Inhibikase Therapeutics, Inc. announces the launch of an observational clinical study in patients who contracted Progressive Multifocal Leukoencephalopathy (PML), the rare and often fatal brain infection that arises as an unintended side effect of some medications used for treatment of Multiple Sclerosis, Crohn's disease, Ulcerative Colitis and certain cancers of the blood and lymph. PML also arises 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.
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