At this year's American Heart Association (AHA; Dallas, Texas) Scientific Sessions, Boehringer Ingelheim (Ingelheim, Germany) reported the launch of what it called the largest cardiovascular study in company history. The PROTECTION study will build on the ONTARGET trial (for Ongoing Telmisartan Alone in combination with Ramipril Global Endpoint Trial), announced earlier this year, and investigate the effect of the angiotensin II receptor blocker (ARB) Micardis (telmisartan) on blood pressure control in special populations, such as the elderly and people with diabetes. Micardis is co-marketed in the U.S. by Abbott Laboratories (Abbott Park, Illinois). PROTECTION will include 10 studies enrolling about 6,000 patients in North America, Europe and South Africa, plus the 28,400 patients who enrolled at 793 ONTARGET sites worldwide. The PROTECTION program will begin in the next 12 to 15 months and is expected to be completed in early 2005, with interim results in 2003.
Because high blood pressure is a risk factor for cardiovascular events, including myocardial infarction, stroke and cardiovascular death, researchers hope to learn how organs such as the heart and kidneys can be protected in patients with high blood pressure. ONTARGET is analyzing the role of an ARB and an angiotensin converting enzyme (ACE) inhibitor alone or in combination in the prevention of stroke, myocardial infarction, cardiovascular death and hospitalization for congestive heart failure. It is expected to provide data comparable to the Heart Outcomes Prevention Evaluation (HOPE) trial in 1999. The HOPE trial found that the ACE inhibitor ramipril reduces the combined risk of stroke, myocardial infarction and cardiovascular death by 22%.
Angiotensin II, a naturally occurring hormone, causes constriction of blood vessels and increases blood pressure. Both ARBs and ACE inhibitors lower blood pressure by acting on angiotensin II. ARBs block the receptor sites found in many tissues for angiotensin II, one of the body's most powerful vasoconstrictors. ACE inhibitors widen blood vessels and block the production of angiotensin II, thus lowering blood pressure.
NexCura to develop web decision support
NexCura (Seattle, Washington), a developer of web-based, clinical decision-support software for patients with chronic diseases, has been selected by the American Heart Association to serve as a partner in developing and distributing web-based technology for both consumers and physicians. NexCura will initially develop Internet-based decision support technology for congestive heart failure (CHF) and coronary artery disease(CAD) for launch on AHA's web site, www.americanheart.org, later this year. AHA will provide expertise from its scientific councils to participate in the medical editorial boards that oversee the identification and selection of leading scientific studies for the Heart Profiler tools. AHA and NexCura will co-brand the Heart Profilers for distribution to local, regional and national web sites of academic medical centers, hospitals, physicians, managed care organizations, advocacy groups and health portals.
Using a patient's clinical profile, including diagnosis and test results, the Heart Profiler will match individual patients to peer-reviewed clinical research studies and provide treatment options, side effects descriptions and questions that patients can discuss with their health care providers. Patients using the Internet Heart Profiler also will have access to summaries of the latest studies related to their clinical status. The professional tools will enable physicians to evaluate literature based on patient case modeling methods.
NexCura CEO Dr. Stephen George said that the alliance with AHA "provides patients and practicing health care professionals with medically credible, patient-specific treatment information that enhances the patient-physician dialogue and allows them to make better use of consultation time while improving patient satisfaction and outcomes."
Collateral receives gene therapy patent
Collateral Therapeutics (San Diego, California) has received U.S. patent No. 6,306,830, "Gene Therapy for Congestive Heart Failure," covering methods of in vivo gene transfer via non-surgical administration for the potential treatment of congestive heart failure. The technology covered by the patent was exclusively licensed from the University of California. The patent is directed to methods using a gene delivery vector and a therapeutic gene encoding a beta-adrenergic signaling element, particularly a cardiac adenylylcyclase (AC) gene, to enhance cardiac function for CHF patients. In the company's preclinical studies, use of a cardiac AC gene to enhance the myocardial adrenergic signaling pathway resulted in statistically significant increases in cardiac function as reported in the journal Circulation last year.
"This patent expands Collateral's intellectual property position in the important therapeutic area of congestive heart failure and provides opportunities for applying our technologies to the development of new cardiovascular gene therapies," said Jack Reich, PhD, chairman and CEO. Collateral Therapeutics is developing non-surgical cardiovascular gene therapy products focused on angiogenesis, myocardial adrenergic signaling and heart muscle degeneration.
Ranolazine data boost CV Therapeutics
CV Therapeutics (Palo Alto, California) saw an upward spike of more than 26% in its share price last month (to more than $48 per share) following rollout of positive data at the AHA Scientific Sessions for its experimental drug ranolazine, which lets the heart burn sugar for energy. The primary trial goal was to determine the amount of time patients taking ranolazine could exercise without being limited by symptoms of angina. Chairman and CEO Louis Lange said the trial also met 16 out of 18 secondary goals, including episodes of angina.
In the trial, the drug met its goal of extending exercise time in patients with cardiac pain and showed that the pill cuts the number of angina attacks. Ranolazine is the first in a new class of compounds known as partial fatty acid inhibitors. It works by directing the heart muscle to burn glucose, a fuel that requires relatively little oxygen to be metabolized, rather than fat. Used in combination with other angina drugs, ranolazine increased treadmill exercise time by 24 seconds compared to a placebo, according to Dr. Bernard Chaitman, the trial's lead investigator. Chaitman, director of cardiovascular research at St. Louis University School of Medicine (St. Louis, Missouri), said the results "raise the bar on what a patient is able to do before feeling pain."
Chaitman said that the 12-week, 823-patient trial showed that the drug cut by 25% the incidence of chest pain attacks in patients with chronic symptoms. That 25% increase translates to "a huge leap in quality of life," according to Lange, who noted that people tend to alter their lifestyle for fear of heart attacks. He also said that, although the trial was not designed to measure survival, half as many patients on the treatment side of the ranolazine trial died compared to patients getting placebo.
Chaitman said that ranolazine had only minimal effects on heart rate and blood pressure, adding that drugs currently available "affect heart rate, blood pressure and pumping function, making them hard to use in patients with other conditions, such as heart failure or lung disease." He said the trial revealed a slight increase in the risk of arrhythmia from ranolazine, but that risk was no higher than that found in other anti-anginal treatments. "The side effects were 6% to 8% over placebo, but that compares to 34% to 40% with current drugs."CV Therapeutics said it plans to file sometime in the second half of next year for FDA approval of the drug.
Emergency services select Survivalink
Cardiac Science (Irvine, California) reported that a group of police, fire and emergency medical service agencies will purchase 325 of its Survivalink automated external defibrillators (AEDs). The Florida State Highway Patrol purchased 37 AEDs for use in police and trooper vehicles, bringing the total of its Survivalink AEDs in service to 124. The city of Cedar Rapids, Iowa, selected Cardiac Science to equip its police department with 41 AEDs. Other agencies making purchases include the Cook County (Illinois) Sheriff Department, the Collin County (Texas) Sheriff Department and the state of Wisconsin Department of Justice. The Custer County Sheriff's Department, Clinton Police Department and Weatherford Police Department, all in Oklahoma, also have purchased AEDs.
Fire and emergency medical services agency deployments of Cardiac Science AEDs include the Akron (Ohio) Fire Department, Hartsfield International Airport fire department (Atlanta, Georgia), the Baton Rouge (Louisiana) Volunteer Fire Department and Porter County (Indiana) EMS. The city of Boston has purchased 40 AEDs, part of a 1,100-unit contract signed earlier this year. The initial units are being deployed in city ambulances and by the city's paramedic bike service, which acts as a safeguard at the Boston Marathon, concerts and other public events.
The company estimates that, nationwide, only about 20% of fire engines and 5% of police and sheriff vehicles are currently equipped with AEDs. Raymond Cohen, president and CEO of Cardiac Science. "Widespread deployment of AEDs by police and firefighting agencies could prevent many of the 350,000 annual deaths attributed to sudden cardiac arrest."
The value of AEDs in the airport environment has been demonstrated by American Airlines (Fort Worth, Texas), which recently reported that more than two dozen people are alive because of the presence of the devices on its aircraft, with the latest "save" coming on Oct. 31 at a boarding gate in Chicago. American, which uses AEDS from Heartstream (Seattle, Washington), now part of Philips Medical Systems (Best, the Netherlands), was the first domestic airline to equip its fleet with AEDs, the first installed in May 1997. Since then, 27 people have had their lives extended due to the availability of an onboard defibrillator, the airline said.
American Eagle, American's regional affiliate, also has defibrillators on all of its aircraft. And installation will be completed on all aircraft acquired as part of American's purchase of TWA by Dec. 31. The devices also have been installed at American's headquarters and two maintenance bases.
Frost & Sullivan (San Jose, California) has estimated that the worldwide market for AEDs will expand to more than 250,000 units a year by 2006, accounting for some $650 million in sales.