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Past News Items - December 2011

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In the News

Compounding Pharmacy Prescription Dynamics to Launch in Montvale, NJ

Meta-Analysis Concludes Cinnamon and Cinnamon Extract Lowers Blood Glucose in People with Type 2 Diabetes or Prediabetes

SweetSpot Diabetes Care Receives FDA 510(k) Clearance for SweetSpot Diabetes Data Management Service

Approaching Alzheimer’s From Different Angles

Released: 12/01/11

Compounding Pharmacy Prescription Dynamics to Launch in Montvale, NJ

Research Partnership with Farleigh Dickinson University Will Enable Clinical Advances 

Michael De Giglio, CEO of Prescription Dynamics, today announced the December 1 opening of a state-of-the-art compounding pharmacy including sterile and non-sterile ISO 4 clean rooms and a shipping and fulfillment facility that will enable the delivery of prescriptions throughout the country. The firm’s research partnership with Fairleigh Dickinson University’s Medco School of Pharmacy will allow the pharmacy to provide its patients with the latest clinical advances.

Prescription Dynamics will provide compounded medications across a broad spectrum of medical specialties including medications for autism, dermatology, hormone replacement therapy, urology, and for veterinary needs.

“At a time when compounding is on the rise because of increasingly prevalent drug shortages, patient allergies, and the need for a particular dosage and strength that is commercially unavailable, we believe Prescription Dynamics will fill an important need not only in the Tri-State area but across the country,” said CEO Michael De Giglio. “Our partnership with Fairleigh Dickinson University (FDU) will provide our pharmacy with a research focus that will enable us to better serve our patients and our hospital and surgi-center partners.”

“I am looking forward to the partnership with Prescription Dynamics,” said Ruth E. Nemire, Dean of FDU’s Medco School of Pharmacy. “The community and future pharmacists will benefit in many ways.”

Meta-Analysis Concludes Cinnamon and Cinnamon Extract Lowers Blood Glucose in People with Type 2 Diabetes or Prediabetes

A new Meta-Analysis of eight human clinical trials examining the effect of cinnamon consumption in people with Type 2 diabetes and/or prediabetes concluded cinnamon extract and/or cinnamon lowers blood glucose in people with type 2 diabetes or prediabetes.

Published in the Journal of Medicinal Foods, the study "Cinnamon Intake Lowers Fasting Blood Glucose: Meta-Analysis" was conducted by Paul A. Davis, Department of Nutrition, University of California–Davis, and Wallace H. Yokoyama, Western Regional Research Center, US Department of Agriculture.

When isolating those studies using only cinnamon extract the researchers found that "a significant overall effect on blood glucose levels" was retained.  "The fact that water extracts of cinnamon have (bioactive) activity suggests that these may be preferable in terms of use compared with whole cinnamon," they said.

"Using water extracts of cinnamon achieves the desired blood glucose effects while avoiding the nonpolar constituents in whole cinnamon or the cinnamon flavor components that have been linked to deleterious effects (e.g., oral lesions and mutagenicity)," they added.

Aqueous cinnamon extraction, which uses only cinnamon, water, heat and pressure, creates concentrated levels of specific procyanidins believed to be the active ingredients in promoting healthy glucose levels. 

The researchers also noted that consumption of "high doses of Cinnamomum cassia have raised concern due to the presence of coumarin," a naturally occurring compound in cinnamon.  "Coumarin is poorly soluble in water," they noted, and other researchers have shown that the water extract contains very low levels of coumarin.

Diabetes is the 7th leading cause of death in the United States. While the medical cost of diabetes and prediabetes in 2010 averaged $194 billion, the rising numbers of Americans with diabetes and prediabetes is expected to drive healthcare costs to $500 billion by 2020.

Davis and Yokoyama said that with 300 million people affected by diabetes globally, "the epidemic of type 2 diabetes worldwide has resulted in a pressing need to explore low-cost therapeutic approaches that reduce diabetes risk."

CinSulin was the cinnamon extract used in three of the four studies evaluated in the meta-analysis.

Information about CinSulin may be found at www.cinsulin.com.

SweetSpot Diabetes Care Receives FDA 510(k) Clearance for SweetSpot Diabetes Data Management Service

SweetSpot Diabetes Care, Inc. announced today it has received 510(k) clearance from the United States Food & Drug Administration (FDA) for the SweetSpot Diabetes Data Management Service which helps health care providers and patients see, understand and use blood glucose meter data to diagnose and manage diabetes.

"We spoke to many patients and health care providers to develop this service," said Christopher Logan, Chief Executive Officer of SweetSpot Diabetes Care, Inc. "Patients want something that works with all their devices that's as easy as an ATM. Health care providers want technology sophisticated enough that it's almost invisible—reports show up where and when they are needed and the data flow is fully automated. With the SweetSpot Diabetes Data Management Service more clinics will gain the benefit of comprehensive analysis of patient blood glucose data. We are thrilled to be cleared to market this to clinics."

The SweetSpot Diabetes Data Management Service automates the workflow of blood glucose data from device retrieval through data processing, analysis, report generation and delivery into clinical settings and electronic records. A cloud-based platform is the backbone—enabling secure interactions with all formats of patient devices and communications with all sites in the evolving diabetes care setting landscape.

Vendor-Neutral Device Retrieval Data from most common blood glucose meters can be retrieved during a step-by-step session at a physical kiosk or through a web-based application. Patient information and clinical history may be collected at the same time. For patients with multiple glucometers, data from all devices will be merged into one set.

Backend Processing and Analytics The SweetSpot Diabetes Data Management Service performs multiple data processing steps—checking the validity and completeness of data from devices. Various analyses are run when data is saved or updated within the system including time-series statistical analysis and pattern-recognition. Cohort analysis is also undertaken, looking at groupings and relationships such as gender, age, diabetes type, etc.

Immediate Report Generation and Delivery As soon as patient glucose data is retrieved, the SweetSpot Diabetes Data Management Service generates a report and pushes it straight to clinic printers and/or electronic health record systems. Patients can also receive reports via a secure link.

Comprehensive Visualizations of Critical Data Reports contain visualizations of daily and weekly glucose levels; display testing frequency; and provide statistical summaries and measures of glucose variability.
Reports may also compare a patient's data with their cohort and can be customized by a clinic to best support their providers and patients.

"Blood glucose data is important for effective diabetes management," said Adam Greene, SweetSpot Founder and Chief Technology Officer. "We are excited to offer a service that makes it practical for any clinic to access their patients' data and use that information to improve care."

For more information, go to http://www.sweetspotdiabetes.com

Approaching Alzheimer’s From Different Angles

Multitarget medication based on low doses of natural substances prove to positively influence Alzheimer’s. This information was presented at the Neuroscience convention last week.

Scientists from the John Hopkins University in Baltimore (USA) have estimated there were 26.6 million cases of Alzheimer’s disease worldwide in 2006. By 2050, they expect this number to quadruple. 1 in 85 persons will then be affected and in need of care, making Alzheimer’s one of the most costly diseases for society.

However, no preventive or curative therapy is available today. The few drugs that have been approved by regulatory agencies offer only a small symptomatic benefit. “Alzheimer’s is a multi-factorial disease. This calls for a change in the therapeutic paradigm towards a multitarget approach”, says Dr. Bernd Seilheimer, Head of Bioregulatory Development at Biologische Heilmittel Heel GmbH in Baden-Baden (Germany).
The benefit of a multitarget approach has now been demonstrated in preclinical studies. Hereby a medication was tested that is based on a combination of several natural substances in low doses. Initial studies using the electroencephalogram (EEG) as an approved standard method in medical diagnostics indicated strong effects on cognitive functions.

The gene clusters (in vivo) affected by the medication were identified at the St. Laurent Institute in Cambridge, MA (USA) using “Next Generation” genomics on the Helicos Genetic Analysis Platform. Based on these results, the effect on the processing of amyloid precursor protein (sAPP? and sAPP?), as well as neuronal growth and synaptic levels was determined at the University Hospital of Ulm (Germany) using molecular biological techniques.

“We are fascinated by the results“, says Dr. Bernd Seilheimer from Heel. “This homeopathically prepared medication leads to significant changes in the gene networks associated with synaptic function and plasticity. It significantly reduces the gene expression of APP and BACE, responsible for the formation of ?-amyloid plaques which hallmark Alzheimer’s disease. Upon treatment, axons of neurons even grew faster and longer than under saline control conditions.”



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