Santaris Pharma and miRagen Therapeutics : Strategic Alliance to Develop microRNA-targeted Medicines for the Treatment of Cardiovascular Disease

June 23, 2010 — Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies and miRagen Therapeutics, Inc., a biopharmaceutical company focused on developing innovative microRNA-based therapeutics for cardiovascular and muscle disease, announced today that they have formed a strategic alliance to develop microRNA-targeted medicines for the treatment of cardiovascular disease.

Cardiovascular disease is the number one cause of death worldwide, claiming 17.1 million lives a year, or 29 percent of all deaths globally1. An estimated 81 million American adults – more than one in three – have one or more types of cardiovascular disease, which include high blood pressure, coronary heart disease, congenital cardiovascular defects, heart attack, chest pain, heart failure and stroke2.


miRagen is planning to develop and commercialize single-stranded LNA-based product candidates intended for the treatment of cardiovascular disease by utilizing Santaris Pharma A/S proprietary Locked Nucleic Acid (LNA) Drug Platform. Under the terms of the agreement, Santaris Pharma A/S received a minority equity interest in miRagen, and is eligible to receive milestone payments and royalties upon achievement of certain development and regulatory milestones. Financial terms of the collaboration were not disclosed... Santaris Pharma's Press Release - miRagen Therapeutics' Press Release -

NormOxys : Phase 1 Clinical Trial of Allosteric Effector of Hemoglobin, OXY111A

May 24, 2010 - NormOxys Inc., a biotechnology company developing a novel class of small molecule drugs which enhance the body’s ability to deliver oxygen to diseased tissues, announced that it has initiated a Phase 1 clinical trial of OXY111A, a novel allosteric modulator of affinity of oxygen to hemoglobin. NormOxys plans to initially develop this compound as a treatment for chronic heart failure and cancer indications. The Phase 1 trial will evaluate OXY111A in healthy volunteers at escalating dose levels.
The randomized, single-blind, ascending dose design will assess the safety, tolerability and pharmacokinetics of single intravenous doses of OXY111A in healthy volunteers. Biomarkers in this study include the measurement of P50, which evaluates the proof of pharmacology by quantifying changes in oxygen affinity produced by OXY111A as well as cardiopulmonary exercise testing to assess clinical improvements in oxygen delivery. Following this study will be safety and efficacy studies in chronic heart failure and oncology indications... [PDF] NormOxys' Press Release -

SORIN GROUP ACQUIRES GISH BIOMEDICAL

June 8, 2010 – Sorin Group, (Reuters Code: SORN.MI), a global company and a leader in the treatment of cardiovascular diseases, announced that it has acquired Gish Biomedical from Ventizz Capital Partners, a private equity group focused on technology-oriented companies.

Based in California, Gish Biomedical designs and manufactures disposable medical devices for cardiovascular surgery, with a focus on the Perfusionist. Gish products have been marketed both in the United States and worldwide for over 25 years... Sorin Group's Press Release - [PDF] GISH Biomedical's Press Release -

Medtronic's CoreValve® System : Long-Term Efficacy and Durability in Pivotal Trial

May 26, 2010 - Market-Leading Transcatheter Aortic Valve Delivers Positive Clinical Outcomes Through Two Years in Major International Study; Achieves 10,000-patient Milestone – New clinical data presented at EuroPCR demonstrate positive long-term performance and durability for the CoreValve transcatheter aortic valve replacement system from Medtronic, Inc. (NYSE: MDT). Two-year results from the pivotal 18-French CoreValve multicenter prospective study provide important additional evidence supporting wider use of the world’s market-leading transcatheter aortic valve.

The CoreValve system received CE (Conformité Européenne) Mark in March 2007. It is not yet available in the United States for clinical trial or commercial sale or use.

The CoreValve system, designed to replace a diseased aortic valve without open-heart surgery or surgical removal of the native valve, has now been implanted in more than 10,000 patients worldwide in 32 countries outside the United States. Typically delivered through the femoral artery, CoreValve is used in 75 percent of transarterial transcatheter valve replacement procedures... Medtronic's Press Release -

AstraZeneca : Marketing Authorisation Application To European Union For Cardiovascular Drug Axanum

04 June 2010 - AstraZeneca announced that it has submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for a product combining low-dose ASA (acetylsalicylic acid) and the active ingredient of Nexium (esomeprazole) for the prevention of cardio- and cerebrovascular (CV) events in patients requiring continuous low-dose ASA treatment who are at risk of developing ASA-associated gastric and/or duodenal ulcers. Pending approval, the proposed trade name for the product is Axanum.

Low-dose ASA, commonly known as aspirin, is a mainstay of therapy for patients at high risk of a CV event such as myocardial infarction or stroke. However, upper GI problems (including symptoms, ulcers and ulcer-related complications) are common reasons for discontinuing low-dose ASA therapy. Up to 30% of patients with upper GI problems discontinue or take deliberate breaks from their low-dose ASA treatment, which can place them at risk of a potentially life-threatening CV event as early as 8-10 days after discontinuation... AstraZeneca's Press Release -

CardioMEMS : CHAMPION Clinical Trial Study

June 1, 2010 - Study results indicate that the CardioMEMS implantable hemodynamic monitoring system significantly reduces the leading cause of hospitalizations in the U.S. - The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial met its primary efficacy endpoint with a 30% reduction in heart failure hospitalization rates at 6 months in heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, permanent wireless implant.

The results were presented this week at the European Society of Cardiology Heart Failure Congress 2010 in Berlin, Germany, by the principal investigators of the trial: William Abraham, M.D., Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center, and Philip Adamson, M.D., Director of the Heart Failure Institute at the Oklahoma Heart Hospital. The study was sponsored by CardioMEMS, Inc., a medical technology company that has developed a novel wireless sensing and communication technology for the human body... CardioMEMS' Press Release -

Trevena : Clinical Development of TRV120027, a First-in-Class Biased Ligand

April 14, 2010 - Trevena Inc., a leader in the discovery of G-protein coupled receptor (GPCR) biased ligands, announced the initiation of a Phase I clinical trial of TRV120027, a titratable i.v. agent designed for the treatment of acute decompensated heart failure. TRV120027 is a biased ligand that targets the angiotensin II type 1 receptor (AT1R) and induces a unique mode of signaling. It simultaneously blocks angiotensin-mediated G-protein signaling while stimulating AT1R-specific β-arrestin signaling. In preclinical studies, this biased signaling has demonstrated a unique range of biological effects that are highly advantageous to patients with acute heart failure... Trevena's Press Release -

Vicor Technologies : Results of PD2i® Analysis of MUSIC Trial Data

May 19, 2010 — David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), announced the initial results of a study designed to analyze data from the Merte Subita en Insufficiencia Cardiaca (MUSIC) Trial using its PD2i® algorithm and software. Vicor Technologies is a biotechnology company focused on the development of innovative, non-invasive medical devices using its patented, proprietary PD2i® nonlinear algorithm and software. Vicor develops diagnostics that accurately risk stratify specific target populations for future pathological events including cardiac death and autonomic nervous system dysfunction, and trauma victims in need of lifesaving intervention.

The study, titled "Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure," was conducted under a collaborative agreement with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona... Vicor Technologies' Press Release -

InVasc Therapeutics : Awarded Two Phase 1 SBIR Grants

May 19, 2010 – InVasc Therapeutics, Inc. announced that it has been awarded two Small Business Innovations Research (SBIR) Phase 1 grants by the National Institutes of Health. One grant is to continue research and development of small molecule drugs for the prevention and treatment of hypertension and stroke based on derivatives of alpha lipoic acid. The second grant is to advance the discovery and development of inhibitors of myeloperoxidase for use in treating or preventing acute vascular or inflammatory events. The aggregate funding from these two Phase 1 grants is nearly $400,000... [PDF] InVasc Therapeutics' Press Release -

Cardiola : m.pulse® system “immediately improves cardiac output under acute non-invasive Muscular CounterPulsation (MCP) treatment in patients with...

April 23, 2010 - Clinical study demonstrates that Cardiola’s m.pulse® system “immediately improves cardiac output under acute non-invasive Muscular CounterPulsation (MCP) treatment in patients with patients with stable CHF” (chronic heart failure) - Data presented at annual congress of the German Society of Cardiology — Cardiola AG announced that the Company’s CE-Marked m.pulse® Muscular CounterPulsation (“MCP”)-based system demonstrated “an immediate improvement of cardiac output with non-invasive means” in a patient population of advanced yet stable chronic heart failure. The effects could be shown in 22 patients over three consecutive days.... [PDF] Cardiola's Press Release -

Cordis : First Patients Enrolled In Trial of New Stent Graft System To Treat Abdominal Aortic Aneurysm

April 9, 2010 - Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technologies, announced that the first patients have been enrolled in the INNOVATION trial, which will assess the safety of a new stent graft system, called INCRAFT™, to treat abdominal aortic aneurysm (AAA). An estimated 27 million people worldwide have abdominal aortic aneurysms. Left untreated, all aneurysms will eventually rupture, and more than 80% of aneurysms that rupture result in death. In the U.S. alone, approximately 15,000 people die every year due to an AAA rupture... Cordis' Press Release (JNJ) -

HeartWare : Data From First 100 Patients in International Clinical and Commercial Experience Shows 90% Survival at 180 Days

April 23, 2010 -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, announced that data from its international clinical trial and commercial experience of the HeartWare® Ventricular Assist System showed a survival rate of 90 percent at six months and an actuarial survival rate of 86 percent at 12 months post implant. The results were presented by Martin Strueber, M.D., cardiothoracic surgeon at Hannover Medical School, at the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) held in Chicago this week... HeartWare International's Press Release -

Juventas Therapeutics : Phase I Clinical Trial of JVS-100 for Patients with Heart Failure

April 5 2010 - Juventas Therapeutics, Inc. is formerly known as AcelleRX Therapeutics, Inc. - Juventas Therapeutics, a privately held, clinical-stage regenerative medicine company announced it has started enrolling patients in a Phase I clinical trial for JVS-100 to evaluate safety and efficacy in the treatment of patients with Class III heart failure. JVS-100 encodes Stromal Cell-derived Factor-1 (SDF-1) and has been shown in pre-clinical studies to significantly increase cardiac function by promoting cell survival and increasing new blood vessel formation in the damaged organ. Specifically, the company completed studies in heart failure pig models demonstrating that JVS-100 treated pigs showed statistically significant improvements in key indicators of cardiac function and remodeling including reductions in left ventricular end systolic volume. Douglas Losordo, M.D., the Director of the Feinberg Cardiovascular Research Institute at Northwestern University serves as the Principal Investigator for the 16 person first-in-man, open-label, dose-escalation study. Also serving as Investigators are Drs. Farrell Mendelsohn, Director, Center for Therapeutic Angiogenesis Interventional & Regenerative Cardiovascular Medicine and Warren Sherman, the Director, Stem Cell Research and Regenerative Medicine for the Center for Interventional Vascular Therapies at Columbia University Medical Center... Juventas Therapeutics' Press Release -

Cardima : Surgical Ablation Probe Receives CE Mark Approval for the Surgical Treatment of Atrial Fibrillation

March 29, 2010 - Surgical Ablation System Capable of Closed-chest and Open-chest Ablation of Left and Right Atria to Mimic the MAZE Procedure - Cardima, Inc. (OTC/BB: CADM), a medical device company focused on the treatment of atrial fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System, announced that it has received CE Mark approval with an Indication for the Surgical Treatment of Atrial Fibrillation for its Surgical Ablation Probe. All components of the Cardima Surgical Ablation System are now approved for marketing for the treatment of AF in European countries recognizing CE Mark approval.

The Cardima Surgical Ablation System can be used in open-chest surgery in conjunction with other procedures, or as a thoracoscopic stand-alone, closed-chest procedure. The closed-chest procedure is significantly less invasive than current prevailing surgical treatments for AF. The Cardima Surgical Ablation System allows a trained cardiac surgeon to gain access to the heart through two or three small ports in the chest, making a large incision or sternotomy unnecessary... Cardima's Press Release -

ARCA biopharma : Special Protocol Assessment Agreement with FDA for Bucindolol Development in Genotype-Defined Heart Failure Population

May 17, 2010 - ARCA biopharma, Inc. (Nasdaq: ABIO) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. Bucindolol is the Company's investigational, pharmacologically unique, beta-blocker and mild vasodilator. An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. In November 2009, the Company announced that the FDA has designated as a Fast Track development program the investigation of bucindolol for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. In March 2010, ARCA was awarded a patent from the U.S. Patent and Trademark Office (USPTO) on methods of treating heart failure patients with bucindolol based on genetic testing.... ARCA biopharma's Press Release -

Phase 2 Clinical Trial Data Show Significant Improvements in Outcomes and Symptoms in Advanced Heart Failure Patients Treated with Celladon’s...

May 30, 2010 - Phase 2 Clinical Trial Data Show Significant Improvements in Outcomes and Symptoms in Advanced Heart Failure Patients Treated with Celladon’s Genetically Targeted Enzyme Replacement Therapy MYDICAR® - CUPID Trial Data Presented Today as Late-Breaker at Heart Failure 2010, the Annual Meeting of the Heart Failure Association of the European Society of Cardiology – Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced that six-month data from its Phase 2 clinical trial of MYDICAR® show improvements in clinical outcomes and disease markers in advanced heart failure patients treated with the genetically targeted enzyme replacement therapy.

The study met its primary safety and efficacy endpoints for high dose MYDICAR® versus placebo. The primary efficacy endpoint is a composite endpoint that encompasses the simultaneous assessment of patients’ clinical outcomes, exercise tolerance, heart failure symptoms, biomarkers, and cardiac function. Barry Greenberg, M.D., Professor of Medicine at the University of California, San Diego, presented the data in advanced heart failure patients as a late-breaking trial presentation at Heart Failure Congress 2010, the annual meeting of the Heart Failure Association of the European Society of Cardiology... Celladon's Press Release -

Aastrom Biosciences : First Patient Treated in Aastrom's U.S. Phase 2 Catheter Clinical Trial in Dilated Cardiomyopathy

May 17, 2010 - Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, announced that the first patient has been treated in the company's U.S. Phase 2 catheter-based clinical trial to treat dilated cardiomyopathy (DCM). Treatment was performed by interventional cardiologist Timothy D. Henry, M.D., FACC, at the Minneapolis Heart Institute® at Abbott Northwestern Hospital in Minneapolis, MN.

This prospective, randomized, controlled, multi-center clinical trial is designed to determine the safety and tolerability of Aastrom's tissue repair cells (TRCs), administered via catheter, in the treatment of patients with heart failure due to DCM. The trial seeks to enroll 12 ischemic DCM and 12 non-ischemic DCM patients. Within each group patients are randomized to receive either TRC treatment along with standard-of-care, or control treatment (standard-of-care only) in a 2:1 ratio. While the primary objective of the trial is to assess safety in patients with DCM, efficacy measures including cardiac dimensions, heart failure stage and other measures of cardiac function will be monitored... Aastrom Biosciences' Press Release -

Cardium : Agreement With bioRASI to Advance and Broaden Clinical Development of Generx Product Candidate

Feb 16, 2010 - Cardium Therapeutics (NYSE Amex: CXM) announced that it has entered into an agreement with bioRASI, an international contract research organization, to assist Cardium in the evaluation of Generx clinical development opportunities within major newly-industrializing markets in Eastern Europe, Asia and Latin America, for patients with chronic coronary artery disease who are either not optimal candidates for or do not have access to costly angioplasty/stenting or cardiac bypass surgery procedures.


Despite progress in the care and treatment of patients with cardiovascular disease in the industrialized world, heart disease remains a very serious problem in the U.S. and Europe, and advanced surgical procedures have been associated with considerable and increasing expense within already-burdened healthcare systems. The situation is even worse in other parts of the world. In many industrializing countries such as China, India and Russia, as well as in Latin America and the Middle East, the incidence of heart disease is rapidly increasing, and healthcare systems in many of these countries are unable to provide wide access to relatively expensive procedures such as coronary angioplasty and stenting, or cardiac bypass surgery (which in the U.S. can cost $50,000 to $100,000 over a five-year period following initial treatment)... Cardium Therapeutics' Press Release -

AngioScore : Favorable Results from the MASCOT Trial

March 12, 2010 - AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced favorable clinical trial results from the MASCOT Trial, an important study evaluating the AngioSculpt® PTA Scoring Balloon Catheter for the treatment of femoro-popliteal PAD (peripheral artery disease).

MASCOT (ClinicalTrials.gov NCT 00619788) was a prospective non-randomized European multi-center trial investigating the role of the AngioSculpt PTA Scoring Balloon Catheter for the treatment of severe femoro-popliteal stenotic disease (<= 8 cm in length). Patients with debilitating claudication (severe leg pain on walking) were treated at three pre-eminent European clinical sites with the recently introduced larger and longer AngioSculpt devices. Primary endpoints included safety at 30 days (complication-free survival) and target lesion patency at 12 months, as determined by Duplex ultrasound. The study results demonstrated an excellent safety outcome, with 96% of patients complication-free at 30 days, and a very favorable overall target lesion patency rate of 74.1% at 12 months. The study was conducted at two sites in Belgium and one site in Germany... AngioScore's Press Release -

Portola Pharmaceuticals and Merck : Phase 2 Study Showed Investigational Factor Xa Inhibitor, Betrixaban, Reduced Incidence of Bleeding Compared to...

March 15, 2010 – Portola Pharmaceuticals and Merck announced the results of EXPLORE-Xa, a Phase 2 exploratory, dose finding study of betrixaban, an investigational oral direct Factor Xa inhibitor. Results showed that a once-daily dose of oral betrixaban, given to patients with non-valvular atrial fibrillation or atrial flutter and at least one risk factor for stroke, reduced the incidence of major and clinically relevant non major (CRNM) bleeds compared to dose-adjusted warfarin.


The data were presented during a late-breaking clinical trials session at the American College of Cardiology (ACC) 59th Annual Scientific Session in Atlanta... [PDF] Portola Pharmaceuticals' Press Release - Merck's Press Release -

Isis Pharmaceuticals : $6 Million Milestone Payment From Bristol-Myers Squibb for BMS-PCSK9Rx

March 8, 2010 - Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced that it has earned a $6 million milestone payment from Bristol-Myers Squibb Company (NYSE: BMY) related to the acceptance of initial regulatory filings to begin Phase 1 clinical studies for BMS-PCSK9Rx.



BMS-PCSK9Rx is an antisense drug that arose out of the ongoing collaboration between Bristol-Myers Squibb and Isis to identify antisense drugs targeting PCSK9 to lower low-density lipoprotein (LDL) cholesterol... Isis Pharmaceuticals' Press Release -

Ischemix : Phase 2a Clinical Trial

March 9, 2010 - Ischemix announced the initiation of patient accrual in a multi-center Phase 2a clinical trial of CMX-2043 for the prevention of peri-operative ischemia-reperfusion injury in patients undergoing elective percutaneous coronary intervention (PCI) procedures. CMX-2043 is a cardio-protective drug that combines Akt pathway-mediated cell survival effects and anti-oxidant activity in a single small molecule.... Ischemix's Press Releases -

BG Medicine and Abbott : to Develop Galectin-3 Test for the i-STAT® System

March 8, 2010—BG Medicine, Inc. announced that it has entered into an agreement with Abbott Laboratories (NYSE: ABT) to extend its current development and commercialization collaboration to include the development of a galectin-3 test for Abbott Point of Care’s i-STAT System. Galectin-3 is a novel biomarker that may play a role in detecting the development and progression of heart failure.



Under the agreement, Abbott will be responsible for the development of the test in accordance with certain plans and milestones, and BG Medicine and Abbott will collaborate in support of regulatory filings and studies to support the clinical utility of galectin-3 in the management of patients with acute decompensated heart failure... BG Medicine's Press Release -