Navigation Links
FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
Date:3/11/2008

our scientists have designed into the compound, yielding a clinically differentiated product in this market."

"This important regulatory milestone enables Arisaph to begin the process of demonstrating the compound's promise in the clinic," commented Alexander "Zan" Fleming, M.D., clinical/regulatory consultant to Arisaph, President and Chief Executive Officer of Kinexum and former head of diabetes review at FDA. "As an endocrinologist, the unprecedented preclinical efficacy of ARI-2243 is very intriguing and the potential benefits for patients are very exciting. I look forward to working with Arisaph to demonstrate the differentiated efficacy and safety of ARI-2243 in the clinic."

As part of the IND submission, Arisaph completed comprehensive nonclinical safety pharmacology and toxicology studies, including 28 day toxicology studies in rats and primates. The results show that ARI-2243 has a favorable safety pharmacology profile and has a high therapeutic index. Based on the preclinical efficacy of ARI-2243, the company believes that low doses will produce superior blood glucose lowering compared with other DPP-4 inhibitors.

Arisaph designed ARI-2243 as a once a day, orally active, smart DPP-4 inhibitor that is highly potent and functionally selective. In vitro, kinetic studies show that ARI-2243 has an extremely high affinity (Ki of 27 picomolar) for the DPP-4 enzyme and drug dissociation from the enzyme is very slow. Such kinetics confer potency and long activity. During OGTT in normal mice, ARI- 2243 was 250 times more potent than sitagliptin and maximally lowered blood glucose by 88%. Additionally, in ZDF rats, an animal model that develops overt diabetes, ARI-2243 significantly reduced hemoglobin A1c (HbA1c) by 2.5% versus no effect with vildagliptin.(3)

In addition to the compelling preclinical efficacy, ARI-2243 is functionally selective through a smart, "soft drug" inactivation process. Specifically, ARI-2243 binds rapidly and tig
'/>"/>

SOURCE Arisaph Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
2. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
3. A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug Phenoxodiol
4. Ardea Biosciences, Inc. Announces Completion of Phase 1 Clinical Trials of Novel Investigational HIV Drug RDEA806
5. ECLIPSE Data on Effects of Otsukas Investigational Novel Treatment, Tolvaptan, on Advanced Heart Failure Patients Hemodynamics and Urine Output Featured in Heart Failure Society of Americas Late Breaking Trials
6. Replidynes Investigational Antibacterial Agent REP3123 Prevents Sporulation in Clostridium difficile
7. Replidynes Investigational Antibacterial Agent REP3123 Prevents Toxin Production in Clostridium difficile
8. Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Osteoporosis
9. Newly Published Phase II Study Shows the Investigational Drug Vandetanib Prolongs Progression-Free Survival in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
10. KineMed Presents Preclinical Data for Investigational Agent Demonstrating Neurogenesis and Confirming Improvements in Behavioral Model
11. Lexicon Reports Initial Clinical Trial Results for LX1031, an Investigational New Drug for Irritable Bowel Syndrome
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/30/2014)... 2014 Electrodes are devices that convert ... amplified to diagnose as well as treat several ... devices facilitate the detection of chemical reactions derived ... neurons of the patients. In addition, few electrodes ... current to perform minimally invasive surgical procedures. The ...
(Date:10/30/2014)... Oct. 29, 2014 CTI BioPharma Corp. (CTI) (NASDAQ ... months ended September 30, 2014. "During ... at the beginning of 2014 by securing a partner to ... expanding the market into countries where we do not have ... We believe this partnership will maximize the value of PIXUVRI ...
(Date:10/30/2014)... NEW YORK , Oct. 29, 2014 /PRNewswire/ ... strong growth through 2013 with the introduction of ... are well-covered in Vaccines: The World Market. The ... vaccines, covering specifically commercialized vaccines and developmental vaccines ... protects not only individuals, but also entire communities ...
Breaking Medicine Technology:Electrodes for Medical Devices Market (Diagnostic Electrodes - ECG, EEG, EMG, ERG and Fetal Scalp Electrodes, Therapeutic Electrodes - TENS, Pacemakers, Defibrillators, Electrosurgical and Other Electrodes) - Global Industry Analysis, Size, Share, G 2Electrodes for Medical Devices Market (Diagnostic Electrodes - ECG, EEG, EMG, ERG and Fetal Scalp Electrodes, Therapeutic Electrodes - TENS, Pacemakers, Defibrillators, Electrosurgical and Other Electrodes) - Global Industry Analysis, Size, Share, G 3Electrodes for Medical Devices Market (Diagnostic Electrodes - ECG, EEG, EMG, ERG and Fetal Scalp Electrodes, Therapeutic Electrodes - TENS, Pacemakers, Defibrillators, Electrosurgical and Other Electrodes) - Global Industry Analysis, Size, Share, G 4CTI BioPharma Reports Third Quarter 2014 Financial Results 2CTI BioPharma Reports Third Quarter 2014 Financial Results 3CTI BioPharma Reports Third Quarter 2014 Financial Results 4CTI BioPharma Reports Third Quarter 2014 Financial Results 5CTI BioPharma Reports Third Quarter 2014 Financial Results 6CTI BioPharma Reports Third Quarter 2014 Financial Results 7CTI BioPharma Reports Third Quarter 2014 Financial Results 8CTI BioPharma Reports Third Quarter 2014 Financial Results 9CTI BioPharma Reports Third Quarter 2014 Financial Results 10CTI BioPharma Reports Third Quarter 2014 Financial Results 11CTI BioPharma Reports Third Quarter 2014 Financial Results 12Vaccines 2014: World Market Analysis, Key Players, Trends, Pediatric and Adult Segments 2Vaccines 2014: World Market Analysis, Key Players, Trends, Pediatric and Adult Segments 3
... , , MOUNTAIN VIEW, Calif., Dec. 16 ... patients in a Phase 2 clinical trial of CCX354, an ... CCR1 chemokine receptor for the treatment of rheumatoid arthritis (RA). ... of CCR1, a chemokine receptor that drives the recruitment of ...
... , , ... - Studies Conducted at INRA-Agroparistech Laboratory Under Pr. Daniel,Tome,s Supervision ... International Bone and Mineral Society "Bone", Reveal new Benefits for,Peptan(TM) ... to consumer concerns regarding long-term bone health,Rousselot has carried out, ...
Cached Medicine Technology:ChemoCentryx Initiates Phase 2 Clinical Trial of CCX354 for the Treatment of Rheumatoid Arthritis 2ChemoCentryx Initiates Phase 2 Clinical Trial of CCX354 for the Treatment of Rheumatoid Arthritis 3ChemoCentryx Initiates Phase 2 Clinical Trial of CCX354 for the Treatment of Rheumatoid Arthritis 4ChemoCentryx Initiates Phase 2 Clinical Trial of CCX354 for the Treatment of Rheumatoid Arthritis 5Published in "Bone" Journal, Scientific Researches Confirm Peptan(TM) Hydrolyzed Collagen Benefits on Bone Health 2
(Date:10/30/2014)... CA (PRWEB) October 30, 2014 Graphics, ... terms are synonymous with the craft of web design ... functional website. Yet a simpler solution to create a ... Thus, pictures, videos, contact information, customer reviews and Facebook ... , "It is the next evolution of how ...
(Date:10/30/2014)... 30, 2014 High efficacy and ... in the medical-grade skin care domain: Cosmederm, the ... uniquely potent topical dermatological products, today announces the ... ) with patented COSMEDERM®-7 anti-irritant technology. , ... (50% and 70%) and a low pH (pH ...
(Date:10/30/2014)... 2014 PreDiabetes Centers , the ... shoppers with a supply of sugardown®, a chewable ... post-meal blood sugar spikes. Learning how to control blood ... part of a diabetes prevention plan. , Shoppers who ... complimentary tube of sugardown. The offer expires November 30. ...
(Date:10/30/2014)... 2014 Radio listeners who indicate use ... the impact of traditional radio commercials and have overwhelmingly ... to influence a purchasing decision. , Those are some ... conducted by radio marketing company CRN International. The research ... results of respondents who indicated they have purchased or ...
(Date:10/30/2014)... Tara Haelle HealthDay Reporter ... More than 100 genes have been identified that appear ... And researchers say they are on their way ... contribute to the disorder. Autism spectrum disorders include ... social difficulties and repetitive behaviors. An estimated one in ...
Breaking Medicine News(10 mins):Health News:Facebook Websites In Thirty-Seconds 2Health News:Cosmederm Redefines Peel Science Standard with Launch of Refinity® Skin Health System 2Health News:Cosmederm Redefines Peel Science Standard with Launch of Refinity® Skin Health System 3Health News:Cosmederm Redefines Peel Science Standard with Launch of Refinity® Skin Health System 4Health News:PreDiabetes Treatment Company Offers PreD Store Shoppers Supplements to Support Healthy Blood Sugar 2Health News:CRN Research On Radio Messaging Effectiveness Now Available In Four Specific Product Categories 2Health News:CRN Research On Radio Messaging Effectiveness Now Available In Four Specific Product Categories 3Health News:Discovery of 100-Plus Genes Tied to Autism May Improve Treatments 2Health News:Discovery of 100-Plus Genes Tied to Autism May Improve Treatments 3
... computed tomography (CT), magnetic resonance imaging and molecular imaging ... multi-modal contrast agent – Researchers // at the University ... these new agents may, in turn, significantly improve the ... a professor in the department of speech and hearing ...
... In the race for supremacy in the Indian biotech ... spot during the fiscal (2005-06) // by contributing ... (Rs.65 billion) as against 37 percent by the southern ... performance, Karnataka Biotech Vision group chairperson Kiran Mazumdar-Shaw told ...
... has been develooped to assess the risk of heart disease ... wrongly assessed. // ,ETHRISK is for everyday use ... has been developed by researchers at the University of Bristol ... British black and minority ethnic groups. ,Ethnic groups within Britain ...
... African union and aid organisations said on Wednesday, that, Africa ... years. // This is about three times as much as the ... pledge, in Beijing, made at a donors conference did not expect ... been reported in eight African countries since February, and this ...
... revealed that while the chances of surviving a heart attack ... unchanged. // ,The Canadian Institute for Health Information ... rate for people suffering a new heart attack fell to ... 1999-2000 whereas in the case of strokes, 18.8 per cent ...
... According to the recent report from the health authorities of central ... disease//. Statistics show that the disease is prevalent in the month ... ,The scenario was worse in 2002 were human deaths crossed 66. ... by the health authorities the number of deaths reduced to 12 ...
Cached Medicine News:Health News:New Multi-Modal Contrast Agents, A Boon For Medical Imaging 2Health News:New Multi-Modal Contrast Agents, A Boon For Medical Imaging 3Health News:New Multi-Modal Contrast Agents, A Boon For Medical Imaging 4Health News:Western Region Tops in Indian Biotech Growth 2Health News:New Web- Based Calculator to Assess Heart Disease Risk 2Health News:Survival Rates of Heart Attack Improving 2
... manual hemostasis analyzer that is ideal ... PTs, aPTTs, thrombins, fibrinogens and factor ... testing, this analyzer is small in ... time and labor saving benefits. Operation ...
... STart benchtop coagulation analyzers feature ... clot detection. This method eliminates ... other optically dense samples or ... and preprogrammed assays with curve ...
... Description,The STA-R Evolution is a fully-automated, ... the total laboratory automation line. Clotting, ... simultaneously in random access mode. The ... offers high throughput and rapid processing ...
The ACL 9000 together with an extensive test menu and superior technology is backed by high-quality service to keep the lab running efficiently....
Medicine Products: