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Grace Therapeutics, Inc GRCE

Grace Therapeutics, Inc., formerly Acasti Pharma Inc., is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Its therapeutic pipeline consists of three clinical-stage drug candidates supported by an intellectual property portfolio of over 40 granted and pending patents in various jurisdictions. Its lead drug candidate, GTX-104, is a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients to address significant unmet medical needs. GTX-104 provides a convenient IV delivery of nimodipine in the intensive care unit, eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Its other pipeline drug candidates include GTX-102, which is an oral-mucosal betamethasone spray for the treatment of Ataxia Telangiectasia and GTX-101, which is a topical bio adhesive film-forming bupivacaine spray for Postherpetic Neuralgia.


NDAQ:GRCE - Post by User

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Post by Francine01on Jan 23, 2018 1:53pm
229 Views
Post# 27417470

Amarin REDUCE-IT

Amarin REDUCE-ITIf Amarin REDUCE-iT is positive it will increase by 10x Acasti market.

We will have the answer before september end. :) :)

Amarin’s REDUCE-IT Cardiovascular Outcomes Study Reaches 90% Mark for Reported Primary Events

On Track for Patient Final Study Visits to Commence in March 2018

BEDMINSTER, N.J. and DUBLIN, Ireland, Jan. 23, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced that its REDUCE-IT cardiovascular outcomes study has reported and documented more than 90% of the targeted 1,612 primary major adverse cardiovascular events (MACE).  The vast majority of these events have been confirmed (i.e., positively adjudicated as a patient’s first on-study primary event) with some unable to be fully adjudicated per study protocol until after completion of the associated patients’ final study visits.  For this first of its kind, potentially landmark, REDUCE-IT cardiovascular outcomes study, Amarin confirmed that it is on track for onset of the targeted 1,612th event to occur before the end of Q1 2018. Patients are being scheduled for final study visits commencing March 1, 2018. Amarin maintains its guidance to report top-line results from the study before the end of Q3 2018.

"We are pleased to be nearing conclusion of this important study," commented Dr. Steven Ketchum, Amarin senior vice president, president of R&D, and chief scientific officer.  "The timing of accumulated events in this study and the scheduling of final patient visits are two important steps towards learning the results of this study and understanding the extent to which Vascepa and the REDUCE-IT trial results can lead to better informed preventative care of patients at high cardiovascular risk."   

Amarin is intentionally blinded to the results of the study and will remain blinded to such results until after the study is completed and the database is locked. Final patient visits will be followed by adjudication of newly reported cardiovascular events in the study, completing data entry for the greater than 33,000 patient years of study in REDUCE-IT, and typical database quality control measures, known as cleaning.  This will be followed by the database lock and final efficacy and safety analyses, including analysis of the trial's primary endpoint of first MACE events in the study, and the analyses of more than thirty pre-defined secondary and tertiary endpoints. Publication of the study design can be found at https://doi.org/10.1002/clc.22692.  The lead author of this paper published in Clinical Cardiology is Deepak L. Bhatt, M.D., M.P.H., executive director of the Interventional Cardiovascular Programs at Brigham and Women's Hospital, professor of medicine, Harvard Medical School in Boston, Mass.


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