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:6/24/2016)... 2016  Collagen Matrix, Inc., ("Collagen Matrix") the ... of collagen and mineral based medical devices for ... Bill Messer has joined the company as ... the growing portfolio of oral surgery, neurosurgery, orthopaedic ... joins the Collagen Matrix executive team as an ...
(Date:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
(Date:6/24/2016)... 24, 2016 Research and ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" report ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, ... Structural electronics involves electronic and/or electrical components ... replacing dumb structures such as vehicle bodies or ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... Conventional wisdom ... of success. In terms of the latter, setting the bar too high can result ... more than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... ... ... in a crisis. Her son James, eight, was out of control. Prone to extreme mood ... something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a ... children and say he was going to kill them. If we were driving on ...
(Date:6/24/2016)... ... 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited to ... Recovery® program to drive cancer patients to and from their cancer treatments. Comfort ... quality of life and ongoing independence. Getting to and from medical treatments is ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute ... Dr. Barry M. Weintraub as a prominent plastic surgeon and the network’s newest ... world, and the most handsome men, look naturally attractive. Plastic surgery should be ...
Breaking Medicine News(10 mins):