from imm01 trial indicate that this simple combination appears to be as effective as the more complex five anti-TB drug combination in treating MDR-TB.

"If these preliminary observations are found to be true - this could be tremendous news to our patients. This approach will simplify therapy and shorten the treatment duration. Also doctors would not need to do time-consuming and costly tests to determine whether patients had drug-resistant strains before starting treatment," said Vichai Jirathitikal, who reviewed the preliminary data. Vichai is the co-inventor of V5 and co-owner of Immunitor company, which was founded in College Park, Maryland in 2004. For additional information about Immunitor company, please visit http://www.immunitor.com/.

Immunitor is also planning a pivotal Phase III placebo-controlled, randomized trial in India to demonstrate the efficacy and safety in 300 patients with TB. ECCRO (http://www.eccro.com/), the premier India specialist CRO for international Phase II - IV clinical trials, has been advising Immunitor on the design and conduct of the trial, the results of which would contribute to the product's global marketing authorization. In India TB is a health threat of great importance, accounting for one-fifth of the global cases of TB, killing two persons every 3 minutes. The country has 2.2 million new cases every year, out of which 1 million are contagious, smear positive pulmonary cases.

Results from an initial open label Phase 2 trial in 20 patients with TB who simultaneously had HIV and hepatitis C virus (HCV) co-infections were recently published in the Journal of Vaccines & Vaccination (http://omicsonline.org/2157-7560/2157-7560-1-103.php), triggering worldwide interest in V5. Immune Network is continuing its work toward meeting the pre-conditions of regulatory compliance and other updating of corporate issues in order to complete a merger with Immunitor.

Source: Immune Network 

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