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Posted: June 9, 2012 at 11:12 pm
PHILADELPHIA, PA--(Marketwire -06/09/12)- Diartis Pharmaceuticals, Inc. today presented positive data from its recently completed Phase 1 multicenter clinical trial of VRS-859 (exenatide-XTEN) at the American Diabetes Association's 72nd Scientific Sessions, which began yesterday in Philadelphia. VRS-859, a long-acting glucagon-like peptide-1 (GLP-1) analog, is being developed as a once monthly treatment for patients with type 2 diabetes mellitus (T2DM). The Diartis poster -- "Safety, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Administration of VRS-859 in Patients with Type 2 Diabetes" -- was presented today, June 9, in the 11:30 am to 12:30 pm Clinical Therapeutics/NewTechnology session (Poster Presentation 1105-P).
Jeffrey L. Cleland, Ph.D., Diartis Chief Executive Officer, was present at the poster session to discuss the recently completed safety, pharmacokinetic (PK) and pharmacodynamics (PD) results from the company's Phase 1 clinical trial in T2DM patients. The Phase 1 multicenter, blinded, placebo-controlled, single-ascending dose study was designed to evaluate the safety and tolerability of VRS-859 as well as the ability to maintain glycemic control for one month in T2DM patients after a single dose.
"We are very encouraged by the robust results seen in this initial Phase 1 study, most notably the statistically significant reductions in HbA1c levels at 30 days after only a single 200 mg dose of VRS-859," commented Dr. Cleland. "We are also quite pleased by the dose-proportional decreases in body weight observed within 30 days after a single treatment."
The Phase 1 results in T2DM patients demonstrate that all doses administered (up to 200 mg) were well tolerated and no unexpected adverse events were noted. Furthermore, the PK of VRS-859 in these patients was dose linear and comparable to the profile predicted from preclinical studies, validating the half-life extension capability of the XTEN technology and supporting a once monthly dosing regimen for VRS-859.
The Phase 1 Trial The primary objective of the study was to determine the safety and tolerability of a single subcutaneous dose of VRS-859 in patients with T2DM. Secondary objectives included single dose pharmacokinetics, assessment to evaluate evidence of VRS-859 activity by measurement of fasting plasma glucose and response to oral glucose tolerance tests at selected times post-dose, as well as to evaluate post-challenge glucose excursions. Seventy T2DM patients concurrently on metformin were enrolled in the study: 18 patients received placebo and 52 patients received one of six dose levels: 12.5, 25, 50, 100, 150 and 200 mg.
The study demonstrated that a single dose of VRS-859 achieved very high plasma concentrations and provided statistically significant and persistent improvements in glycemic control. There were no reported SAEs in the study. Adverse events, including those related to GI tolerability, were primarily mild and transient. These results support the company's plan to conduct a 6-month repeat dose study to determine a safe and efficacious subcutaneous dose of VRS-859 in patients with T2DM. It is hoped that upon successful development of this compound, VRS-859 may allow T2DM patients to safely manage their glucose with a therapy that is superior to current treatments for diabetes.
About Diabetes TreatmentTreatment of diabetes involves lowering blood glucose levels. Despite the availability of current therapies, more than 60 percent of people with diabetes do not achieve their target levels with their current treatment regimen. In addition, approximately 80 percent of type 2 diabetes patients are either overweight or obese. After diagnosis, type 2 diabetes patients are often placed on a diet and exercise program to control blood glucose levels and reduce body weight, but these patients usually progress to oral drug therapy, metformin and/or sulfonylurea. However it has been demonstrated that many patients are still unable to achieve adequate glycemic control on diet and exercise plus these oral therapies.
About VRS-859The compound has been designed to provide improved therapeutic outcomes for T2DM patients including robust and sustained improvements in HbA1c, improved tolerability, prolonged half-life (up to monthly dosing), as well as enhanced administration of a liquid formulation via a fine-gauge needle. The development goal is to satisfy the unmet needs of T2DM patients as well as contribute to treatment of the worldwide healthcare problem of obesity.
About Diartis PharmaceuticalsDiartis Pharmaceuticals, Inc. is a privately held biopharmaceutical company with headquarters in Redwood City, CA. Diartis develops novel biologics with enhanced properties to provide improved therapeutic outcomes to patients with metabolic diseases. The company's initial focus is the development of a long-acting GLP-1 receptor agonist that conveniently delivers maximum glucose control, aids compliance and adherence via less frequent administrations, and has improved GI tolerability. Diartis acquired the VRS-859 (exenatide-XTEN) program from Versartis, Inc. and continues its development for T2DM.
XTEN is a novel hydrophilic sequence of natural amino acids and is expressed as a fusion protein with a therapeutically active peptide or protein. New compounds developed by Diartis using the XTEN technology are expected to provide improved therapeutic outcomes such as enhanced efficacy/compliance, fewer side effects, prolonged half-life (up to monthly dosing), as well as low-cost production and enhanced stability. Further information on Diartis can be found at http://www.diartispharma.com.
Posted: June 9, 2012 at 6:14 am
07-06-2012 11:56 (704) 412-8013 -- Call for more info or to attend our free workshop. Do you need to lose weight? Have you tried diets, and they don't work? Are you exercising and not seeing any results? Have you tried the same diets as your friends, but they didn't work for you? Have you had weight loss,...
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Sick of Diets? This Works Better! Free Workshop |704-412-8013|Charlotte|28213|28262|28269|NC - Video
Posted: June 9, 2012 at 6:14 am
07-06-2012 11:56 (704) 412-8013 -- Call for more info or to attend our free workshop. Do you need to lose weight? Have you tried diets, and they don't work? Are you exercising and not seeing any results? Have you tried the same diets as your friends, but they didn't work for you? Have you had weight loss,...
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Lose Weight With a Diet That Works - Free Workshop |704-412-8013|Charlotte|28213|28262|28269|NC - Video
Posted: June 9, 2012 at 6:14 am
07-06-2012 11:56 (704) 412-8013 -- Call for more info or to attend our free workshop. Do you need to lose weight? Have you tried diets, and they don't work? Are you exercising and not seeing any results? Have you tried the same diets as your friends, but they didn't work for you? Have you had weight loss,...
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This Dukan Diet Alternative Works-- Free Workshop|704-412-8013|Charlotte|28213|28262|28269|NC - Video
Posted: June 9, 2012 at 6:14 am
07-06-2012 11:56 (704) 412-8013 -- Call for more info or to attend our free workshop. Do you need to lose weight? Have you tried diets, and they don't work? Are you exercising and not seeing any results? Have you tried the same diets as your friends, but they didn't work for you? Have you had weight loss,...
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This Detox Diet Alternative Works-- Free Workshop|704-412-8013|Charlotte|28213|28262|28269|NC - Video
Posted: June 9, 2012 at 6:14 am
In late May, the organic baby formula maker Natures One announced a goal ofzero arsenic in its product. Good, you say. Great. Makes perfect sense. Or it would except for this question - why is a poison like arsenic, of all things, an issue in baby formula?
Read a little further in the Natures One press release, and youll find a direct link to the problem. The link goes to a February study, published in the Journal of Applied Chemistry, titled Arsenic Concentration and Speciation in Infant Formula and First Foods.
That study, I want to emphasize, found nothing panic worthy, nothing but very trace levels of arsenic in formula and baby food. But, still, as I wrote last week, arsenic can have health effects at a surprisingly low dose. Its no wonder that Natures One so determinedly wants none of it.
But there are other things to wonder about here. Such as - why does arsenic so inconveniently turn up in the food supply? And are public health officials doing anything to protect us in this regard? These are connected questions but Ill give you one heads up on the latter. In the United States, the Environmental Protection Agency sets a safety limit of ten parts per billion for arsenic in drinking water. But to the frustration of advocates and scientists - the Food and Drug Administration offers no safety standard for arsenic in food .
And that matters because study I cited is just one of many telling us that there is some risk here. The word speciation in that title refers to the type of arsenic. The basic division is between organic (a carbon-containing compound) and inorganic arsenic. Its a big division actually. Our bodies metabolize organic arsenic compounds efficiently and they are not particularly dangerous. Inorganic arsenic, by contrast, is notably dangerous. And its that more poisonous variation that turned up in the baby formulas and cereals.
And here, as they say, is where the story gets interesting.
The researchers of that study, based at Dartmouth University, identified rice as the primary source of inorganic arsenic. They found it (again, in very tiny amounts) in rice syrup used to sweeten baby formula, rice cereal, rice flour used in making crackers and cookies. This does not mean that rice is by by nature a poisonous plant. It isnt.
But both soil and groundwater can contain arsenic - as a naturally occurring element and as a residue from the use of arsenic-based pesticides. And , as the Dartmouth scientists noted, Although As (arsenic) is not readily taken up by crops or transported to the edible parts, a notable exception is riceThe magnitude of this uptake varies widely between cultivars but the ability to take up elevated concentrations of As (in comparison with other cereal crops) appears to be a trait found in the entire rice germplasm.
In other words, rice turns out to be outstandingly good at absorbing arsenic from the environment and storing it. One reason is that the plant is designed to easily absorb the mineral silicon which helps give rice grains their elegantly smooth structure. The crystalline structure of arsenic is just close enough that rice plants readily uptake arsenic as well. In fact, a toxic metal study, also from Dartmouth, describes rice as a natural arsenic accumulator.
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The Arsenic Diet
Posted: June 8, 2012 at 4:22 pm
07-06-2012 11:56 (704) 412-8013 -- Call for more info or to attend our free workshop. Do you need to lose weight? Have you tried diets, and they don't work? Are you exercising and not seeing any results? Have you tried the same diets as your friends, but they didn't work for you? Have you had weight loss,...
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This 1200 Calorie Diet Alternative Works-- Free Workshop|704-412-8013|Charlotte|28213|28262|28269|NC - Video
Posted: June 8, 2012 at 4:22 pm
07-06-2012 11:56 (704) 412-8013 -- Call for more info or to attend our free workshop. Do you need to lose weight? Have you tried diets, and they don't work? Are you exercising and not seeing any results? Have you tried the same diets as your friends, but they didn't work for you? Have you had weight loss,...
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What are the Best Diets That Work? -- Free Workshop|704-412-8013|Charlotte|28213|28262|28269|NC - Video
Posted: June 8, 2012 at 4:22 pm
07-06-2012 11:56 (704) 412-8013 -- Call for more info or to attend our free workshop. Do you need to lose weight? Have you tried diets, and they don't work? Are you exercising and not seeing any results? Have you tried the same diets as your friends, but they didn't work for you? Have you had weight loss,...
Posted: June 8, 2012 at 4:22 pm
07-06-2012 11:56 (704) 412-8013 -- Call for more info or to attend our free workshop. Do you need to lose weight? Have you tried diets, and they don't work? Are you exercising and not seeing any results? Have you tried the same diets as your friends, but they didn't work for you? Have you had weight loss,...
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This Grapefruit Diet Alternative Works-- Free Workshop|704-412-8013|Charlotte|28213|28262|28269|NC - Video
