Advanced HF News, 1st Patient Dosed in Phase 2b Trial

Celladon Corporation Announces First Patient Dosed in CUPID Phase 2b Trial of MYDICAR® for Advanced Heart Failure. Full press release follows. SOURCE: Celladon Corporation SAN DIEGO, Aug. 29, 2012 /PRNewswire/ -- Celladon Corporation, a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced today that it has dosed the first patient in a Phase 2b clinical trial of MYDICAR, Celladon's first in class therapeutic for the treatment of advanced heart failure (HF). Chronic HF is a leading cause of hospitalization and resulted in direct and indirect costs of $39.2 billion to the U.S. healthcare system in 2010. Nearly 6 million people in the U.S. have HF and at least 670,000 new cases are diagnosed yearly. Heart failure leads to an estimated 280,000 deaths annually. There is no cure. The Phase 2b study titled "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease" ("CUPID Phase 2b Trial") is a multinational, multicenter, double-blind, placebo-controlled, randomized study of a single intracoronary administration of 1 x 1013 DRP MYDICAR versus placebo added to an optimal HF regimen. The primary objective is to determine the efficacy of MYDICAR in patients with ischemic or dilated cardiomyopathy and NYHA class III/IV symptoms of HF by reducing the frequency and/or delaying HF-related hospitalizations compared to placebo-treated patients. Secondary objectives will include assessment of the safety of MYDICAR by determining the incidence and severity of adverse events and changes in laboratory parameters. The trial will enroll approximately 200 patients in up to 50 international sites. Results are anticipated in the first half of 2015. The Chairman of the Executive Clinical Steering Committee of the CUPID Phase 2b Trial is  Barry H. Greenberg M.D., FACC, Director, Advanced Heart Failure Treatment Program; Professor of Medicine,University of California, San Diego. Dr. Greenberg stated, "We are enthusiastically looking forward to evaluating MYDICAR in the CUPID Phase 2b Trial for advanced heart failure. There is a major unmet need to provide safe and effective therapies for patients with advanced heart failure such as the ones who we will be studying in this trial." "With the encouraging results from the preceding CUPID Phase 2 trial and the timely dosing of the first patient in this Phase 2b trial, we are firmly on track with our plan to develop a novel, safe, and effective therapy for patients with advanced heart failure," said Krisztina Zsebo Ph.D., President and CEO of Celladon Corp.   The first patient was dosed at Sharp Memorial Hospital in San Diego, CA by Brian Jaski, M.D., FACC, and Scientific Director of Research at the San Diego Cardiac Center. "We are grateful to be able to collaborate with Celladon for new innovative therapies for patients with serious heart failure.  Heart failure is an increasing medical problem with no major breakthrough in medication therapy in over twenty years.  Thus, there exists a large unmet need to help these patients." noted Dr. Jaski. About the CUPID Phase 2b Trial The CUPID Phase 2b trial will enroll approximately 200 patients in up to 50 sites worldwide.  Patients will first be prescreened for the presence of AAV neutralizing antibodies. Those patients with a negative titer will undergo further screening tests and procedures to determine eligibility prior to randomization and enrollment into the study. All patients will be randomized in parallel to MYDICAR or placebo in a ratio of 1:1 (1 x 1013 DRP MYDICAR to placebo). The primary objective is to determine the efficacy of MYDICAR in patients with ischemic or dilated cardiomyopathy and NYHA class III/IV symptoms of HF by reducing the frequency and/or delaying HF-related hospitalizations compared to placebo-treated patients. The primary efficacy endpoint is time-to-recurrent HF-related hospitalizations in the presence of terminal events (all-cause death, heart transplant, LVAD implantation). The secondary efficacy endpoint is the time-to-terminal event (all-cause death, heart transplant, LVAD implantation). Exploratory endpoints include change from baseline in NYHA class, 6 minute walk test distance, and quality of life (KCCQ) score. Secondary objectives will include assessment of the safety of MYDICAR by determining the incidence and severity of adverse events and changes in laboratory parameters. Safety evaluations include the incidence and severity of all adverse events (including procedure-related), summaries of concomitant medications, vital signs, physical exams, implantable cardioverter defibrillator (ICD) interrogations and laboratory parameters, and the time to cardiovascular-related death. About MYDICAR MYDICAR is a genetically targeted enzyme replacement therapy intended to restore levels of SERCA2a, a regulator of calcium cycling in the heart and cardiac contractility. SERCA2a levels decline in all forms of late-stage HF resulting in deficient heart function. With MYDICAR, the SERCA2a gene is delivered using recombinant adeno-associated virus (AAV) as the vector. AAV is a naturally occurring virus not associated with any disease in humans. MYDICAR is delivered in a single dose directly to the heart during a routine outpatient cardiac catheterization procedure, similar to an angiogram. MYDICAR is synergistic and additive across current HF treatments such as ACE inhibitors, beta-blockers, sprinolactone/diuretics, and biventricular pacing devices. No treatment substitution decision is required by the treating physician. SOURCE Celladon Corporation CONTACT: Kristina Zsebo, PhD, President & CEO, +1-858-366-4288, kzsebo@celladon.net Web Site: http://www.celladon.net

Researchers Set Record for Detecting Smallest Virus

Researchers Set Record for Detecting Smallest Virus, Opening New Possibilities for Early Disease Detection. Full press release follows. SOURCE: Polytechnic Institute of New York University NEW YORK, Aug. 28, 2012 /PRNewswire/ -- Researchers at Polytechnic Institute of New York University(NYU-Poly) have created an ultra-sensitive biosensor capable of identifying the smallest single virus particles in solution, an advance that may revolutionize early disease detection in a point-of-care setting and shrink test result wait times from weeks to minutes.  (Logo: http://photos.prnewswire.com/prnh/20091027/NY99197LOGO ) Stephen Arnold, university professor of applied physics and member of the Othmer-Jacobs Department of Chemical and Biomolecular Engineering, and researchers of NYU-Poly's MicroParticle PhotoPhysics Laboratory for BioPhotonics (MP3L) reported their findings in the most recent issue of Applied Physics Letters, published by the American Institute of Physics. Their technique is a major advance in a series of experiments to devise a diagnostic method sensitive enough to detect and size a single virus particle in a doctor's office or field clinic, without the need for special assay preparations or conditions. Normally, such assessment requires the virus to be measured in the vacuum environment of an electron microscope, which adds time, complexity and considerable cost. Instead, the researchers were able to detect the smallest RNA virus particle MS2, with a mass of only 6 attograms, by amplifying the sensitivity of a biosensor. Within it, light from a tunable laser is guided down a fiber optic cable, where its intensity is measured by a detector on the far end. A small glass sphere is brought into contact with the fiber, diverting the light's path and causing it to orbit within the sphere. This change is recorded as a resonant dip in the transmission through the fiber. When a viral particle makes contact with the sphere, it changes the sphere's properties, resulting in a detectable shift in resonance frequency. The smaller the particle, the harder it is to record these changes. Viruses such as influenza are fairly large and have been successfully detected with similar sensors in the past. But many viruses such as Polio are far smaller, as are antibody proteins, and these require increased sensitivity.  Arnold and his co-researchers achieved this by attaching gold nano-receptors to the resonant microsphere. These receptors are plasmonic, and thus enhance the electric field nearby, making even small disturbances easier to detect.  Each gold "hot spot" is treated with specific molecules to which proteins or viruses are attracted and bind. Arnold explained that the inspiration for this breakthrough technique came to him during a concert by violinist Itzhak Perlman: "I was watching Perlman play, and suddenly I wondered what would happen if a particle of dust landed on one of the strings. The frequency would change slightly, but the shift would be imperceptible. Then I wondered what if something sticky was on the string that would only respond to certain kinds of dust?" In experiments, the researchers successfully detected the smallest RNA virus in solution, and they are now training their sights on detecting single proteins, which would represent a major step toward early disease detection. "When the body encounters a foreign agent, it responds by producing massive quantities of antibody proteins, which outnumber the virus. If we can identify and detect these single proteins, we can diagnose the presence of a virus far earlier, speeding treatment," Arnold said. "This also opens up a new realm of possibilities in proteomics," he said, referring to the study of proteins. "All cancers generate markers, and if we have a test that can detect a single marker at the protein level, it doesn't get more sensitive than that."  This patent-pending technology, co authored with postdoctoral fellow Siyka Shopova and graduate student Raaj Rajmangal, is ultimately designed for a point-of-care device capable of detecting viruses or disease markers in blood, saliva or urine. Testing for commercial applications is already under way. The sensor itself, called a Whispering Gallery-Mode Biosensor, is unique to Arnold's work. Its name derives from the famous Whispering Gallery in the dome of St. Paul's Cathedral in London. Much the way its unique acoustics allow a whisper to be heard anywhere within the circular gallery, light traveling within the glass sphere of the biosensor orbits many times, ensuring nothing on the surface is missed. The technique was pioneered by NYU-Poly MP3L post-doctoral researchers, graduate and undergraduate students, along with Stephen Holler, NYU-Poly alum and now an assistant professor of physics atFordham University. A technology entrepreneur, Holler founded NovaWave Technologies, a chemical sensor company, at one of NYU-Poly's business incubators. Thermo Fisher Scientific, one of the world's leading providers of scientific and laboratory equipment, acquired NovaWave in 2010. Other authors of the paper are Venkata Dantham, NYU-Poly postdoctoral fellow; Vasily Kolchenko, now professor at New York City College of Technology's Department of Biological Sciences; and Zhenmao Wan, currently a graduate student in the Department of Physics at Hunter College of CUNY. This research was originally supported by provost seed funds from the New York University (NYU) School of Arts and Sciences, in a grant jointly awarded to Arnold and NYU Professor of Physics David Grier. The National Science Foundation provided additional funding. About Polytechnic Institute of New York University Polytechnic Institute of New York University (formerly Polytechnic University), an affiliated institute ofNew York University, is a comprehensive school of engineering, applied sciences, technology and research, and is rooted in a 158-year tradition of invention, innovation and entrepreneurship: i2e. The institution, founded in 1854, is the nation's second-oldest private engineering school. In addition to its main campus in New York City at MetroTech Center in downtown Brooklyn, it also offers programs at sites throughout the region, around the globe and remotely through NYUe-Poly. NYU-Poly is an integral part of NYU Abu Dhabi, NYU Shanghai and the NYU Center for Urban Science and Progress (CUSP) in downtown Brooklyn. For more information, visit www.poly.edu. SOURCE Polytechnic Institute of New York University  NOTE TO EDITORS: To download image, visit http://research.poly.edu/~resourcespace/?c=883&k=ba099b8f8f CONTACT: Kathleen Hamilton, +1-718-260-3792 office, +1-347-843-9782 mobile, hamilton@poly.edu Web Site: http://www.poly.edu

RT APCO Insight: Biopharma Trends & Executive Engagement

The Next Face of the Biopharmaceutical Industry

Source: APCO Insight, www.apcoinsight.com

Author: Lynn Pellicano is an associate research director for APCO Insight in the Washington, D.C. office.

Full text follows --

Today’s biopharmaceutical companies arguably face more research and development (R&D) challenges than ever before.  Despite an industry-wide surge in the past decade that has nearly doubled investments in R&D, the FDA has approved considerably fewer new drugs. Add in brand names going off patent, increased competition with generics, upsets in late-phase clinical trials and dwindling pipelines, and biopharmaceutical companies are in a rough place, often finding that they don’t have enough revenue to sustain levels of R&D.  It’s no wonder why in the last five years we have been witness to several large biopharmaceutical companies buying out the entrepreneurial talent of smaller biopharmaceutical companies with more promising pipelines. At the same time, public trust and confidence in the industry (as evidenced by ample research on the topic) has steadily been declining.

As I sit here scratching my head, thinking about what do to reinvigorate public confidence in an industry plagued with such challenges, I turn to the results of this past year’s ROR Indicator: State of the Biopharmaceutical Industry for some guidance. What immediately caught my eye was that the importance of Executive Engagement significantly increased in 2011 but remained a vulnerability for the industry as a whole. This got me thinking about successful leaders in other industries such as Steve Jobs and Bill Gates, and how their strong leadership often served to their own advantage amid controversy or challenges. If it worked so well for them, why aren’t the “leaders” of the biopharmaceutical industry following suit? Executive leadership is desperately needed to bolster public confidence. In its absence, confidence in the industry continues to corrode.

As the results show, there is an increased burden for industry executives to step up to the plate and demonstrate leadership on these issues. Their non-response is actually hurting the already blemished image of biopharmaceutical companies.

So, who should executives talk to? A good place to start would be engaging health care opinion leaders (the top 10 percent of the most active and engaged segment of the general public who are knowledgeable about health care issues; they are also the ones that policy-makers listen to when making or influencing public policy). Interestingly, the data shows a significant positive correlation between performance on Executive Engagement and the ability of the industry to mobilize advocates–suggesting that opinion leader perceptions of the industry can be positively impacted simply by the act of making executives more visible.

But what about what they need to say? Executives need to do a better job at demonstrating the industry’s value proposition. Specifically, they need to communicate that the nature of biopharmaceutical R&D has always been traditionally slower than innovation in other industries. And even though biopharmaceutical companies may be in a tough place at the moment, it doesn’t mean they aren’t being productive. In fact, it’s quite the opposite. More companies are actually investing in R&D for potential therapies that aim to respond to public health needs than in year’s past – especially for chronic and rare diseases. Not only are the costs associated with chronic and rare disease particularly high, but they often have a long-lasting impact on a patient’s quality of life. By investing in such R&D, biopharmaceutical companies are actually charting a course forward to reduce costs to the health care system as a whole, cure devastating illnesses, and improve quality of life.

So then, who’s the next (arguably, the first) face of the biopharmaceutical industry, the one that puts this all in perspective and calms our nerves? That is yet to be determined.

Findings from the latest tracking phase are now available to member companies. Specifically, this Return on Reputation Indicator explores the evolving expectations of key stakeholders. In addition, we are preparing for the next tracking phase and expect the survey fieldwork to begin in October 2012.

For more information, please visit www.rorindicator.com – or contact Chrystine Zacherau (czacherau@apcoinsight.com).

Acquisition News: Siemens Healthcare to Acq Penrith Corp

Siemens Healthcare Enters into Definitive Agreement to Acquire Penrith Corporation. Acquisition of ultrasound equipment systems manufacturer to expand Healthcare's ultrasound portfolio. Full press release follows. SOURCE: Siemens Healthcare MOUNTAIN VIEW, Calif. and PLYMOUTH MEETING, Pa., Aug. 21, 2012 /PRNewswire/ -- Today Siemens Healthcare (NYSE: SI) announced that the company has entered into a definitive agreement to acquire substantially all of the assets of Penrith Corporation of Plymouth Meeting, Pa., a manufacturer of integrated ultrasound imaging systems. Through this acquisition, Siemens will offer new and improved diagnostic capabilities. The deal is expected to close in September 2012. "This acquisition uniquely positions Siemens to bring new, meaningful solutions to the ultrasound market and to expand our presence in attractive business segments," said Jeffrey Bundy, CEO, Siemens Healthcare Ultrasound Business Unit. "Through this acquisition, Siemens is executing its strategic focus, announced via Agenda 2013, on strengthening the Healthcare Sector's innovative power and competitiveness. We welcome the addition of Penrith's highly experienced ultrasound employees to the Siemens Healthcare family." "We are very pleased to join Siemens Healthcare," said Michael G. Cannon, President, Penrith Corporation, who upon closing of the transaction will become Siemens Ultrasound's Vice President and General Manager, Point-of-Care Solutions. "Our portfolio and technology competence in the miniaturization of ultrasound devices will strengthen Siemens' ability to develop pioneering technologies and future breakthrough innovations that advance and expand ultrasound's role in medicine – specifically, innovations that are tailored to the needs and means of diverse markets." For more information about Siemens Healthcare's ultrasound solutions, please visit www.siemens.com/ultrasound Launched by Siemens Healthcare Sector in November 2011, Agenda 2013 is a two-year global initiative to further strengthen the Healthcare Sector's innovative power and competitiveness. Specific measures will be implemented in four fields of action: Innovation, Competitiveness, Regional Footprint, and People Development. The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 51,000 employees worldwide and operates around the world. In fiscal year 2011 (to September 30), the Sector posted revenue of 12.5 billion euros and profit of around 1.3 billion euros. For further information please visit:www.siemens.com/healthcare SOURCE Siemens Healthcare CONTACT: Media Relations: Lance Longwell, Siemens Medical Solutions USA, Inc., Healthcare Sector - Clinical Products, +1-610-448-1473, lance.longwell@siemens.com Web Site: http://www.siemens.com/healthcare

NIAID awards grants to develop computational tools for Tb drug discovery

National Institute of Allergy and Infectious Diseases Awards Grant to Continue Development of Computational Tools for Tuberculosis Drug Discovery.

Full press release follows.

SOURCE: SRI International

MENLO PARK, Calif., Aug. 16, 2012 /PRNewswire/ -- The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded a second grant to Collaborative Drug Discovery, Inc. and SRI International to continue joint development of an information repository and software to identify novel therapeutics for tuberculosis (TB).
The Phase II Small Business Technology Transfer Research (STTR) grant will support the next two years of research and focus on extending a systems biology-cheminformatics approach to develop molecular mimics and computationally evaluate them for drug efficacy.
CDD and SRI researchers will further evaluate molecules discovered in Phase I, expand the scope of search for lead molecules for TB, and develop a software product for bioscience research use. The software will provide powerful query and analysis capabilities, and include links to other drug discovery tools and databases. 
"After successful completion of Phase I, where we integrated intensive data mining, curation and computational approaches to suggest biological targets and their small molecule modulators, we now look forward to follow-up studies that will refine and validate our approach," said Carolyn Talcott, Ph.D., program director, Information & Computer Science Division at SRI International.
"We are excited to continue our work on this project, which has already resulted in multiple publically accessible datasets that include results of experimental assays and information about drug compounds," said Sean Ekins, Ph.D., vice president, Science at CDD. "We will build upon the demonstrated proof-of-concept to identify more compounds active against tuberculosis to include in the repository."
"The validation of our approach focusing on neglected diseases such as tuberculosis and their research communities has enabled us to develop a technology that can be used for secure sharing of data and is broadly useful," said Barry Bunin, president & CEO of CDD, "We welcome the opportunity to work with other groups to develop our combined ideas into fundable research projects and ultimately commercial products."
The project described was supported by Award Number 2 R42 AI088893-02 from the National Institute of Allergy and Infectious Diseases. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.
About Collaborative Drug Discovery, Inc.
CDD (www.collaborativedrug.com) provides the most widely used web-based drug discovery software platform on the market. "CDD Vault™" is the secure, private industrial-strength database combining traditional drug discovery informatics (registration and SAR) with social networking capabilities. "CDD Collaborate™" enables real-time collaboration by securely exchanging selected confidential data with external researchers. "CDD Public™" enables researchers to mine a unique aggregation of information from a variety of scientific data providers.
About SRI International
Innovations from SRI International have created new industries, billions of dollars of marketplace value, and lasting benefits to society—touching our lives every day. SRI, a nonprofit research and development institute based in Silicon Valley, brings its innovations to the marketplace through technology licensing, new products, and spin-off ventures. Government and business clients come to SRI for pioneering R&D and solutions in computing and communications, chemistry and materials, education, energy, health and pharmaceuticals, national defense, robotics, sensing, and more.
SOURCE SRI International

CONTACT: Dina Basin, SRI International, (650) 859-3845, dina.basin@sri.com; Barry Bunin, PhD, Collaborative Drug Discovery, (650) 204-3084, info@collaborativedrug.com; Ellie Javadi, SRI International, (650) 859-4874, ellie.javadi@sri.com

Kroger to offer self-use health assessment kiosks

Kroger Family of Pharmacies to Offer Health Assessment Kiosks at Locations Nationwide. Full press release below. SOURCE: The Kroger Company CINCINNATI, Aug. 14, 2012 /PRNewswire/ -- The first step to improving health and wellness is to know where you stand today. To help customers "know their numbers", The Kroger Co. (NYSE:KR) Family of Pharmacies announced today it will place self-use health screening kiosks at all 1,950 locations nationwide. The Kroger HealthCENTER kiosks, provided by Stayhealthy, Inc., a California-based wellness solutions company, provide customers with an easy, free and secure solution to consistently measure, monitor and improve body composition and other clinical conditions. Assessments include blood pressure, weight, body composition, BMI, color vision and the ability to upload blood glucose numbers and other biometric results.  "Our customers tell us they want to make healthy choices but don't always know where to start," saidMatthew Feltman, Kroger's health strategy coordinator. "We're pleased to expand the availability of Kroger HealthCENTERs to help customers take their first steps toward overall health and wellness." Kroger customers will be able to create personal health record accounts, which they can access at any time at Kroger.com, to chart their progress. They will also have access to health information and solutions designed to help them in their personal health and fitness goals. Kroger has been piloting the HealthCENTERs in approximately 275 pharmacy locations since January. The kiosks are currently accessible to customers in Cincinnati, OH, Lexington, KY, and Denver, CO.Kroger expects most other pharmacy locations will have the kiosks by early 2013. About Kroger Kroger, one of the world's largest retailers, employs more than 339,000 associates who serve customers in 2,425 supermarkets and multi-department stores in 31 states under two dozen local banner names including Kroger, City Market, Dillons, Jay C, Food 4 Less, Fred Meyer, Fry's, King Soopers, QFC, Ralphs and Smith's. The company also operates 789 convenience stores, 337 fine jewelry stores, 1,109 supermarket fuel centers and 38 food processing plants in the U.S. Recognized by Forbes as the most generous company in America, Kroger supports hunger relief, breast cancer awareness, the military and their families, and more than 30,000 schools and grassroots organizations in the communities it serves. Kroger contributes food and funds equal to 160 million meals a year through more than 80 Feeding America food bank partners. For more information please visit Kroger.com. About Stayhealthy, Inc. Stayhealthy, Inc. is a privately-owned healthcare solutions corporation headquartered in Monrovia, California.  Since 1995, Stayhealthy has been committed to changing the way the world measures health fitness and has built a world-wide reputation within the research community for providing the highest-quality, FDA-cleared health measurement products.  SOURCE The Kroger Co. CONTACT: Kroger Contacts: Media: Keith Dailey, +1-513-762-1304, Investors: Cindy Homes, +1-513-762-4969; Stayhealthy Media Contact: William A. Pierce, APCO Worldwide, +1-202-659-7931 or +1-301-801-4022 (Cell), wpierce@apcoworldwide.com Web Site: http://www.kroger.com