The BioBalance Corp reported results of a randomized clinical study in which a formulation containing its proprietary biotherapeutic agent, Probactrix, appeared to rapidly and effectively control diarrhea and other abdominal symptoms commonly associated with HIV infections and treatment. Refractory diarrhea will develop in a large portion of the 1 million Americans infected with HIV sometime during their illness.
Clinical trials were performed on 50 patients undergoing a standard course of HIV therapy, with 30 patients in the Probactrix treatment group and twenty in the control group. Both groups were comparable in terms of HIV infection stage. The trial was conducted at the Moscow Center Of HIV. The trial was run by Professor Ua Vengerov.
Results showed that the product significantly reduced gastrointestinal complaints in as early as three to five days after initiation of Probactrix. Within ten days of treatment, diarrhea symptoms were markedly reduced or totally disappeared in the treatment arm, but not in the control group. In the treatment arm, there was significant improvement noted in bowel movement frequency during therapy (p<0.001), and one month after stopping administration of the Probactrix formulation (p<0.01). Importantly, 70% of patients in the treatment group reported no GI problems one month after their last dose of Probactrix. Overall, the treatment group showed significant improvement in quality-of-life measures such as improved appetite and general well being. The product was well tolerated with no reported side effects.
While AIDS diarrhea can be life threatening due to dehydration, it can also result in delays in treatment and can significantly affect quality of life by making it difficult to maintain normal work and leisure activities. Because anti-viral medications have lengthened survival in AIDS patients, side effect management is becoming increasingly more important.
Dennis O'Donnell, BioBalance's Chief Operating Officer stated, "based on the positive results of this study, The BioBalance Corporation plans to explore a prescription drug indication for AIDS-related diarrhea. We are excited by the broad clinical applications for our core technology."