http://clinicaltrials.gov/ct2/show/NCT01222338). The article entitled "Adjunct oral immunotherapy in patients with re-treated, multidrug-resistant or HIV-coinfected TB" appeared as e-publication ahead of print in peer-reviewed, high-impact Immunotherapy journal. The link to the abstract of paper is available at http://www.ncbi.nlm.nih.gov/pubmed/21182457.
The study, which was conducted by internationally recognized experts in the field of TB immunotherapy, Dr. Olga Arjanova and her team at Lisichansk TB Dispensary in the Eastern Ukraine, aimed to compare the impact of V5 immunotherapy to placebo among treatment refractory tuberculosis cases including re-treated TB, multi-drug resistant (MDR-TB) and TB with HIV co-infection.
The results of the published study which analyzed first 55 enrolled patients support findings from the earlier published open label trial that appeared in October of this year in the Journal of Vaccines and Vaccination and provide further evidence of clinical benefit of V5.
The imm01 study indicated that V5 was safe, has not produced any adverse effects or reactivation of TB. Concurrent administration of V5 either with 1st- or 2nd-line TB drugs resulted in clearance of M. tuberculosis in sputum smears of 96.3% patients as opposed to 25% among placebo recipients. Sputum conversion occurred very fast - only one month of treatment was needed. No difference was seen when "regular" easy-to-treat TB was compared to re-treated TB, MDR-TB or HIV-TB - the proportion of converted patients and time to conversion were identical. Another significant observation worthy of note is that the outcome appeared to be the same, regardless whether 1st line or 2nd line TB drugs were used.
One pill of V5 given once-per-day produced other statistically significant clinical benefits. V5 reversed TB-associated wasting; average weight gain was 3.4 kg in 100% of patients vs. 1.07 kg in 67.9% in placebo. V5 eliminated TB-associated fever in 100% vs. 39.3% of patients on placebo. V5 has shown marked anti-inflammatory effect. Erythrocyte sedimentation rate and leukocyte counts reverted back to normal. The relationship between anti-inflammatory property of V5 and bacterial clearance needs to be investigated further. The hepatotoxicity induced by TB chemotherapy has serious adverse consequences to treated patients and imposes limitations on treatment options. Addition of V5 has been shown to counter the hepatotoxicity of TB drugs. For this reason the combination of V5 with ATT has an additional benefit of preventing or reversing drug-induced liver damage
"Remarkable anti-TB activity was discovered accidentally during clinical trial in patients with chronic hepatitis C who also happened to have Mycobacterium tuberculosis and HIV co-infections," said Aldar Bourinbaiar, CEO of Immunitor company. "The goal of Immunitor is to investigate in depth the properties of V5 and, in so doing, eventually develop a vaccine that could do both, treat and prevent TB.
After AIDS, tuberculosis is the second most common cause of death from an infectious disease, with approximately 2 million people dying each year. Current treatments are not fully effective, particularly against multi-drug resistant TB (MDR-TB) and HIV-TB and strenuous treatment regimens lasting for up to 2 years are required. "Immunitor's approach has the potential to address current challenges - offering drastically short and more efficacious and safer adjunct treatment. In addition, V5 is inexpensive; easy to administer; stable at ambient temperature; and is made from readily available source, which suits ideally developing countries where TB is rampant and patients are too poor to afford expensive 2nd line TB drugs" said Vichai Jirathitikal, co-founder and co-inventor of Immunitor oral vaccine platform.
Immunitor's future business partner Vancouver-based Immune Network is in final stages of its work toward meeting the conditions for a merger. Additional corporate details and terms for transaction with Immunitor will be announced shortly. A temporary website for Immune Network is at http://www.immune-network.com. The Immune Network Ltd. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8008. For additional information about Immunitor company and contact info, please visit www.immunitor.com.