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Polaryx gets all-clear to start clinical trials
May 2020
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PARAMUS, N.J.—Last month, Polaryx Therapeutics Inc. reported that it had received Investigational New Drug Application approval from the FDA to evaluate PLX-200 in patients with juvenile neuronal ceroid lipofuscinosis (JNCL or CLN3). JNCL is a rare, fatal lysosomal storage disorder caused by a mutation in the CLN3 gene. JNCL sufferers only live to age 30 at the most, and there are no drugs to halt disease progression.
 
“We are very excited about our CLN3 IND approval from the FDA, as we can go ahead with CLN3 clinical studies with PLX-200. We also recently received a CLN2 IND approval with PLX-200 from the FDA. Our team has made tremendous efforts to move forward in preparing clinical trials in order to start studies as soon as possible,” Dr. Hahn-Jun Lee, president and CEO of Polaryx Therapeutics, stated in a press release.

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