Inhibikase Therapeutics, Inc. has just launched an observational clinical study of patients with a history of Progressive Multifocal Leukoencephalopathy (PML), an uncommon but highly fatal infection of the brain that has been linked as an adverse effect of some medications for autoimmune diseases, such as multiple sclerosis, blood and lymph cancers, and inflammatory bowel diseases (IBD). These medications can render patients to be immunocompromised, giving the John Cunningham virus (JCV) enough potency to cause a serious infection. Hence, this infection is also seen in patients with HIV/AIDS.
“The study intends to establish a link between the Company’s proprietary measures of JCV viral load and PML cases,” said Inhibikase CEO Dr. Milton Werner. “PML is induced by medications that mobilize a virus, JCV, to escape from its reservoir in the kidney and migrate into the brain. Once in the brain, JCV causes irreversible damage, often leading to death. The Company has a robust method for measurement of viral load in living patients. We now wish to measure the relationship between JCV viral load and JCV antibody titer in patients who survived the acute phase of the infection. PML survivors are a treasure trove of information that can help us to better understand the natural history and clinical virology of the disease. This is an important lead-up to the advancement of the Company’s lead antiviral, IKT-001Pro, into clinical development, which initiates in the 3rd or 4th quarter of 2015.”
“Because PML is such a rare disease, patients who survive the acute phase of the infection are very difficult to identify,” noted Dr. Werner. “Only a few hundred such patients reside in the U.S. or Europe, so the Company sought and received approval from its Advisory Board, as well as a national Institutional Review Board (IRB), to reach out to patients directly through the online, social and print media. To date, 12 such patients have contacted the Company to learn about the study.”
In other recent IBD-related news, children suffering from inflammatory bowel disease (IBD) who are reacting positively to prescribed biological medications should not have their prescriptions changed to recently approved “biosimilar” products, according to the results of an expert consensus statement issued by the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). These conclusions were published by Wolters Kluwer in the Journal of Pediatric Gastroenterology and Nutrition, which is the official journal of the European Society of Pediatric Gatroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.
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