NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) An
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Posted On: 10/05/2023 3:58:35 PM
NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces $45.1M NINDS Grant to Support Expanded Access Protocol for CNM-Au8(R) in ALS
Clene (NASDAQ: CLNN), through its wholly owned subsidiary Clene Nanomedicine Inc. in collaboration with Columbia University and Synapticure, was awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (“NINDS”), a division of the National Institutes of Health (“NIH”). The grant is to support an Expanded Access Protocol (“EAP”) for the company’s investigational drug, CNM-Au8(R), in amyotrophic lateral sclerosis (“ALS”). Also referred to as Compassionate Use, an EAP is an FDA-regulated pathway that allows people with a serious and life-threatening disease to access an investigational drug that is not yet approved by the U.S. Food and Drug Administration (“FDA”). “This EAP study will give ALS patients who don’t meet the criteria to enroll in a clinical trial an opportunity to try CNM-Au8 as a novel investigational therapy through this EAP program,” said Jinsy A. Andrews, M.D., MSc, FAAN, an associate professor of neurology in the Division of Neuromuscular Medicine and director of Neuromuscular Clinical Trials at Columbia University Vagelos College of Physicians and Surgeons. “Programs like this help to advance research and much-needed innovation in ALS.”
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Clene (NASDAQ: CLNN), through its wholly owned subsidiary Clene Nanomedicine Inc. in collaboration with Columbia University and Synapticure, was awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (“NINDS”), a division of the National Institutes of Health (“NIH”). The grant is to support an Expanded Access Protocol (“EAP”) for the company’s investigational drug, CNM-Au8(R), in amyotrophic lateral sclerosis (“ALS”). Also referred to as Compassionate Use, an EAP is an FDA-regulated pathway that allows people with a serious and life-threatening disease to access an investigational drug that is not yet approved by the U.S. Food and Drug Administration (“FDA”). “This EAP study will give ALS patients who don’t meet the criteria to enroll in a clinical trial an opportunity to try CNM-Au8 as a novel investigational therapy through this EAP program,” said Jinsy A. Andrews, M.D., MSc, FAAN, an associate professor of neurology in the Division of Neuromuscular Medicine and director of Neuromuscular Clinical Trials at Columbia University Vagelos College of Physicians and Surgeons. “Programs like this help to advance research and much-needed innovation in ALS.”
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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