Navigation Links
FDA Accepts Investigational New Drug Application for ARI-3030MO; First in Man Clinical Trial to Begin During First Quarter of 2011
Date:3/21/2011

BOSTON, March 21, 2011 /PRNewswire/ -- Arisaph Pharmaceuticals, Inc., a privately held drug discovery biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's recently submitted Investigational New Drug (IND) application to evaluate ARI-3037MO in a phase I human clinical trial in healthy volunteers.  ARI-3037MO, a proprietary new chemical entity, is a once-daily, niacin analog being developed for the treatment of dyslipidemia. In preclinical pharmacology studies, the compound produced greater lipid responses than niacin in a relevant animal model of hyperlipidemia.  Additionally, ARI-3037MO showed an extremely favorable safety profile, including the absence of flushing, in non-clinical drug safety studies. The Company believes that an efficacious and well tolerated niacin analog will be more widely utilized than existing forms of niacin in treating hypercholesterolemia, a disorder that afflicts as many as 93 million Americans according to data published by the American Heart Association.(1)

(Logo: http://photos.prnewswire.com/prnh/20110321/NE69091LOGO)

"The FDA's acceptance of our IND is a major milestone for Arisaph, particularly considering that we developed the compound from lead selection to IND filing in about 9 months," said Christopher P. Kiritsy, President and Chief Executive Officer of Arisaph Pharmaceuticals.  "With ARI-3037MO, we have designed a once a day, structural analog of niacin that retains niacin's beneficial biological effects on lipids without producing the irritating side effect of flushing."    

As part of the IND submission, Arisaph completed comprehensive nonclinical drug safety studies, including 28-day toxicology studies in rats and dogs.  The results show that ARI-3037MO has a favorable safety pharmacology profile and a wide therapeutic index.  One of the major challenges with current forms of niacin is that they are d
'/>"/>

SOURCE Arisaph Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. NYSE Amex Accepts China Shenghuos Compliance Plan for Continued Listing
2. The European Medicines Agency Validates and Accepts Cell Therapeutics Marketing Authorization Application for Pixuvri™
3. The SCOOTER Store Accepts Medicare Contracts
4. FDA Accepts Aricept® Patch (Donepezil Transdermal System) NDA for Review
5. FDA Accepts Sanofi Pasteur File Submission for Novel Influenza Vaccine Delivered by Intradermal Microinjection
6. FDA Accepts Sanofi Pasteurs Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers
7. Talecris Biotherapeutics CEO Accepts 2010 Ernst & Young Entrepreneur Of The Year Award on Behalf of Employees and Patients
8. FDA Accepts Once Daily 23 mg Aricept(R) Extended Release NDA for Review
9. FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)
10. FDA Accepts Arno Therapeutics IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway
11. Food and Drug Administration Accepts Isolagens Biologics License Application for Full Review
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... July 11, 2014  Kindred Hospital Houston Northwest, ... the opening of its new outpatient wound healing ... to people with chronic, hard to heal wounds. ... lead to amputation, lower leg wounds related to ... closure, and traumatic injury wounds which are complex ...
(Date:7/11/2014)... 2014 Research and Markets ( http://www.researchandmarkets.com/research/tjlw9k/immunoprotein ... "Immunoprotein Diagnostic Testing Market - Forecasts to 2019: ... 6% and is expected to be valued at ... http://photos.prnewswire.com/prnh/20130307/600769 ... been segmented according to immunoprotein types which include ...
(Date:7/10/2014)... MUMBAI, India , July 11, 2014 /PRNewswire/ ... the treatment of cancer are being highlighted in ... Mumbai from 10-12 July, 2014.  Renowned ... meeting to share best practices and exchange knowledge ... more precise, accurate and efficient. ...
Breaking Medicine Technology:Kindred Hospital Houston Northwest, With Wound Care Specialists, Opens Outpatient Wound Healing And Hyperbaric Center 2Immunoprotein Diagnostic Testing Market - Forecasts to 2019: Expected to grow at the highest CAGR of 6% and is expected to be valued at USD 4,943.0 million 2Improving quality and access to advanced cancer care in India and South Asia 2Improving quality and access to advanced cancer care in India and South Asia 3Improving quality and access to advanced cancer care in India and South Asia 4Improving quality and access to advanced cancer care in India and South Asia 5
... used an electronic clinical system since its inception in 2009 ... technology with an enterprise clinical and financial solution from Prognosis ... out as a completely electronic hospital. But we realize that ... of our needs," says Jeremy Lyman, CFO at the 11-bed, ...
... IOD Incorporated™, a leading provider of integrated HIM ... announced its response to the Health and Human Services ... from October 1, 2013 to October 1, 2014. ... to HHS regulations published in 2009, the current ICD-9 ...
Cached Medicine Technology:Blue Mountain Hospital Selects Enterprise System from Prognosis HIS 2Blue Mountain Hospital Selects Enterprise System from Prognosis HIS 3IOD Incorporated Advises Healthcare Providers to Stay the Course in Preparation for ICD-10 2IOD Incorporated Advises Healthcare Providers to Stay the Course in Preparation for ICD-10 3
(Date:7/13/2014)... 13, 2014 Recently, 2014QuinceaneraDresses.com, the ... unveiled its new range of gorgeous Quinceanera ... the demand for elegant Quinceanera outfits is huge. ... items. All the company’s newly released dresses are ... are all elegant and vivid. , It ...
(Date:7/13/2014)... MyDressCity.com, one of the most popular suppliers of wedding ... new range of elegant Quinceanera dresses . What’s ... prices. Worldwide clients can enjoy this special offer before ... shop, there are plenty of beautiful dresses for sale, ... MyDressCity.com’s hot items are prom gowns, bridesmaid gowns, wedding ...
(Date:7/13/2014)... 13, 2014 Epidemiologists forecast an increase ... 6MM, from 8,062 diagnosed incident cases in 2013 to ... Growth Rate (AGR) of 4.35%, during the forecast period. ... of diagnosed incident cases of aGVHD in the 6MM, ... the lowest number of diagnosed incident cases of aGVHD, ...
(Date:7/13/2014)... July 13, 2014 A decreased ability to ... impairment and Alzheimer,s disease, while examinations of the ... protein associated with Alzheimer,s, in the brain, according ... today at the Alzheimer,s Association International Conference 2014 ... the studies, the decreased ability to identify odors ...
(Date:7/13/2014)... 13, 2014 Wright & Schulte LLC ... been scheduled in July of 2015, in U.S. District ... are in the discovery process in the South ... is presiding over the multidistrict litigation (MDL). The complaints ... of individuals who allege that they took the statin ...
Breaking Medicine News(10 mins):Health News:2014QuinceaneraDresses.com Releases Its New Quinceanera Dresses 2Health News:Cheap Elegant Quinceanera Dresses Unveiled by MyDressCity.com 2Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 2Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 3Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 4Health News:Smell and eye tests show potential to detect Alzheimer's early 2Health News:Smell and eye tests show potential to detect Alzheimer's early 3Health News:Smell and eye tests show potential to detect Alzheimer's early 4Health News:Smell and eye tests show potential to detect Alzheimer's early 5Health News:Smell and eye tests show potential to detect Alzheimer's early 6Health News:Smell and eye tests show potential to detect Alzheimer's early 7Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 2Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 3Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 4
... (SAN DIEGO, December 11, 2011) Asymptomatic patients ... of non-Hodgkin lymphoma, have traditionally been watched for ... treated with a combination of rituximab and chemotherapy ... have suggested a role for treatment of asymptomatic ...
... is the first to systematically review and analyze the literature ... findings show a 74 percent greater risk of overdose among ... reasons for the increased risk are biological and behavioral, but ... now available online in advance of print in the journal ...
... COLLEGE PARK, Md. - Over the past decade, attacks and ... the work of extremists from across the political spectrum - ... actors - says an analysis by the National Consortium for ... at the University of Maryland. The statistics underscore the ...
... Norwegian University of Life Sciences (UMB) and Forschungszentrum Jlich ... analyses of electrical activity in the brain. The method, ... and researchers to better interpret brain cell signals. In ... terms of interpreting for example EEG measurements, making diagnoses ...
... Dec. 10 (HealthDay News) -- Giving low-dose aspirin to patients ... the lungs could cut their odds of redeveloping the clots, ... venous thromboembolisms (VTEs). These can include both the leg clots ... lungs that can cause rapid pulse, shortness of breath, chest ...
... By Steven Reinberg HealthDay Reporter , ... recommended Thursday that several newer forms of oral contraceptives ... potentially fatal blood clots. The U.S. Food ... the new labels for oral contraceptives such as Bayer,s ...
Cached Medicine News:Health News:Study favors as-needed treatment over maintenance therapy for patients with follicular lymphoma 2Health News:Study favors as-needed treatment over maintenance therapy for patients with follicular lymphoma 3Health News:RI Hospital study analyzes link between HIV infection and overdose risk 2Health News:RI Hospital study analyzes link between HIV infection and overdose risk 3Health News:Growing US violent extremism by the numbers: UMD database 2Health News:Growing US violent extremism by the numbers: UMD database 3Health News:Tapping the brain orchestra 2Health News:Low-Dose Aspirin After Lung Clot Could Prevent Recurrence 2Health News:Low-Dose Aspirin After Lung Clot Could Prevent Recurrence 3Health News:FDA Advisers: Newer Forms of the 'Pill' Need Revised Warning Labels 2Health News:FDA Advisers: Newer Forms of the 'Pill' Need Revised Warning Labels 3
... the Anterior Segment The BD is optimized ... ophthalmologists specializing in the anterior segment. It is ... c-mount camera on the BD 900- may be ... in 10 and 16 X times- through the ...
... The system that makes it ... Molecular Biology Workstation is an automated ... known sequences, such as in the ... and Short Tandem Repeats (STRs) using ...
... an integrated filter made of pure ... filter provides protection against carryover and ... does not swell up as a ... then be recovered easily. In line ...
Optimized 180W Xenon lamp, low fan noise with reduced air turbulence, compact housing. Built for monitor applications and all endoscope dimensions. Ideal for video recording applications....
Medicine Products: