Navigation Links
InteKrin Therapeutics Presents Positive Long Term INT131 Preclinical Cardiovascular Safety Data at the 45th Annual European Association for the Study of Diabetes Meeting
Date:9/30/2009

LOS ALTOS, Calif., Sept. 30 /PRNewswire/ -- InteKrin Therapeutics Inc. announced today positive results for INT131 in long term, high exposure preclinical safety studies. Data will be presented at the 45th Annual European Association for the Study of Diabetes Meeting in Vienna, Austria at 12:45 PM Thursday, October 1, 2009 by InteKrin Therapeutics' Chief Operating Officer, Linda Higgins, PhD, in a presentation "Chronic Cardiovascular Safety of INT131 Besylate, a Selective PPAR-gamma Modulator (SPPARM) in Rodents and Monkeys is Differentiated from TZD Full Agonists."

"Typical cardiovascular effects noted with PPAR-gamma full agonists in preclinical and clinical studies, such as weight gain, fluid retention, cardiac hypertrophy, and premature death were not observed in the 2-year studies in rats and mice, or in a 1-year study in cynomolgus monkeys even at the highest doses tested, which provided very high exposure multiples of the clinical exposure at efficacious doses," said Dr. Higgins. "Results are consistent with in vitro and in vivo studies and with clinical data demonstrating a SPPARM profile of INT131 having unique PPAR-gamma activating properties with minimal cardiovascular side effects."

"Chronic nonclinical safety studies of PPAR-gamma ligands have been highly predictive of clinical experience," noted Jeri El Hage, PhD, an expert in PPAR toxicology who served over 18 years in the Center for Drug Evaluation and Research (CDER) at the FDA. "INT131 displayed an unprecedented preclinical safety profile with no cardiac safety signals at exposure multiples far greater than other PPAR agonists tested to date."

The high cardiovascular safety margin validates the design of INT131 to minimize the safety and tolerability issues associated with full agonist PPAR-gamma agents while retaining the clinically proved anti-diabetic properties of PPAR-gamma. In addition, the 2-year rodent studies showed no evidence of carcinogenicity following lifetime exposure to INT131. These results are enabling for INT131 to initiate planned Phase 3 clinical studies.

INT131 is a next-generation insulin sensitizer that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. INT131 has been designed to provide a safer therapeutic tool for physicians and patients, which is complementary to available classes of medications, and allows for powerful glucose control and the opportunity for modification of the underlying disease. As a SPPARM, INT131 selectively modulates PPAR-gamma, and is ideally positioned to safely improve insulin resistance, addressing an important unmet medical need.

About InteKrin (www.InteKrin.com):

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin's business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.

SOURCE InteKrin Therapeutics Inc.


'/>"/>
SOURCE InteKrin Therapeutics Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. InteKrin Therapeutics Announces Initiation of Phase 2b Study in Type 2 Diabetes with INT131
2. InteKrin Therapeutics Announces Enrollment Completion of 360 Patient, 24 week Phase 2b Study
3. InteKrin Therapeutics to Present at the 2009 American Diabetes Association Annual Meeting
4. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
5. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
6. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
7. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
8. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
9. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
10. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
11. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... York , April 27, 2016 ... report titled, "Skincare Devices Market - Global Industry Analysis, ... According to the report, the global skincare devices market ... is anticipated to expand at a CAGR of 10.1% ... in 2023. Browse the full Skincare Devices Market ...
(Date:4/27/2016)... Shire plc (LSE: SHP, NASDAQ: ... Financial Officer, will present at the Deutsche Bank 41st Annual ... on Wednesday, May 04, 2016, 10:00 am EDT (15:00 BST). ... the Presentations and Webcasts section of Shire,s Investor website at ... be available on this same website for approximately 90 days. ...
(Date:4/27/2016)... , April 27, 2016 ... to reach USD 2.06 billion by 2022, according ... Inc. Increasing consumer awareness towards a healthy lifestyle ... next seven years.      (Logo: ... intake coupled with rising health treatment expenditure has ...
Breaking Medicine Technology:
(Date:4/30/2016)... ... ... of us, but there are things we can do to improve the odds of staying healthy ... more that there are simple, yet important steps that can be taken to maintain good health ... for her patients include;, , exercise , healthy diet ...
(Date:4/29/2016)... ... 29, 2016 , ... In an article published April 16th on ... Botox and lip injections, which she underwent in order to feel more at home ... Arts Festival. The article explains that Ms. Mirmelli’s situation is not unique; many plastic ...
(Date:4/29/2016)... ... ... Our bodies are bombarded daily by environmental and lifestyle factors that can ... to adopt a more healthful diet, but too many people think that food has ... and the creator of the Newport Beach Cleanse and 14-Day Eating Plan, disagrees whole-heartedly. ...
(Date:4/29/2016)... ... 2016 , ... The White House announced efforts yesterday to ... about their loan terms and accounts, and more protections for borrowers. The announcement ... private loans, has reached $1.3 trillion, with 43 million Americans holding student loans ...
(Date:4/29/2016)... Southlake, Texas (PRWEB) , ... April 29, 2016 , ... ... and neck pain, is proud to announce one of their physicians has been invited ... Osteopathic Family Physicians (Texas ACOFP) Family Practice Review conference on April 30, 2016. ...
Breaking Medicine News(10 mins):