Stirling Products (ASX: STI) has commenced two clinical trials following receipt of Ethics Approval.
In Nigeria, Stirling’s clinical and marketing partner has commenced a trial in two groups of AIDS patients: one with HIV alone and the other for those who have Mycobacterium TB co-infection (HIV/TB).
The recruitment of patients for the HIV alone arm of the study is complete and in the second arm HIV/TB patients are being recruited now.
Originally slated for 60 patients, the trial will now recruit a total of 120 patients. An interim patient and result analysis is planned and expected by around July 2010.
In the Ukraine, an initial trial on patients suffering from acute respiratory disease (ARD), comprising those with influenza virus infection is now nearing completion. The ARD multi-centre trial was launched in February with eight clinicians at four different clinical sites in the eastern region of Ukraine (Luhansk, Rubejnoe, Lisichansk, and Severodonetsk), with more than 120 patients already enrolled.
Early test results are not yet available, a subgroup analysis, including results for swine flu (influenza type A H1N1) is anticipated at trial completion.
The results of these separate trials, in Nigeria and the Ukraine, are expected to be published in peer-reviewed journals later this year.
These clinical trials were commissioned by Stirling to extend published results of prior clinical trials for these indications.
Results of a previous seasonal flu trial, presented at the Sixth World Congress on Vaccines, Immunization and Immunotherapy held in September 2008 in Milan, Italy, indicated that use of the botanical immunomodulator can significantly reduce the duration and severity of disease symptoms, with fewer associated medical complications.
Most of the clinical evidence for ImmunoXel (Dzherelo) stems from clinical experience in adjunct therapy of TB, including multi- (MDR) and extensively- (XDR) drug resistant forms of the disease.
In the Ukraine Dzherelo, the ImmunoXel predecessor product has been recommended by the Ministry of Health as an adjunct immunotherapy for more than 10 years.