Prospective cohort study of HCV patients

In a study (Slesarev et al. New Probiotic Antioxidants for Patients with Hepatitis C. FALK Symposium “Liver Diseases: Advances in Treatment and Prevention”. Freiburg, Germany, October 17-19, 2009) that involved 16 patients with chronic hepatitis C and severe fatigue syndrome, ZL016 obtained by enzymatic hydrolysis of lactic acid bacterium’s peptidoglycan was administered orally to patients (see chart above). All except one patient responded extremely well to the treatment: serum GGT level was decreased by 41% (+/-6%) with concurrent several fold reduction of the elevated ALT, AST and virus titer after 9 weeks into taking orally 0.5 mg/kg of Zl016 daily. High levels of free iron, cholesterol, and triglycerides were also reduced. No side effects were observed. In all patients with severe fatigue, a drastic improvement in the quality of life was noticed. In parallel, a beneficial effect on leucopenia and thrombocytopenia was documented.
 

 

 

Case Study: Eradication of HCV Genotype 3 in 45 Years Old Male

A 45 year old white business man was first found to have abnormal biochemical liver tests in 2011. He went to see his physician for a checkup following his release from an orthopedic trauma surgery clinic where he was treated after a major car accident. He received blood transfusions during the treatment in the clinic. The patient was referred to a hepatologist after undergoing testing and was found positive for hepatitis C, genotype 3. The patient was unaware of acute infection due to its asymptomatic presentation. He felt well and denied any history of gastrointestinal bleeding, encephalopathy, or abdominal swelling; he occasionally drank in high excess. A non-invasive assessment of liver fibrosis with transient elastography (FibroScan) and the serological fibrosis marker FibroTest showed grade 1 activity and F2 fibrosis (METAVIR). He refused combined pegIFN and RBV therapy and in May 2011 was subsequently put on 20 mg daily dose of the probiotic glycopeptide ZL016. 18 weeks into the regimen, he was cleared of the virus and his transaminases returned to normal (see chart above). He continues taking ZL016 and performs regular checkups. He has remained virus free ever since. In 2015, three years after his first liver examination, he repeated FibroScan and FibroTest that revealed no signs of fibrosis.

Case Study: Viral Aplastic Aneamia 

Patient S. 18 years old, was complaining about significant fatigue and prolonged bleeding during her menses. Additionally, she has had hemorrhagic petechiae in the skin all over her body. Aplastic anemia was diagnosed based on the results of bone marrow biopsy. Epstein-Barr virus was detected and believed to be a cause of bone marrow anaplasia. She was placed on high doses of prednizone (350 mg daily), neopal (200 mg daily), cyclosporine (200 mg daily), Neupogen, and erythropoietin. Her condition was steadily deteriorating regardless of this treatment. One year into taking probiotic glycopeptides Zl016 her CBC has normalized. The average dose was 20 mg per day. The blood CBC results are presented in the figure above. 


Clinical efects in cancer patients 

Results published in Medical Oncology showed the significant clinical effects of glycopeptides, namely a prototype of ZL015 that mimics a peptidoglycan stem glycopeptide. A total of 63 patients in the terminal stages of various cancers were involved in those studies. All patients had received conventional treatment with chemotherapy and radiation. All of them suffered from cachexia and their blood tests revealed a 3 to10 fold increase in LDH activity for all five LDH isoenzymes; the activity of liver enzymes was also increased. PGN stem glycopeptide was given to 44 patients orally at a dosage of 0.5-1.5 mg/kg daily; 19 patients received a placebo. LDH activity was decreased by 40% in all 21 subjects who were given 0.5-1.0 mg/kg glycopeptide daily. In addition, LDH activity was lowered by 70% in 23 patients who received a1.5 mg/kg glycopeptide dose daily. Correspondingly, a 10% increase in LDH activity was noticed in 19 patients who were given a placebo. GGT activity was reduced by 35% in all seven patients, whose GGT level was measured. A drastic reduction in the level of triglycerides was noticed in all patients, as well as the reduction of the cholesterol level. During the follow-up period, the overall clinical condition of all patients treated with PGN glycopeptide was improved. Nine patients who experienced nausea from tumor toxicity before treatment noted symptoms subsiding after treatments. These studies demonstrated for the first time that glucosaminyl muramyl peptides could be powerful apoptosis modulators and antioxidants.

Clinical Observations