VANCOUVER, British Columbia, February 01, 2020
Immunitor Inc., commercial-stage biotech company, is pleased to announce the publication of positive results from the randomized, placebo-controlled Phase III clinical trial for Tubivac (V7), the first-in-class, orally-available therapeutic vaccine used as an immune adjunct for the chemotherapy of tuberculosis (TB). Tubivac consists of inactivated non-pathogenic strain of Mycobacterium vaccae, which is related to Mycobacterium tuberculosis – the pathogen that causes tuberculosis – most prevalent infectious disease affecting 10 million people every year. In addition, approximately 2 billion people, equivalent to roughly one quarter of the global population, are estimated to harbor a latent TB infection and therefore at risk of progressing to overt tuberculosis. The global spread of multi-drug-resistant (MDR) strains and co-infection with HIV also contributes to the challenges of treating TB – top infection in the world that killed 1.5 million people in 2018. The daily pill of Tubivac taken along with standard TB drugs has cleared TB bacteria within one month – the shortest treatment course available today. Currently, 6 months is required to treat drug-sensitive TB and at least 12 months for MDR-TB, which benefits 85% and 50% of patients respectively – the rates Tubivac can achieve after just one month.
The published trial confirmed safety and efficacy of two earlier Phase II studies of V7 at same 10 microgram per dosage strength. “This is first-ever TB vaccine available as a low-cost pill”, said Dr. Aldar Bourinbaiar, CEO of Immunitor. “Tubivac is a result of our earnest effort to address the unmet need for faster-acting regimens to treat all forms of tuberculosis including drug-resistant TB and TB with HIV. The anti-TB property of Mycobacterium vaccae strain used in this trial was first discovered in 1972 by Cynthia and John Stanford during Buruli ulcer outbreak in Uganda. The positive data from our trial, published in Elsevier’s Journal of Clinical Tuberculosis and Other Mycobacterial Diseases is a culmination of 10 years of altruistic endeavor aimed at developing oral immunotherapy with a novel mechanism of action that can alleviate suffering of people with TB. Our study has shown that Tubivac helps gain weight, reduce inflammation, and can counteract hepatotoxicity commonly caused by TB drugs. In addition, our clinical experience shows that Tubivac has a potential to treat asthma, emphysema, COPD, lung cancer and fibrosis - other serious medical conditions affecting lungs. Nothing principally new, since introduction of BCG vaccine in 1921 and deployment of TB antibiotics from 1940’s, has been developed to eradicate TB, which remains the number one killer disease today. Tubivac is faster, safer and cheaper of any TB interventions introduced so far and poised to be the paradigm shifter.”
About Immunitor
Canada-based Immunitor is a private biopharmaceutical company with affiliations in USA, Russia, China, Hong Kong, Ukraine, Mongolia and South Africa. Immunitor has developed unique oral delivery platform and is among top ten oral vaccine companies globally. Company has an extensive pipeline of twenty two oral immunotherapy products at various stages of development, including several already commercialized. Immunitor’s therapeutic vaccines are made as ordinary appearing pills stable at room temperature for years. They are broadly split into three clinical categories: infectious diseases; viral, bacterial, fungal and protozoan, metabolic/autoimmune/inflammatory disorders; atherosclerosis, diabetes, obesity, hypertension, psoriasis, endometriosis, etc. and oncology indications, e.g., cancers affecting lungs, breast, liver, pancreas, gallbladder ducts, GI tract, kidneys, ovaries, cervix, brain, multiple myeloma, etc. The development of three products was supported by Global Grand Challenges initiative from Bill and Melinda Gates Foundation, financed by the government of Canada. Immunitor currently offers for sale Ukrainian-made Immunoxel (Dzherelo) – immunomodulating phytoconcentrate and in-house developed Tubimod (V5), both of which were shown in Phase III trials to reduce the duration of TB treatment down to one month. Tubivac (V7) is yet another proprietary, orally formulated anti-TB orphan drug with shorter treatment duration. The injectable form of M. vaccae has been through over hundred clinical trials in more than 20 countries since 1980’s – however this inconvenient-to-use formula is twice-less effective and sold in China under VACCAE trademark by Anhui Zhifei Longcom – a company that has been inspired by John Stanford’s pioneering work. For more information, please write at info@immunitor.com.
Source: Immunitor Inc.