Australian healthcare company Stirling Products Limited (ASX:STI) has entered into an agreement with Innovative Biotech Ltd. of Keffi, Nigeria and Maryland, USA to register, trial, and market Dzherelo, the clinical version of ImmunoXel in Nigeria and other regions of Africa.
Nigeria with a population of 140 million, like most other African countries has major TB and HIV infection rates.
Under the deal, Stirling will support some of the costs of product registration, as well as the clinical trial of its immunomodulator in patients with tuberculosis, HIV, and TB/HIV co-infection.
Innovative Biotech will assist in arranging the clinical trial and, subject to the results of the trial, will launch marketing and distribution in Nigeria and other African countries.
Dzherelo (Immunoxel) is a botanical preparation approved and registered for use in several countries in Asia and Africa.
The preparation has been the subject of over a dozen successful clinical trials in TB and drug resistant TB over the last 15 years.
The results of past clinical trials, which were all very positive, have been published in peer-reviewed medical journals.
In extended clinical studies involving more than 1,200 patients, Dzherelo has been to have shown significant effects:
1. Shortening (drastically) the required treatment period to achieve clearance of Mycobacterium and
2. Reversing the adverse (hepatic) effects of conventional anti-TB drugs,
3. Improving clinical endpoints such as weight gain and
4. Lower incidence of opportunistic infections, and improved quality of life.
Dzherelo has also been tested in AIDS patients in Ukraine, with promising results on T-lymphocyte profiles, favorable cytokine production and decreased viral load.
Dzherelo which is a potent immunomodulator has also demonstrated benefit in trials of other viral infections such flu and hepatitis viruses.
The new study to be conducted in Nigeria is designed to confirm and extend the positive results on TB/HIV co-infection that were observed in past trials.
The Nigerian Dzherelo trial in TB and HIV will have an interim analysis scheduled for halfway through the trial, at which point the company and its partner Innovative will recommend continuation of the trial and immediate commencement of patient treatment, especially for humanitarian reasons.
Dr Simon Agwale, the President of Innovative Biotech, advised that it was the extensive published track record of Dzherelo/Immunoxel in the treatment of TB in the Ukraine that started the demand among Nigerian clinicians to bring the product into Nigeria for a trial.
“The weight of data indicating beneficial effects of Dzherelo/Immunoxel in the treatment of TB, HIV, and even seasonal flu demands that further trials be carried out,” Dr Agwale said.
Dr Agwale is a highly respected virologist/vaccinologist with extensive clinical and basic research experience.