The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials in intended registration countries, such as China, Russia and South Africa, etc.

Start Date01 Mar 2014

Sponsor / Collaborator

Immunitor, Inc.

[+3]

NCT01380119 / CompletedPhase 2IIT

Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients

This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.

Start Date01 Aug 2011

Sponsor / Collaborator

Immunitor USA Inc.

[+1]

NCT01222338 / CompletedPhase 2IIT

Phase 2 Placebo-controlled, Randomized Study of Oral Immunomodulator in TB and TB/HIV Patients

Treatment of multidrug-resistant TB (MDR-TB) is 100 times more expensive than treatment of drug-susceptible TB, requiring intensive clinical management for prolonged time (18-24 months) and more toxic treatment course. In prior open label study the investigators have shown that adding V-5 Immunitor (V5), can reduce treatment duration to one month and enhance by 4-5 fold the efficacy of TB drugs. Furthermore, V5 has been shown to reverse or reduce liver damage caused by chemotherapy. The cost of V5 will be very modest. The investigators propose to conduct placebo-controlled clinical trial in patients with treatment refractory TB so that the clinical benefit of V5 is confirmed.

Start Date01 Jan 2010

Sponsor / Collaborator

Immunitor USA Inc.

[+1]

100 Clinical Results associated with Immunitor USA Inc.

0 Patents (Medical) associated with Immunitor USA Inc.

Literatures (Medical) associated with Immunitor USA Inc.

01 Jul 2012·ImmunotherapyQ4 · MEDICINE

Adjunct Immune Therapy of First-Diagnosed TB, Relapsed TB, Treatment-Failed TB, Multidrug-Resistant TB and TB/HIV

Q4 · MEDICINE

Article

Author: Bourinbaiar, Aldar S ; Sokolenko, Nina I ; Jirathitikal, Vichai ; Yurchenko, Larisa I ; Butova, Tatiana S ; Stepanenko, Anna L ; Efremenko, Yuri V ; Butov, Dmytro A ; Arjanova, Olga V ; Kutsyna, Galyna A ; Zaitzeva, Svetlana S ; Prihoda, Natalia D

Aim: To evaluate the effect of an adjunct immunotherapy in randomized double-blind, placebo-controlled Phase IIb trial involving 123 TB patients. Methods: Patients were randomly allocated into two arms: one (n = 62) received a once-daily pill of V-5 Immunitor™ (V5) and the other (control; n= 61) received placebo for 30 days in addition to first- or second-line TB drugs administered under directly observed therapy. The subjects in V5 and placebo arms had first-diagnosed, relapsed, treatment-failed and multidrug-resistant TB at ratios of 17:21:11:13 and 20:19:14:8, respectively; among them, ten and seven had HIV coinfection, respectively. Results: 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, 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. V5 downregulated TB-associated inflammation, as shown by the normalization of elevated leukocyte counts (8.7 vs 6.3 × 10 9/l; p < 0.0001) and decreased erythrocyte sedimentation rate (22.8 vs 12.6 mm/h; p < 0.0001), whereas among placebo recipients, changes were smaller (8.9 vs 8.2 × 10 9/l and 25.1 vs 19.9 mm/h). Thirty three (54.1%) placebo patients gained on average 0.8 kg (p = 0.0002); by contrast, 57 (91.9%) out of 62 patients in the V5 group gained a mean weight of 2.9 kg (p < 0.0001). No adverse side effects or reactivation of TB were seen at any time. Conclusion: V5 is safe and effective as an immune adjunct to chemotherapy for TB and can potentially reduce the treatment duration down to 1 month.

01 Mar 2012·ImmunotherapyQ4 · MEDICINE

Clinical Validation of Sublingual Formulations of Immunoxel (Dzherelo) as an Adjuvant Immunotherapy in Treatment of TB Patients

Q4 · MEDICINE

Article

Author: Rowe, John ; Efremenko, Yuri V ; Kutsyna, Galyna A ; Mospan, Igor V ; Pylypchuk, Volodymyr S ; Bourinbaiar, Aldar S ; Arjanova, Olga V ; Yurchenko, Larisa V ; Sokolenko, Nina I ; Prihoda, Natalia D ; Jirathitikal, Vichai

Immunoxel (Dzherelo) is a water–alcohol extract of medicinal plants used in Ukraine as an adjunct immunotherapy to TB and HIV therapy. Four types of solid sublingual formulations of Immunoxel were made: sugar dragées, sugar-coated pills, gelatin pastilles and dried-honey lozenges. They were administered once-daily along with TB drugs. After 1 month, 84.1% of TB patients became sputum-negative with rates in individual groups of 89.5, 70, 76.9 and 100%, respectively. The conversion rate was independent of bodyweight, age, gender, differences in chemotherapy regimens or whether subjects had newly diagnosed TB, re-treated TB, multidrug-resistant TB or TB with HIV coinfection. Patients experienced earlier clinical improvement, faster defervescence, weight gain, a higher hemoglobin content and reduced inflammation as evidenced by lower leukocyte counts and erythrocyte sedimentation rate. By contrast, in the placebo group, only 19% of patients had converted. These findings imply that mucosal delivery of solid Immunoxel is equivalent to the original liquid formula given per os twice-daily for 2–4 months.

01 Feb 2011·ImmunotherapyQ4 · MEDICINE

Adjunct Oral Immunotherapy in Patients with Re-Treated, Multidrug-Resistant or HIV-Coinfected TB

Q4 · MEDICINE

Article

Author: Batdelger, Dendev ; Yurchenko, Larisa V ; Arjanova, Olga V ; Frolov, Valery M ; Prihoda, Nathalia D ; Sokolenko, Nina I ; Tarakanovskaya, Marina G ; Bourinbaiar, Aldar S ; Jirathitikal, Vichai

This Phase IIb, placebo-controlled study involved 55 TB patients treated with anti-TB therapy. They were divided into two groups, matched by age, gender, baseline bodyweight and clinical manifestations: one group (n = 27) received a once-daily V-5 Immunitor (V5) immunotherapy pill and the other (n = 28) received placebo. Only one (3.7%) and three (10.7%) subjects in V5 and placebo arms, respectively had first-diagnosed, drug-sensitive TB; the remaining patients had re-treated TB, multidrug-resistant TB or HIV–TB coinfection. After 1 month, 26 out of 27 patients (96.3%) became sputum smear negative in the V5 group (p < 0.0000001), whereas seven out of 28 (25%) in the placebo group had converted (p = 0.005). V5 contributed to the downregulation of TB-associated inflammation, as shown by normalization of high leukocyte counts, erythrocyte sedimentation rate and faster defervescence than controls. Patients in both arms experienced an increase in the levels of hemoglobin corresponding to 128.9 ± 17.6 versus 133.1 ± 14.7 g/l (p = 0.03) and 112.6 ± 14 versus 117 ± 11.7 g/l (p = 0.03) in V5 and placebo arms, respectively. In total, 19 out of 28 placebo patients (67.9%) gained, on average, 1.07 kg (59.1 ± 10 vs 60.1 ± 10.4 kg; p = 0.003). By contrast, all patients in the V5 group gained weight with mean 3.4 kg (59.7 ± 8 vs 63.1 ± 9 kg; p = 5.7E-007). Clinical symptoms improved among all patients in V5 arm, while 28.6% of patients on placebo reported satisfactory results (p = 0.007). No adverse or side effects attributable to V5 were seen at any time. Further studies are needed to gauge the extent of the benefits of V5 as safe and effective adjunct immunotherapy for TB.

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