|Medtronic Announces Results with Novel Approach to Cardiac Resynchronization Therapy; Cubist Presents Detailed Results from Positive Phase 3 Trials of Ceftolozane/Tazobactam|
|By Staff and Wire Reports|
|Friday, 09 May 2014 18:48|
Medtronic, Inc. (NYSE: MDT) released study findings that show heart failure patients who have limited options for implanted device therapy may benefit from a novel implant technique for cardiac resynchronization therapy (CRT) devices. Data from the ALSYNC (Alternate Site Cardiac Resynchronization) study show that pacing from inside the heart's left ventricle - an alternate site compared to traditional implants - was successful in 89 percent of implant attempts. The data were presented during a Late-Breaking Clinical Trials Session at Heart Rhythm 2014, the Heart Rhythm Society's 35th Annual Scientific Sessions, by Prof. John Morgan, M.D., Southampton University Hospitals Trust, Southampton, U.K. The system evaluated in the ALSYNC study is not available for investigational or commercial use in the United States.
Some heart failure patients are not suitable for, or do not respond to, traditional CRT because of limitations associated with implanting a lead, or thin wire, in veins on the outside of the left ventricle; these limitations may include unique patient anatomy or suboptimal lead placement. As a potential alternative for these patients, the system evaluated in the study implants a lead placed inside the left ventricle by crossing the atrial septum, the wall that divides the two top chambers of the heart.
"There is a significant need for a new way to pace the left ventricle in patients unable to receive the clinical benefits of standard CRT therapy, and this study suggests left ventricular endocardial pacing is a feasible option," said Prof. Morgan, lead investigator of the ALSYNC study. "These findings will elevate this new approach from something that is investigational to one that is closer to the mainstream."
The ALSYNC study, the first of its kind to evaluate the safety and performance of a new delivery system and left ventricular endocardial (LVE) pacing lead for CRT implantation, included 138 patients at 18 centers in Europe and Canada, all of whom were indicated for CRT but were unable to receive a conventional system or did not respond to the therapy at least six months post-implant. LVE pacing was successful in 118 out of 133 (89 percent) implant attempts.
The ALSYNC study assessed the safety and performance of the system and implant procedure. The primary objective was to demonstrate that the complication rates were less than 30 percent at six months in patients with an implant attempt. The objective was met with an observed rate of 17.7 percent (upper confidence bound 24.2 percent), which is comparable to the complication rates of conventional CRT implants1.
"As the leader in CRT, we are committed to continued innovations in heart failure treatment and bringing renewed hope to the many patients who have previously had limited options," said David Steinhaus, M.D., vice president and general manager, heart failure, and medical director for the Cardiac Rhythm Disease Management business at Medtronic.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced the first detailed results from positive pivotal Phase 3 clinical trials of its antibiotic candidate ceftolozane/tazobactam in development to treat serious infections including complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). Results will be presented at the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) being held in Barcelona May 10 - 13.
These new data include additional details on ceftolozane/tazobactam’s clinical cure and/or microbiological eradication rates, which met or exceeded pre-specified U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) non-inferiority margins, as well as details on the overall safety profile. Additionally, for the first time Cubist is presenting data on microbiological eradication of key problematic Gram-negative pathogens, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli) and Klebsiella pneumoniae. Microbiological eradication rates for ceftolozane/tazobactam were 84% - 100% in these pathogens across the cUTI and cIAI clinical trials, as detailed more fully below.
Growing antibiotic resistance poses a serious global health threat, as highlighted in the April 30, 2014 World Health Organization report. Collectively, the common Gram-negative pathogens E. coli, Klebsiella pneumoniae and Pseudomonas aeruginosa account for approximately one-third of all pathogens and 70% of all Gram-negative pathogens causing healthcare-associated infections (HAIs). These Gram-negative bacteria are common causes of urinary tract and intra-abdominal infections.
“We are delighted by the growing body of evidence indicating that ceftolozane/tazobactam may prove to be an important treatment option to address three of the most difficult to treat Gram-negative pathogens—specifically Pseudomonas aeruginosa and ESBL-producing E. coli and Klebsiella pneumoniae, —in cUTI and cIAI,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist. “Cubist hopes to make this new tool available to physicians and patients worldwide to help fight antimicrobial resistance, and looks forward to next steps in our global regulatory submissions.”
Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced financial results for the quarter ended March 31, 2014, and provided an update on company operations.
Arrhythmia Research Technology, Inc. (NYSE MKT:HRT), operates through its wholly-owned subsidiary Micron Products, Inc.
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that its executives are scheduled to present a corporate summary and update regarding the Company's development programs at the Bank of America Merrill Lynch Healthcare Conference in Las Vegas on Tuesday, May 13, 2014 at 3:00 p.m. Pacific Time.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today reported financial results for the first quarter 2014.
Coronado Biosciences, Inc. (Nasdaq:CNDO) inadvertently failed to file a press release as required by NASDAQ listing rule 5635c4 when it reported certain transactions on Form 8-K/A filed with the Securities and Exchange Commission on February 26, 2014.
Paulson Capital (Delaware) Corp., a publicly traded Delaware corporation (Nasdaq:PLCC), and privately owned Variation Biotechnologies (US), Inc., a Delaware corporation ("VBI"), announced today that they have signed a definitive merger agreement.
Ebix, Inc. (Nasdaq:EBIX), a leading international supplier of On-Demand software and E-commerce services to the insurance, finance and healthcare industries, today announced its plans to enter the field of telemedicine and consumer health markets, with the launch of A.D.A.M. OnDemand™.
Hemispherx Biopharma (NYSE MKT:HEB) announced its financial results for the three months ended March 31, 2014.
Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that Peter D. Meldrum, president and CEO of Myriad, is scheduled to present at the Bank of America Merrill Lynch 2014 Health Care Conference, at 10:00 a.m. Pacific on May 13, 2014, at the Encore at the Wynn in Las Vegas, Nevada.
Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has signed a Research Agreement with the University of Northern Colorado to perform initial studies in the development of cancer treatments that combine the proprietary live-cell encapsulation technology known as Cell-in-a-Box® with constituents of Cannabis known as cannabinoids.
Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), a research and development company with a primary focus in ophthalmology, today announced the initiation of a Phase II investigator sponsored clinical trial, OHR-005, testing Squalamine Eye Drops in patients with diabetic macular edema (DME).
Tauriga Sciences Inc. (OTCQB:TAUG), a diversified life sciences company with a proprietary microbial fuel cell technology and a pending acquisition in the medicinal cannabis space, has today provided shareholders with several updates to disclose meaningful progress realized by the Company in recent days.
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, announced the voting results from its Annual General and Special Meeting of Shareholders held Thursday May 8, 2014 in Vancouver, B.C.
TG Therapeutics, Inc. (Nasdaq:TGTX), an innovative, clinical-stage biopharmaceutical company, today announced that a conference call will be held on Tuesday, May 13, 2014 at 8:30 a.m. ET to discuss results for the first quarter of 2014 and provide a business outlook for the remainder of 2014.