Data Also Support Drug's Efficacy at Improving Glycemic Control and

Reducing Diabetic Cardiovascular Complications

    CHICAGO, Ill., June 23 /PRNewswire/ -- VeroScience, LLC, in conjunction
 with its commercialization partner S2 Therapeutics, Inc., reported today
 the results of its Phase IIIb clinical trial supporting the overall and
 cardiovascular safety of Cycloset(TM) (A quick release formulation of
 bromocriptine mesylate) in subjects with type 2 diabetes. The study, which
 highlighted a significant reduction in the risk of diabetic cardiovascular
 complications in subjects treated with Cycloset(TM) compared to placebo,
 also confirmed the drug's ability to improve glycemic control in subjects
 failing metformin plus sulfonylurea therapy.
     The data were presented by the principle investigator, J. Michael
 Gaziano, MD, MPH, Cardiologist at Brigham and Women's Hospital and Veteran
 Affairs Boston Healthcare System, Boston, MA as a late-breaking poster at
 the 67th Scientific Sessions of the American Diabetes Association in
 Chicago, Ill. (June 22-26, 2007).
     Cycloset(TM) is being investigated as a once-daily, timed oral therapy
 for type 2 diabetes that acts upon the central nervous system (CNS) to
 impact peripheral metabolism. The Phase IIIb trial was conducted in
 response to an approvable letter from the FDA requesting additional data on
 Cycloset(TM)'s cardiovascular safety.
     The double-blind, multi-center trial's 3,070 participants included
 subjects with type 2 diabetes between the ages of 30 and 80 with HbA1c less
 than or equal to 10.0 and BMI less than or equal to 43. Participants
 randomized into the study were all on a treatment regimen for their
 diabetes, which could include either diet alone, up to two oral
 hypoglycemic agents, insulin alone, or insulin with no more than one oral
 agent. Participants were randomized in a 2:1 ratio to Cycloset(TM) (2,054
 subjects; titrated from 1.6 mg/day to a maximum tolerated dose of up to 4.8
 mg/day) or placebo (1,016 subjects) and followed for 52 weeks. Primary and
 secondary endpoints were time to first all cause serious adverse event
 (SAE) and cardiovascular SAE, respectively; all SAEs were adjudicated by an
 independent review committee.
     "This cohort was selected to provide a real-world view of the safety of
 Cycloset(TM) in a group of patients with diabetes receiving a wide variety
 of diabetes regimens," said J. Michael Gaziano, MD, MPH. "We were
 particularly interested in assessing the potential of a cardiovascular
 benefit and we were excited to see that in this population and in a
 relatively short time period there were indications of a reduction in
 cardiovascular events among those treated with Cycloset(TM) compared to
 placebo."
     The rate of any serious adverse event was similar between Cycloset(TM)
 subjects (8.6%) and placebo subjects (9.6%). Furthermore, fewer subjects
 experienced a cardiovascular endpoint in the Cycloset(TM) arm (31 out of
 2,054; 1.5%) compared to the placebo arm (31 out of 1,016; 3.0%). Results
 of the Cox regression revealed a 43% reduction in the cardiovascular
 endpoint, pre-specified as the composite of myocardial infarction, stroke,
 and hospitalization for either angina, congestive heart failure, or
 coronary revascularization surgery events (hazard ratio 0.57 and 95%
 confidence interval of 0.34 - 0.93; P = 0.025). The most frequently
 observed non-serious adverse events included nausea, dizziness, and
 fatigue.
     Participants on a combined therapy of metformin and sulfonylurea with a
 baseline HbA1c greater than or equal to 7.5, indicating suboptimal glycemic
 control (mean baseline HbA1c of 8.3), were subjected to a pre-specified
 secondary analysis focused on Cycloset(TM)'s ability to reduce HbA1c after
 24 weeks of therapy. Those receiving Cycloset(TM) and completing 24 weeks
 of therapy (121 subjects) experienced a mean HbA1c reduction of 0.69 (P =
 0.0002) compared to respective placebo (71 subjects) and a mean HbA1c
 reduction from baseline of 0.67. Moreover 39% of these Cycloset(TM)
 subjects, versus 11% of these placebo subjects, reached the American
 Diabetes Association target goal of an HbA1c level of 7.0 (P = 0.0004).
     "Several decades of preclinical and clinical research have focused on
 investigating circadian neuroendocrine regulation of metabolism,
 particularly in relation to metabolic disease states such as obesity,
 metabolic syndrome and type 2 diabetes," said Anthony H. Cincotta, PhD,
 President and Chief Scientific Officer of VeroScience, LLC and a developer
 of Cycloset(TM) and its platform technology along with Dr. Albert H. Meier.
 "These study data build on our earlier investigations that suggested a
 beneficial impact of timed bromocriptine administration on cardiovascular
 risk factors apart from its influence on fasting glucose level."
     "With the favorable conclusion of this large one year safety study and
 additional information from other clinical studies, VeroScience intends to
 file an amended NDA with the FDA targeting late third or fourth quarter of
 2007," according to Richard E. Scranton, MD, MPH, Chief Medical Officer,
 VeroScience and co-principle investigator of the Cycloset(TM) Safety Trial.
     Charles P. Sutphin, Co-chairman and CEO of S2 Therapeutics, Inc.,
 holder of an exclusive global license for the manufacture, marketing, and
 distribution of Cycloset(TM), stated that "the commercial opportunity for
 Cycloset(TM) has dramatically expanded with the outcome of this trial. As a
 result, we are exploring strategies for Cycloset(TM)'s commercialization
 opportunities both within North America and globally by partnering with a
 large multinational pharmaceutical company."
     Data presented at the 67th Scientific Sessions of the American Diabetes
 Association during the Clinical Therapeutics/New Technology - Pharmacologic
 Treatment of Diabetes or its Complications and displayed Saturday, Sunday
 and Monday, June 23-25, in the General Poster Session: Poster # 50-LB,
 Effects of Timed Cycloset(TM) (A Quick Release Formulation of Bromocriptine
 Mesylate) Administration on Safety, Cardiovascular Event Rate, and Glycemic
 Control in Subjects with Type 2 Diabetes Receiving Diet, Oral Hypoglycemic,
 and/or Insulin Treatment Regimens. JM Gaziano, M Ezrokhi, AH Cincotta, RE
 Scranton.
     About Cycloset(TM) (A Quick Release Formulation of Bromocriptine
 Mesylate)
     Cycloset(TM) is an oral, quick-release formulation of bromocriptine, a
 centrally-acting dopamine D2 receptor agonist. When given as a single timed
 (morning) daily dose, Cycloset(TM) is believed to act on circadian neuronal
 activities within the hypothalamus to reset abnormally elevated
 hypothalamic drive for increased plasma glucose, triglyceride, and free
 fatty acid levels in fasting and postprandial states in insulin resistant
 subjects. Results of published clinical studies suggest that treatment with
 Cycloset(TM) may improve hyperglycemia, glucose intolerance,
 hyperlipidemia, or aspects of insulin resistance, while maintaining body
 fat neutrality or inducing body fat reduction.
     Cycloset(TM) is currently under investigation as a potential therapy
 for type 2 diabetes and has been studied in several Phase II and three
 Phase III studies. An NDA for the drug's use in the treatment of type 2
 diabetes has received an approvable letter from the FDA detailing the
 remaining data required for approval, primarily a large, simple safety
 trial. VeroScience anticipates filing an amended Cycloset(TM) NDA (a
 complete response to the approvable letter) in the late third or fourth
 quarter of 2007.
     About VeroScience, LLC
     VeroScience is a privately held biotechnology and healthcare product
 development company with main offices and laboratories in Tiverton, RI.
 VeroScience has a large patent portfolio that supports its preclinical and
 clinical development programs and product pipeline in the areas of
 metabolism, immunology, reproduction, and oncology. VeroScience leverages
 its intellectual property and products in out-licensing and collaborative
 arrangements with appropriate industry partners.
     About S2 Therapeutics, Inc.
     S2 Therapeutics is a specialty pharmaceutical organization,
 headquartered in Bristol, TN. S2 is the capital and commercialization
 partner for Cycloset(TM) and is holder of the exclusive global license for
 the manufacture, marketing and distribution of Cycloset(TM). S2 seeks
 opportunities in the pharmaceutical industry through in-licensing
 arrangements, acquisitions of novel branded prescription pharmaceutical
 products, and investing in development compounds and companies.
     Media Contact:
     Feinstein Kean Healthcare
     Christine Cramer
     617-761-6736
     Cell: 508-404-6522
     christine.cramer@fkhealth.com
 
 

SOURCE VeroScience, LLC

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