OncologyVeroScience Presents Data On Newly FDA Approved Drug Cycloset At American Diabetes Association Annual Scientific Sessions
VeroScience, in collaboration with S2 Therapeutics, announced the presentation of clinical and preclinical data at the American Diabetes Association (ADA) 69th Scientific Sessions on Cycloset, a novel treatment for patients with Type 2 diabetes. FDA-approved in May 2009, Cycloset is the first therapy directly targeting the body"s dopamine activity to improve glycemic control. It is also the only drug to be approved subsequent to the FDA"s new guidelines that require studies demonstrating that diabetes drugs do not increase cardiovascular risk.
The data presented today reviewed the impact of adding Cycloset to the treatment regimen of patients with Type 2 diabetes who are failing thiazolidinedione (TZDs), as indicated by a baseline HbA1c of greater than or equal to 7.5 percent. The study found that patients taking Cycloset with TZDs demonstrated a statistically significant improvement after 52 weeks on therapy, compared to those taking TZDs (Rosiglitazone or Pioglitazone) with or without other oral anti-diabetes medications. The post-hoc study, from the Company"s 3,070-patient Cycloset Safety Trial, evaluated 79 patients failing TZD therapies at baseline.
The Cycloset with TZD treatment group demonstrated a 0.76 percent decrease in A1c compared to a 0.25 percent reduction in the placebo group (pPreclinical data presented at ADA
Two preclinical presentations further demonstrate how Cycloset impacts metabolism in hypertensive (high blood pressure) rat models.
The research studies entitled, "Sympatholytic dopamine agonist therapy reduces insulin resistance and protein levels of pro-inflammatory mediators in liver of SHR rats," and "Bromocriptine treatment improves insulin sensitivity, attenuates hepatic expression of multiple protein mediators within several inflammatory pathways that potentiate insulin resistance, and increases hepatic PGC-1 levels in SHR rats," show that the active agent in Cycloset leads to statistically significant reductions in plasma insulin, glucose and HOMA-IR, a common measure of insulin responsiveness, as well as significant reductions in modulators of liver and systemic inflammation, in an insulin-resistant animal model. Most importantly, according to the two studies, the active agent in Cycloset decreased the levels of liver pro-inflammatory pathway proteins that contribute to hepatic insulin resistance and also ultimately, potentiate cardiovascular disease risk. These findings add important new information to the growing body of data regarding Cycloset"s mechanism of action and its beneficial impact on glycemic control, and potentially, cardiovascular disease.
About Cycloset and the Biological Clock
Preclinical studies indicate that while an increase in dopamine activity leads to improvements in diabetes, the time of day of the increased dopamine activity is also important. Studies in diabetic animals have shown that increased dopaminergic activity at a particular time of day is most effective in "resetting" the biological clock neurochemistry to a physiology that improves diabetic dysmetabolism. Taken orally, once-a-day, in the morning, Cycloset provides a single brief pulse of dopamine agonist activity shortly after its administration. Morning Cycloset improves post-prandial (after-meal) glucose without increasing plasma insulin concentrations, and the beneficial effects of Cycloset on post-meal glycemic control in patients with Type 2 diabetes are demonstrable many hours after the drug has been substantially cleared from the circulation, for example at lunch and dinner.
Safety
The Cycloset Safety Trial, a 3,070 person, one-year study, demonstrated that Cycloset at doses up to 4.8 mg per day used to treat Type 2 diabetes was not different from placebo regarding the rate of occurrence of all-cause serious adverse events. None of the serious adverse events grouped by System Organ Class occurred more than 0.3 percentage points higher with Cycloset than with placebo. Additionally, Cycloset did not show an increase in pre-specified and independently adjudicated adverse cardiovascular outcomes-a composite of myocardial infarction, stroke, hospitalization for unstable angina, congestive heart failure and revascularization surgery-compared to patients taking a placebo (Hazard Ratio: 0.58; Confidence Interval: 0.35-0.96). Cycloset can cause hypotension, including orthostatic hypotension and syncope, particularly upon dose initiation or escalation. The primary reason for discontinuation from clinical trials of Cycloset was nausea, which was mild to moderate and transient during the beginning of therapy.
About VeroScience
VeroScience is a privately held biotechnology and healthcare product development company with main offices and laboratories in Tiverton, R.I. VeroScience holds the NDA and related intellectual property for Cycloset, an FDA approved treatment for patients with Type 2 diabetes. The Company has a large patent portfolio that supports its preclinical and clinical development programs and product pipeline in the areas of metabolism, immunology and oncology. VeroScience leverages its intellectual property and products in out-licensing and collaborative arrangements with appropriate industry partners.
S2 Therapeutics