$PTIE - FDA Has Cleared an Investigational New Dru
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Posted On: 07/31/2017 8:04:52 AM
$PTIE - FDA Has Cleared an Investigational New Drug (IND) Application for PTI-125
AUSTIN, Texas, July 31, 2017 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq
TIE), a biopharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PTI-125, a novel drug candidate to treat Alzheimer's Disease. As a result, clinical testing with PTI-125 will begin shortly, with funding provided by a $1.7 million research grant from the National Institutes of Health (NIH).
PTI-125 will initially be tested in a Phase I ‘first-in-human' study to observe measures of safety and pharmacokinetics and to inform dosing for future studies. The design of this Phase I study was based on FDA feedback, clinical and scientific rationale and observations from previously conducted preclinical and in vitro studies. Study results are expected by year-end 2017.
The Company's Phase I study with PTI-125 will be funded by a $1.7 million grant from the NIH. The NIH's National Institute on Aging awarded this research grant to Pain Therapeutics following a competitive, peer-reviewed evaluation of PTI-125 on scientific merit and clinical promise by a panel of academic, clinical and industry experts in Alzheimer's Disease and other neurological disorders. The underlying science for PTI-125 has been published in Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, PLOS-One and other peer-reviewed scientific journals.
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This comes on the recent announcement of NIH grant for research on the same, which certainly sheds light that this company can move in the upwards direction.
Still holding out for REMOXY results for the end of the year. Maybe we'll luck out and we'll have submission for REMOXY and PTI-125 study results both at the end of 2017?
AUSTIN, Texas, July 31, 2017 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq
TIE), a biopharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PTI-125, a novel drug candidate to treat Alzheimer's Disease. As a result, clinical testing with PTI-125 will begin shortly, with funding provided by a $1.7 million research grant from the National Institutes of Health (NIH). PTI-125 will initially be tested in a Phase I ‘first-in-human' study to observe measures of safety and pharmacokinetics and to inform dosing for future studies. The design of this Phase I study was based on FDA feedback, clinical and scientific rationale and observations from previously conducted preclinical and in vitro studies. Study results are expected by year-end 2017.
The Company's Phase I study with PTI-125 will be funded by a $1.7 million grant from the NIH. The NIH's National Institute on Aging awarded this research grant to Pain Therapeutics following a competitive, peer-reviewed evaluation of PTI-125 on scientific merit and clinical promise by a panel of academic, clinical and industry experts in Alzheimer's Disease and other neurological disorders. The underlying science for PTI-125 has been published in Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, PLOS-One and other peer-reviewed scientific journals.
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This comes on the recent announcement of NIH grant for research on the same, which certainly sheds light that this company can move in the upwards direction.
Still holding out for REMOXY results for the end of the year. Maybe we'll luck out and we'll have submission for REMOXY and PTI-125 study results both at the end of 2017?
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