Immunitor Publishes Phase II Immunotherapy Trial in Treatment-failed TB Patients
- Category: Vaccines
- Published on Monday, 24 October 2011 22:48
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Immunitor has published highly promising results from a clinical trial of its immunotherapy for tuberculosis patients who repeatedly failed to respond to conventional TB drugs
VANCOUVER, Canada I October 15, 2011 I The results from a one-month clinical trial of immunotherapy of tuberculosis were published in the Open Journal of Immunology – an open access journal - with full text of article available at (http://www.scirp.org/journal/Home.aspx?JournalID=602). The study involved 48 TB patients who were treated for an average of six years with conventional TB drugs and failed to respond. As a result they were placed on so-called palliative therapy consisting of just two TB drugs, isoniazid and rifampicin. These patients were then given one daily pill of V5 immunomodulator in addition to their palliative treatment and checked after one month for the presence of Mycobacterium tuberculosis in their sputum. Surprisingly 30 patients (62.5%) had cleared TB-causing bacterium and their clinical symptoms improved significantly. Increased weight gain and reduced fever and inflammation biomarkers associated with TB were most common signs of improvement.
Tuberculosis has again become a global public health priority. Currently available chemotherapies for the treatment of TB are not ideal. The length of therapy, coupled with side effects, often results in poor patient adherence, treatment failure, and the emergence of drug resistance. Current so-called short-course chemotherapy still requires 6 months, with isoniazid, rifampicin, pyrazinamide and ethambutol during first 2 months of intensive phase and isoniazid and rifampicin for continuation phase. No effective treatment options are available for those who failed to respond. Even more potent 2nd line TB drugs used for as long as 2 years are ineffective in such a situation. New approaches are urgently needed to shorten treatment duration and increase cure rates. Although several new drugs are now in pipeline, it is unlikely that a useful therapy will emerge soon. All this necessitates formulation of novel strategies to combat TB; one of them is to find simplified treatment regimens among existing drugs, which is a major priority of the Global Plan to Stop TB.
The idea that immunotherapy might improve treatment outcomes started gaining consensus in recent years. "We have been working with various immunotherapy approaches for TB and AIDS for more than ten years and despite our extensive experience with this type of therapy the results are simply breathtaking. We have not expected that treatment-failed TB patients will convert at such a rate within just one month after study initiation” said Dr. Galyna Kutsyna, principal investigator of this multi-site study conducted in Ukraine. The newly published study adds more weight to this consensus and supports earlier published phase 2 studies of V5 in patients with TB including those who had multi-drug resistant MDR-TB and TB with HIV co-infection.
Immunitor is dedicated to treatment of immunity-dependent diseases based on its clinically-validated proprietary oral delivery technology to employ the patient's own mucosal immune system. The patented technology platform of Immunitor is applied to vaccines and immunotherapies. Prior issued and pending Immunitor patents cover vaccines against microbial and fungal infections, HIV, hepatitis B, hepatitis C, influenza, tuberculosis, cancer and atherosclerosis. For more information about Immunitor, please visit http://www.immunitor.com.