NetworkNewsBreaks – Lexaria Bioscience Corp. (NA
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Posted On: 03/01/2024 3:36:31 PM
NetworkNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Cleared to Commence HYPER-H23-1 Clinical Trial
Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug delivery platforms, today announced that the U.S. Food and Drug Administration (“FDA”) has confirmed the effectiveness of the company’s investigational new drug (“IND”) application thereby clearing Lexaria to conduct its planned U.S. Phase 1b hypertension clinical trial HYPER-H23-1 utilizing DehydraTECH-CBD. According to the announcement, the company is pleased to have complied with the FDA’s rules and procedures for clearance to perform this important registrational trial. The company will further announce when it is ready to begin the study, subject to certain conditions, including raising sufficient funding. “This is a significant milestone achievement for Lexaria demonstrating, for the first time, that its DehydraTECH technology meets the FDA’s high level of regulatory scrutiny sufficient to formally commence U.S. registrational clinical testing towards possible future pharmaceutical commercialization,” said John Docherty, president of Lexaria. “We look forward to commencing this important clinical trial and building upon the wealth of early stage clinical data we have gathered and presented to the FDA to date demonstrating the safety, efficacy and novel mechanistic performance of DehydraTECH-CBD in hypertensive patients.”
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://nnw.fm/LEXX
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
Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug delivery platforms, today announced that the U.S. Food and Drug Administration (“FDA”) has confirmed the effectiveness of the company’s investigational new drug (“IND”) application thereby clearing Lexaria to conduct its planned U.S. Phase 1b hypertension clinical trial HYPER-H23-1 utilizing DehydraTECH-CBD. According to the announcement, the company is pleased to have complied with the FDA’s rules and procedures for clearance to perform this important registrational trial. The company will further announce when it is ready to begin the study, subject to certain conditions, including raising sufficient funding. “This is a significant milestone achievement for Lexaria demonstrating, for the first time, that its DehydraTECH technology meets the FDA’s high level of regulatory scrutiny sufficient to formally commence U.S. registrational clinical testing towards possible future pharmaceutical commercialization,” said John Docherty, president of Lexaria. “We look forward to commencing this important clinical trial and building upon the wealth of early stage clinical data we have gathered and presented to the FDA to date demonstrating the safety, efficacy and novel mechanistic performance of DehydraTECH-CBD in hypertensive patients.”
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://nnw.fm/LEXX
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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