The New Delhi – based Arbro Pharmaceuticals will be conducting clinical trials on hepatitis C and HIV virus along with its partner company Qualtran Auriga Research, for US-based company Athlon Medical.
The aim of the study is to test the safety and efficacy of the Aethlon hemopurifier, a lectin affinity cartridge, in clearing hepatitis C virus (HCV) from the blood of HCV-positive end-stage renal disease patients undergoing dialysis. Institutional-review-board has sanctioned the clinical safety studies which were conducted at Apollo and Fortis Hospitals in India. The results have been published in peer-reviewed International Journal – Blood Purification 2009.
Dr. Atul Thatai, Vice President Biotechnology, Arbro Pharma said, “We are conducting this trial on behalf of Qualtran and it’s a mid-term trial which is going to see the efficacy of the device. The device is meant for the hepatitis C and HIV virus. The in-vitro studies were conducted by Athlon in the US while we are conducting a human trial in India. We are aiming to complete the trial in another year.
The company is measuring viral ribonucleic acid (RNA) through using real-time quantitative reverse transcriptase polymerase chain reaction. The hepatitis C virus (HCV) clearance from plasma or blood has measured via using direct capture on immobilized Galanthus nivalis agglutinin (GNA) or using miniature plasmapheresis cartridges containing immobilized GNA.
At Fortis, three patients treated three times/week for one week completed the viral load studies. Two patients showed measurable viral load reduction, while the third showed both increase and decrease in viral load. After Hemopurifier treatment, average HCV viral load was reduced by 57 percent. Surprisingly, an average viral load was also 82 percent lower seven days after treatment. Control samples also showed a marked transient reduction in HCV viral load as previously reported.
HCV in plasma samples was rapidly cleared by direct affinity capture (t 1/2 = approx. 20 min) and HCV in human blood was cleared using the hemopurifier (t 1/2 =2-3 h). At Apollo, four patients were treated three times weekly for two weeks. HCV captured on the hemopurifier averaged 8.9 x 108 viral copies/cartridge (n = 5), representing approximately 30 percent of the initial viral body burden.
The hemopurifier rapidly cleared HCV from blood treated in vitro. In patients, the combination of the hemopurifier plus dialysis decreased HCV viral load by 57 percent in one week. Moreover, viral load reduction continued up to seven days after treatment. Qualtran Auriga Research is undertaking hepatitis C virus and studies for testing the hemopurifier in HIV patients for Athlon Medical. n