Immunitor reports positive safety imm01 clinical trial against tuberculosis

Dec 30 2010

Immune Network Ltd., advises that Immunitor has published data from the first half of the 120-patient imm01 clinical trial of its V5 immunomodulator product against tuberculosis, including difficult-to-treat forms of the disease.

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 the 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 newly published study 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 safety and clinical efficacy 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 quickly - 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 Immunitor's 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 V5 patients vs. 1.07 kg in 67.9% of placebo patients. V5 also eliminated TB-associated fever in 100% vs. 39.3% of patients on placebo. Finally, V5 showed marked anti-inflammatory effect: erythrocyte sedimentation rate and leukocyte counts reverted back to within normal range in patients taking the Immunitor product. The relationship between anti-inflammatory property of V5 and bacterial clearance needs to be investigated further.

In addition to the anti-tuberculosis and positive clinical effects, Immunitor's V5 immunomodulator is also shown to reduce the hepatotoxicity induced by chemotherapy for TB, MDR-TB and XDR-TB. The serious adverse effects of TB drugs have important negative consequences on treatment options, not only causing direct damage to patient health but also decreasing the willingness of patients to comply with their TB treatment regimen. 

Addition of V5 has been shown to counter the hepatotoxicity of TB drugs. For this reason the combination of V5 with ATT (anti-tuberculosis therapy) 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 a drastically shorter, more efficacious and safer treatment solution. In addition, V5 is inexpensive; easy to administer; stable at tropical temperatures; and is made from readily available sources, 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. For additional information about Immunitor company, please visit www.immunitor.com.