Washington, DC — Cardiocore, a premier centralized cardiac testing lab, announced today that its Chief Medical Officer, Lawrence Satin, MD, FACC, presented an advanced method to manage heart rate changes’ effect on QT assessment at the 2nd DIA Cardiac Safety Workshop in Japan, in Tokyo, on September 6, 2011.

Dr. Satin’s presentation featured a high-level modification of the Holter Bin methodology that successfully distinguishes QT changes that are caused by non-dangerous heart rate variations from QT changes that are caused by potentially fatal ion channel blockade. This approach has proven has been accepted by global regulatory bodies, enabling a smooth clinical development process for drugs that would otherwise have been slowed by a false positive Thorough QT study.

In annual this meeting of PMDA regulators, academicians, Japanese pharmaceutical company representatives and clinical pharmacology professionals, Dr. Satin also participated in an expert panel discussing “How TQT Studies May be Made More Efficient?”

More details about this key industry conference may be accessed through Cardiocore’s web site at http://www.cardiocore.com/news/events.

Washington, DC — Cardiocore, a premier cardiac core lab, and Tiba Medical, a leading blood pressure monitoring technology provider, announced today their alliance delivering advanced blood pressure monitoring solutions for both cardiac safety and efficacy clinical trials. The partnership is highlighted this week in Cardiocore’s exhibit (booth #511) at the Drug Information Association’s 46th Annual Meeting, here in Washington, DC.

As part of the agreement, Cardiocore offers Tiba Medical’s Blood Pressure Electronic Data Capture (BP-EDC) solutions to sponsors and Clinical Research Organization (CRO) partners. These solutions comprise a best-of-breed family of ambulatory, office and home blood pressure monitoring devices – including Tiba Medical’s flagship Ambulo 2400 Ambulatory Blood Pressure Monitoring (ABPM) systems.

The solution supports investigative sites with rapid Internet data transmission and a secure web portal for data management and reporting. Validated and verified to stringent industry standards including the FDA’s 21 CFR Part 11 and Good Clinical Practices guidelines, the system is specifically designed to enable seamless acquisition, analysis and reporting of blood pressure data in global clinical trials.

Special features include real-time data verification that ensures each recording’s completeness prior to transmission, and advanced configuration settings that accommodate even the most complex recording schedules. The Ambulo 2400 also contains a unique actigraphy system. This technology continuously tracks patients’ movements, automatically categorizing blood pressure measurements as “awake” or “asleep”.” This innovation eliminates a key cause of false-positive ABPM results, and reduces sponsors’ dependence on patient diary data which are often unreliable.

“Blood pressure is now recognized as an important biomarker in the evaluation of cardiac risk,” said Cardiocore Chief Medical Officer, Lawrence Satin, MD, FACC. “Regulatory agencies are requiring a closer look at this biomarker within several therapeutic areas including diabetes, oncology and central nervous system. Addressing that need, we are pleased to partner with Tiba Medical, incorporating their top-quality technologies to help enable success in our clients’ clinical development programs.”

“Cardiocore’s scientific leadership and proven experience in managing trials from Phase I to Phase IV, make them an ideal partner to deploy our blood pressure monitoring platform,” said Tiba Medical President and Chief Executive Officer, Mr. Merat Bagha. He continued, “Cardiocore’s study management teams provide global provisioning, site support and blood pressure data management incorporated with their other centralized cardiac testing modalities such as electrocardiography (ECG) and echocardiography (ECHO).”

For additional information and to obtain a detailed proposal for an upcoming trial involving blood pressure data management services, contact a Cardiocore’s business development representative in the US, Europe or Asia respectively.

Washington, DC — Cardiocore, a premier centralized cardiac testing lab, announced today that its Senior Scientist, Nelson Schiller, MD, FACC, presented data regarding the value of echocardiography in anti-diabetic drug development at the American College of Cardiology’s 59th Annual Scientific Session (ACC.10), this week in Atlanta, Georgia.

Dr. Schiller’s scientific poster, Effect of the Dual Peroxisome Proliferator-Activated Receptor PPAR Alpha/Gamma Agonist, Muraglitazar, on Cardiac Structure and Function in Type 2 Diabetic Patients, describes a 555 patient, 87 site, global, Phase-III, sub-study that Cardiocore’s echocardiography (ECHO) experts performed for a Top Ten pharmaceutical company. Co-authors include Cardiocore Vice President of Medical Operations, Polina Voloshko, MD, Cardiocore Head of Echocardiography, Dean Alokozai, MD and UCSF cardiology fellow, Vijay Rao, MD, PhD.

The study’s objective was to investigate the influence of chronic exposure to the dual perixosome-proliferator activated receptor a/g agonist, muraglitazar, compared to glimepiride on cardiac structure and function in type 2 diabetic patients. Data points analyzed by the centralized ECHO core laboratory included left ventricular mass, mass index, ejection fraction, end-systolic volume and end-diastolic volume, following American Society of Echocardiography (ASE) guidelines.

“The results showed that centralized echocardiography may be used to collect valuable, actionable data regarding an anti-diabetic drug’s affect on cardiac function, within a rapid 6-to-12 month sub-study,” explained Dr. Voloshko. She noted, “This use of targeted ECHO testing offers great efficiency to drug developers as they consider implementation of much larger cardiac safety clinical trials per FDA recommendations.”

The FDA issued Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes in December, 2008. This publication recommends that anti-diabetic drug developers conduct late phase studies to assess their drugs’ risk of contributing to major adverse cardiac events (MACE). In most cases, large-scale studies are required to achieve statistical power for identifying MACE risks. Echo sub-studies, such as the one presented this week at ACC.10, may enable sponsors to develop cardiac risk profiles more rapidly and far less expensively.

Washington, DC and San Francisco, CA— Cardiocore, a premier centralized cardiac testing lab, announced today that its Chief Executive Officer, Jennifer Cotteleer and Vice President of Medical Operations, Polina Voloshko, MD, will present at Central Labs West on February 4-5, 2010. This conference will be hosted in San Francisco, California, where Cardiocore maintains a full-service core lab location supporting the local biotech community.

On Thursday, February 4th at 4:00pm (PST), Ms. Cotteleer will lead a roundtable discussion of biotech and pharmaceutical representatives sharing best practices in outsourcing and operations for cardiac and other imaging modalities. All interested conference attendees are invited to participate in this interactive session.

The following morning, at 11:00am (PST), Ms. Cotteleer will present Cardiac Safety Industry Trends. Applying her vast experience in cardiac studies and clinical data management, she will help attending conference delegates and speakers envision the future shape of cardiac testing in clinical trials.

Additionally, on Thursday, February 4th at 2:45pm, Dr. Voloshko will present Cardiac Safety Evaluation for Oncology Compounds. This session will examine the benefits of both electrocardiographic (ECG) and echocardiographic (ECHO) biomarkers. It will feature a case study demonstrating how a large pharmaceutical company used echocardiography to successfully identify reversible drug-induced cardiomyopathy in cancer patients.