Health/Medical: Landmark study aims to improve osteoporosis care standards worldwide

Istanbul, (ANTARA News/PRNewswire-AsiaNet) - Nearly 60,000 women aged 55 years and older have enrolled in a landmark, multi-national study that will focus on the management of osteoporosis across the globe.

Launch of the Global Longitudinal Registry of Osteoporosis in Women (GLOW) was announced today at ECCEO 8 (Eighth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis) in Istanbul, Turkey. This groundbreaking observational study (registry) in osteoporosis aims to gain insights to improve the standard of care for postmenopausal women at risk of osteoporosis.

"We know that there are patients at high risk for osteoporosis, sometimes already having suffered a broken bone, who aren't getting diagnosed and treated. We have to figure out why not," said Dr. Robert Lindsay, GLOW Executive Committee Co-Chair and Chief of Internal Medicine at Helen Hayes Hospital, West Haverstraw, NY. "Globally we have an aging female population that wants to maintain independence and vitality. We can help by finding the key to improving diagnosis and treatment of this debilitating disease."

GLOW will monitor tens of thousands of older women who have visited a primary care physician in the past two years. Since patient recruitment for GLOW is not linked to osteoporosis diagnosis and does not alter physician practice, the study provides a good representation of "typical" older women and the bone health care they receive in the real world. Women are participating from 17 cities in 10 countries on 3 continents.

"We want to understand regional differences in physician and patient behavior and how that impacts patient outcomes," said Professor Pierre Delmas, GLOW Executive Committee Co-Chair and Professor of Medicine and Rheumatology, Universite Claude Bernard, Lyon, France. "Hopefully, armed with that knowledge we will be able to recommend best practices and improve the management of osteoporosis worldwide."

GLOW is being conducted by The Center for Outcomes Research (COR), University of Massachusetts Medical School (UMMS), with the support of an unrestricted research grant from The Alliance for Better Bone Health. The Alliance for Better Bone Health is a collaboration between sanofi-aventis and Procter & Gamble Pharmaceuticals.

"We are grateful for the commitment of the sponsors and scientific advisors to the GLOW project. We anticipate that these data will provide important information to improve the quality of lives of women at risk for osteoporotic fractures," said Dr. Fred Anderson, Director of the Center for Outcomes Research and research professor of surgery and medicine at UMMS. "This pioneering initiative will be the first comprehensive multi-national look into the relationship between risk factors, patient outcomes and treatment patterns for osteoporosis."

Milestone data from GLOW will be communicated on an ongoing basis at international medical conferences and through peer-reviewed publications. For more information on GLOW, please visit: http://www.outcomes.org/glow

About GLOW

GLOW is a prospective, longitudinal, observational study of women over 55 years of age who visited a primary care physician during the two years prior to the study. Women were recruited through 700 primary care physicians in 17 cities in North America, Europe, and Australia. GLOW will gather information on osteoporosis risk factors, treatment approaches, patient behavior, and fracture outcomes with an annual patient survey over a 5 year period.

GLOW study sites are the following:
Lyon, France
Paris, France
Leuven, Belgium
Amsterdam, Netherlands
Barcelona, Spain
Essen, Germany
Verona, Italy
Southampton, UK
West Haverstraw, NY USA
Worcester, MA USA
Pittsburgh, PA USA
Seattle, WA USA
Cincinnati, OH USA
Los Angeles, CA USA
Birmingham, AL USA
Hamilton, Ontario Canada
Sydney, Australia

About osteoporosis

Osteoporosis-related fragility fractures are an international public health problem responsible for increased mortality, functional impairment and added health care costs. Estimates are that between 40 and 50 percent of white women above the age of 50 in North America, Europe and Australia will incur an osteoporosis-related fracture in their lifetime. Although their rates are lower, non-white women and men are also susceptible. Because the likelihood of fragility fractures increases dramatically with age, fracture numbers are projected to rise as the population ages.

About the Center for Outcomes Research (COR)

COR is based at the University of Massachusetts, Worcester, MA, USA. The mission of COR is to collect and evaluate data that reflect real world practices and outcomes and to provide physicians with confidential reports that allow comparison of their practices to evidence based performance standards. For more information, please visit: http://www.outcomes.org

SOURCE: University of Massachusetts
NOTE TO EDITORS:
Spokespeople available for comment:
Dr. Robert Lindsay
Executive committee co-chair, GLOW
Chief of Internal Medicine
at Helen Hayes Hospital, West Haverstraw, NY
Professor Pierre Delmas
Executive committee co-chair, GLOW
Professor of medicine and rheumatology,
Universite Claude Bernard, Lyon, France

CONTACT: Helen Crow,
+44-0-7787-533-023,
helen.crow@ketchum.com, or
Peter Impey,
+44-0-7976-734-493,
peter.impey@ketchum.com,
both of Ketchum,
for University of Massachusetts
Web site: http://www.outcomes-umassmed.org
http://www.outcomes.org/glow

COPYRIGHT © 2008

Final data from the SEISMIC Trial suggest safety, efficacy

Chicago, Illinois, (ANTARA News/PRNewswire-AsiaNet) - Final six-month, follow-up patient data presented yesterday during the late-breaking clinical trial sessions at the American College of Cardiology, suggest MyoCell(R) myoblast clinical cell therapy is a safe and potentially effective alternative treatment to standard medical therapy alone for improving heart function among patients with previously implanted cardiac devices who are experiencing congestive heart failure.

The findings from the SEISMIC(1) Trial, a 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe, evaluated MyoCell myoblast clinical cell therapy delivered via the MyoCath(R), endoventricular needle-injection catheter in patients previously fitted with implanted cardiac defibrillators(ICDs), receiving standard medical therapy and who are experiencing congestive heart failure.

On admission to the trial, patients were randomized on a two-to-one ratio into the treatment versus control groups with 26 patients receiving MyoCell therapy and 14 patients in the control group. All patients were experiencing congestive heart failure and were previously fitted with ICDs and receiving standard medical therapy.

Both the MyoCell biologic therapy and the MyoCath needle-injection catheter, developed by Bioheart, Inc., are currently being studied as investigational products.

"The results from the SEISMIC trial are encouraging," said Prof. Patrick W. Serruys, MD, PhD, Principal Investigator and Chief, Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center - Rotterdam, the Netherlands. "While the study was specifically designed to show safety, the findings also suggest positive trends in clinical benefits when evaluating the treated group versus the control group at six months."

Patients in both groups were evaluated at three- and six-month intervals using a variety of tests, including digital imaging and standard quality of life measurement such as the six-minute walking test, New York Heart Association (NYHA) heart failure classification and Minnesota Living with Heart (MLHF) questionnaire.

Final six-month results observed in the SEISMIC Trial include:

-- 84 per cent of treated patients experienced improved or unchanged six- minute walking test scores compared to 16 per cent of the control group - 69 per cent of the control group's results worsened, versus only 16 per cent of the treated group

-- 94 per cent of treated patients experienced improved or unchanged NYHA classification compared to 58 per cent of the control group - 42 per cent of the control group's results worsened, versus only 6 per cent of the treated group Prof.

Serruys also noted that reports of arrhythmia among the patients evaluated in SEISMIC, both in terms of total number of episodes as well as timing of episodes, were no different between the treatment and control arms in the study.

This suggests that MyoCell is not associated with a higher prevalence of arrhythmias; rather, that arrhythmias are an expected occurrence for this subset of heart failure
patients.

"These data support the need for a randomized, double-blind, placebo-controlled study involving the MyoCell technology," said Prof. Serruys. "We look forward to applying our learning from this trial to the larger, more comprehensive MARVEL(2) Trial currently underway in the U.S. and Europe." The MARVEL Trial, a randomized, double-blind, placebo-controlled, multi-center Phase II/III Trial involving 330 patients in North America and Europe, is the largest trial of its kind to date. Enrollment in the MARVEL Trial began in October 2007, targeting patients who fall into Class II or III heart failure.

The MARVEL Trial will further study the safety and efficacy of the minimally invasive MyoCell autologous stem-cell therapy in the treatment of congestive heart failure delivered via a MyoStar(TM) injection catheter(3), in combination with the NOGA(R) XP Cardiac Navigation System. The Principal Investigator for the MARVEL Trial is Warren Sherman, MD, Director, Cardiac Cell-based Endovascular Therapies, Columbia University Medical Center, New York.

ABOUT MYOCELL CLINICAL CELL THERAPY

MyoCell clinical cell therapy, developed by Bioheart, Inc., is currently being studied as an investigational product in Europe and the U.S. MyoCell clinical cell therapy is intended to be used to improve cardiac function months or even years after a patient has suffered severe heart damage due to a heart attack.

The procedure involves a physician removing a small amount of muscle obtained from the patient's thigh. From this muscle specimen, autologous myoblasts (muscle stem cells) are then isolated, grown using Bioheart's proprietary cell-culturing process, and injected directly into the scar tissue of the patient's heart.

The myoblast cells are delivered via an endoventricular needle-injection catheter during a minimally invasive procedure performed by an interventional cardiologist or vascular surgeon. The myoblast-based muscle formation in the newly populated regions of scar tissue are intended to improve cardiac function by helping the heart muscle beat more efficiently.

ABOUT HEART DISEASE

Approximately nine million European patients and 5.2 million Americans(4) suffer from congestive heart failure, a progressively degenerative condition in which the heart is unable to adequately pump blood throughout the body resulting in fluid accumulation in the lungs, kidneys, and other body tissues.

Patients suffering from this disease fatigue easily, and become increasingly less capable of normal activity as they progress through the various stages of the disease. Current standard of care typically involves drug therapy and/or the implantation of a pacemaker and/or defibrillator device to regulate heart function.

ABOUT BIOHEART, INC.

Bioheart, Inc. is a biotechnology company focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage.

Its lead product candidate, MyoCell, is an innovative clinical cell therapy designed to populate regions of scar tissue within a patient's heart with autologous muscle cells, or cells from the patient's body, for the purpose of improving cardiac function in chronic heart failure patients. The company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose cell treatment for acute heart damage, and MyoCell SDF-1, a therapy utilizing autologous cells genetically modified to express additional growth factors.

FOOTNOTES

(1) SEISMIC: Safety and Effects of Implanted (Autologous) Skeletal Myoblasts (MyoCell(R)) using an Injection Catheter

(2) MARVEL: A Phase II/III, Double-Blind, Randomized, Placebo-Controlled Multi-center study to Assess the Safety and Cardiovascular Effects of MyoCell Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post-Myocardial Infarction(s)

(3) The MYOSTAR(TM) Injection Catheter is not available for sale in the U.S. It is in use in IND investigations

(4) Heart Association Heart Disease Statistics - 2007 Update MyoCell and MyoCell SDF-1 are trademarks of Bioheart, Inc.

MyoStar and NOGA XP are trademarks of Cordis Corporation, a Johnson & Johnson company For more information, visit http://www.bioheartinc.com

SOURCE: Bioheart, Inc.
CONTACT: Marty Schildhouse, +1-305-606-3577, or Janice
Gilyard, +1-908-276-0777, The Storch-Murphy Group,
or Investor Relations, Joe Diaz of Lytham Partners, LLC,
+1-602-889-9660, for Bioheart, Inc.
Web site: http://www.bioheartinc.com

COPYRIGHT © 2008

DARA BioSciences, Inc. announces appointment of new director to board

Raleigh, North Carolina (ANTARA News/PRNewswire-AsiaNet) - DARA BioSciences(TM) (Nasdaq: DARA) announced today the appointment of Haywood D. Cochrane, Jr. to the Board of Directors.

Mr Cochrane was appointed to fill a Board vacancy and will serve on the Company's Audit and Compensation Committees. The appointment was effective February 21, 2008.

In making the announcement DARA's Board Chairman, Richard Franco, Sr., commented, "We are pleased that Haywood has joined us as a Director. His vast knowledge and successful experience in the healthcare industry will further strengthen DARA's already skilled Board."

Mr Cochrane is currently Vice Chairman and a Director of I-trax, Inc.

(Amex: DMX), a publicly traded, total population health management and productivity company. Mr Cochrane has previously served as a Director of seven other publicly-traded companies.

About DARA BioSciences, Inc.

DARA BioSciences(TM), Inc. ("DARA") is a Raleigh, North Carolina-based development-stage pharmaceutical company that acquires promising therapeutic molecules and medical technologies directly or through investment in established companies.

DARA focuses its therapeutic development efforts on small molecules from late preclinical development through phase 2 clinical trials. DARA is developing a portfolio of therapeutic candidates for neuropathic pain, metabolic diseases including type 2 diabetes, dyslipidemia and dermatological disorders. DARA has licensed promising drug development candidates from Kirin Pharmaceuticals of Japan, Bayer Pharmaceuticals Corporation, Massachusetts General Hospital and Nuada LLC.

For more information please contact the Company at 919-872-5578 or visit our web site at www.darabio.com

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934 as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected.

Those factors include risks and uncertainties relating to the company's ability to develop and bring new products to market as anticipated, the current regulatory environment in which the company develops and sells its products, the market acceptance of those products, dependence on partner, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property, the intellectual property of others and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission. Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov.

DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.

SOURCE: DARA BioSciences, Inc.
CONTACT: John C. Thomas, Jr., Chief Financial Officer,
+1-919-872-5578, or Lynn H. Morris, Sr. Manager, Investor
Relations & Corporate Operations, +1-919-872-5578, both of DARA
BioSciences, Inc.
Web site: http://www.darabio.com

COPYRIGHT © 2008 - ANTARANEWS

Many More Patients Can Now Benefit from Avastin`s Proven Survival Benefits

Avastin Receives Broad Label Extension in Europe for the Treatment of Patients with Metastatic Colorectal Cancer

Basel (ANTARA/PRNewswire-AsiaNet) - Roche announced today that the European Commission (EC) has given its approval for the significantly wider use of its anti-angiogenic agent Avastin(bevacizumab) in patients suffering from metastatic colorectal cancer.

This new broader label will now allow Avastin to be used in combination with any chemotherapy, including Roche's oral chemotherapy Xeloda (capecitabine)*, for 1st and later treatment lines in patients with metastatic colorectal cancer. This news means that virtually all patients with metastatic colorectal cancer now have access to Avastin's proven survival benefits. It is estimated that more than 400,000 people in Europe will be diagnosed with colorectal cancer in 2008.(1)

The Avastin approval follows the European Committee for Medicinal Products for Human Use (CHMP) positive recommendations for the extended use of both Avastin and Xeloda in December 2007. *The final EC decision on Xeloda for its extended use is expected imminently.

The new Avastin label will allow it to be used in combination with every standard fluoropyrimidine based chemotherapy and also allows for combinations with Xeloda or oxaliplatin. Avastin formerly could only be used in combination with IV 5-FU or IV 5-FU/irinotecan-based chemotherapy regimen (2) where it had demonstrated an impressive survival extension of nearly 5 months. Physicians now have the flexibility to use Avastin with a broad variety of standard chemotherapy of their choice in any line of metastatic colorectal cancer.

"This is a major turning point in the treatment of metastatic colorectal cancer patients," said Professor Alberto Sobrero, Head of Medical Oncology, Hospital San Martino, Genoa, Italy. "This approval means that many more patients can benefit from Avastin's significant survival benefits."

The approval of this broad label is based on the results of two large international phase III pivotal studies (NO16966 and E3200).

About the Phase III studies that formed the basis of the approval

Note: Progression-free survival is a measure of the time patients live without their disease advancing.

NO16966 study
NO16966 is a large, international phase III trial which recruited 2,034 patients. It was originally planned to compare XELOX vs FOLFOX as first-line treatment in metastatic colorectal cancer. After release of the pivotal Avastin data in colorectal cancer in 2003, the protocol was amended to investigate using a 2 by 2 factorial design: FOLFOX/XELOX + placebo vs FOLFOX/XELOX + Avastin.

The primary objective was to answer two questions: 1) whether the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of Avastin to chemotherapy improved progression-free survival compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile. Results of the study showed:

-- The addition of Avastin to chemotherapy (XELOX or FOLFOX-4) significantly improved progression-free survival by 20% compared with chemotherapy alone.
-- In patients that received treatment until disease progression, the benefit was even greater, and adding Avastin to chemotherapy improved progression-free survival by 58%.
-- The chemotherapy combination XELOX is as effective in terms of progression-free survival as FOLFOX.

E3200 study
The E3200 study is a randomized, controlled, multi-center phase III trial of 829 patients with advanced or metastatic colorectal cancer who had received previous treatment with irinotecan and 5-FU as initial therapy for metastatic disease or as adjuvant therapy. The study showed that patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 25 percent reduction in the risk of death (based on a hazard ratio of 0.75), the primary endpoint, which is equivalent to a 33 percent improvement in overall survival, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 12.9 months, compared to 10.8 months for those receiving FOLFOX4 alone.

Additional information
-- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
-- Roche Health Kiosk, Cancer: http://www.health-kiosk.ch/start_krebs
-- Avastin: http://www.avastin-info.com

To access video clips about Avastin and Xeloda, in broadcast standard, free of charge, please go to: http://www.thenewsmarket.com

References
(1) Ferlay J, AutierP et al. Annals of Oncology 18: 581-592, 2007.
(2) Hurwitz H, Fehrenbacher L, Novotny W et al. New England Journal
of Medicine 2004; 350(23): 2335-42.

SOURCE: Roche

CONTACT: Erica Bersin of Roche,
+41-61-688-2164,
Erica.Bersin@Roche.com; or

Dominic Elliston of Galliard Healthcare,
+44-207-663-2266,
Delliston@galliardhealth.com

Web site: http://www.avastin-info.com
http://www.health-kiosk.ch/start_krebs
http://www.thenewsmarket.com

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Quintiles names Head of Strategic Research, Medical Services

Research Triangle Park, North Carolina (ANTARA News/PRNewswire-AsiaNet) - Quintiles Transnational Corp. today announced the appointment of Dipti Amin, M.D., as Senior Vice President of Strategic Research and Safety Services (SRS) and Medical and Regulatory Services, effective immediately. She will report to Jeff Thomis, President, Global Clinical Development Services.

Most recently, Amin served as Senior Vice President, Global Medical Services, Regulatory Affairs and Medical Writing, and Strategic Drug Development Unit. A long-time Quintiles employee, Amin is an industry veteran with extensive experience in a variety of industry-related disciplines, including: drug development, clinical operations, Phase I, data management, biostatistics, medical writing, pharmacovigilance and regulatory affairs.

"Combining SRS with Medical and Scientific Services and Regulatory Affairs under Dipti's leadership will enable us to have greater strategic expertise in this growing market and maintain our leadership position in the safety environment," Thomis said.

About Strategic Research and Safety Services

The Strategic Research and Safety Services unit has specialist expertise in conducting the full spectrum of late phase and safety studies and advises pharmaceutical customers on drug development with the goal of maximizing medical benefit and minimizing the risk of therapies for patients.

About Quintiles

Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, financial partnering and commercialization for the biotechnology and healthcare industries. With about 20,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry.
For more information, please visit the company's Web site at www.qtrn.com

SOURCE: Quintiles Transnational Corp.
CONTACT: Mari Mansfield, Media Relations of Quintiles
Transnational Corp., +1-919-998-2639, mobile, +1-919-259-3298,
mari.mansfield@quintiles.com
Web site: http://www.qtrn.com

COPYRIGHT © 2008 - ANTARANEWS

Varian Medical Systems acquires Pan-Pacific Enterprises

Varian Medical Systems Acquires Pan-Pacific Enterprises for Marketing, Sales and Distribution of X-Ray Imaging Products in China

Palo Alto, California (ANTARA News/PRNewswire-AsiaNet) - Varian Medical Systems, Inc., (NYSE: VAR) today announced it has completed the acquisition of Pan-Pacific Enterprises, Inc., the largest independent distributor of medical X-ray tubes in China, for the purpose of marketing, sales, and distribution of Varian X-ray imaging products in China.

Varian is acquiring the privately held business for approximately $2 million in cash plus an additional amount based on achievement of specified milestones. Pan-Pacific has been an independent distributor of imaging components, including Varian X-ray tubes, in China since 1991.

"This acquisition significantly enhances the Varian sales channel for X-ray tubes and flat panel image detectors in China," said Bob Kluge, President of Varian Medical Systems' X-Ray Products business.

"We intend to grow our X-Ray Products business in China and the experienced Pan-Pacific team will be instrumental in helping us achieve that objective. Our business specializes in delivering cost competitive, high performance components for X-ray imaging and they are well-suited to serve the growing market for high-quality imaging products in China."

Pan-Pacific Enterprises, which has approximately 30 employees working at facilities in Beijing and Shanghai, will operate within Varian's X-Ray Products business segment. Details of the financial transaction are not being disclosed, but Varian expects that Pan Pacific acquisition will be about neutral to earnings per diluted share in fiscal 2008.

Varian Medical Systems, Inc., of Palo Alto, California, is the world's leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy.

The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. Varian is a premier supplier of tubes and digital detectors for X-ray imaging in medical, scientific, and industrial applications and also supplies X-ray imaging products for cargo screening and industrial inspection.

Varian Medical Systems employs approximately 4,500 people who are located at manufacturing sites in North America, Europe, and China, and in its 56 sales and support offices around the world.

Forward Looking Statements: Except for historical information, this news release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements concerning customer demand and acceptance of products or technology for X-ray imaging, and the outlook for Varian's orders, sales, backlog, or earnings growth; future financial results and any statements using the terms "will," "intend," "well-suited to serve," "expects," or similar statements are forward-looking statements that involve risks and uncertainties that could cause Varian's actual results to differ materially from those anticipated.

Such risks and uncertainties include the ability to integrate the operations and products of Pan-Pacific Enterprises into Varian, the ability to retain the services of key Pan-Pacific personnel; demand for Varian's X-ray imaging products; the impact of competitive products and pricing; Varian's ability to maintain or increase operating margins; Varian's ability to protect its intellectual property; the risk of operations interruptions due to events beyond Varian's control; and the other risks listed from time to time in Varian's filings with the Securities and Exchange Commission.

We assume no obligation to update or revise the forward-looking statements in this release because of new information, future events, or otherwise.

FOR INFORMATION CONTACT:
Varian Medical Systems Spencer Sias (650)424-5782
SOURCE: Varian Medical Systems, Inc.
CONTACT: Spencer Sias of Varian Medical Systems, +1-650-424-5782
Web site: http://www.varian.com

COPYRIGHT © 2008 - ANTARANEWS