Tag Archives: clinical trial

bioscience

Pancreatic cancer drug successfully tested by TGen

A clinical trial conducted by researchers at the Virginia G. Piper Cancer Center Clinical Trials, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen), showed that a new drug called MM-398, given in combination with 5-flourouracil (5FU) and leucovorin, produced a significant overall survival rate in patients with advanced, previously-treated pancreatic cancer.

The NAPOLI-1 (NAnoliPOsomaL Irinotecan) Phase 3 study — a final confirmation of a drug’s safety and effectiveness — was conducted among patients with metastatic pancreatic cancer who previously received gemcitibine, which has been the standard-of-care therapy for such patients.

The study, sponsored by Merrimack Pharmaceuticals, evaluated 417 patients enrolled at more than 100 sites in North America, South America, Europe, Asia and Australia, including patients at the Virginia G. Piper Cancer Center at Scottsdale Healthcare. Merrimack expects to submit a New Drug Application this year to the U.S. Food and Drug Administration (FDA) for the MM-398 combination regimen.

“This demonstration of a survival benefit from the MM-398 plus 5-FU and leucovorin combination is particularly important given that we have very few treatment options for patients in this tough clinical setting,” said Dr. Daniel D. Von Hoff, MD, FACP, global principal investigator of the NAPOLI-1 study, Chief Scientific Officer for Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief and Distinguished Professor at TGen. “The results of the NAPOLI-1 study are important because of the critical need to help patients with this devastating illness and move forward towards FDA approval.”

The combination of MM-398 with 5-fluorouracil (5-FU) and leucovorin achieved an overall survival of 6.1 months, a 1.9 month improvement over the 4.2 month survival demonstrated by the control arm of 5-FU and leucovorin alone.

Each year in the U.S., nearly 46,000 people are diagnosed with pancreatic cancer, and more than 39,000 patients die, making it the fourth leading cause of cancer death. Only about 1 in 4 patients survive more than one year after diagnosis, and only 6 percent survivor more than five years.

Symptoms of pancreatic cancer usually do not appear until the cancer is in its late stages, making it difficult to treat. Once the disease spreads to other parts of the body, most patients are not candidates for surgery and receive chemotherapy as their primary treatment.

This study will be presented at the European Society for Medical Oncology World Conference on Gastrointestinal Cancer being held June 25-28 in Barcelona, Spain.

Patients seeking information about research studies may contact the Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare at 480-323-1339 or toll free at 1-877-273-3713 or e-mail: clinicaltrials@shc.org.

DBruggeman

CRA President among life science's most inspiring

Tempe-based Clinical Research Advantage (CRA), the country’s largest wholly owned network of clinical trial sites, announced that the company’s President & Chief Operating Officer,  David M. Bruggeman, has been selected by PharmaVOICE Magazine as one of the 100 most inspiring people in the life sciences industry. Bruggeman, a 30-year healthcare industry veteran, was honored for his vision and innovation in the clinical trials industry.

Since acquiring CRA in 2007, Bruggeman has been the pioneering force behind the development of an integrated platform for clinical research. This platform has allowed CRA to standardize its research procedures and make the trial process safer and more efficient. It has also enabled CRA to expand rapidly – growing from just six sites in Phoenix to more than 60 sites across the country in the past six years.

“David is an inspiring leader who is dedicated to furthering our industry,” said Mark S. Hanley, CRA’s Chief Executive Officer.  “David’s work has improved the quality and efficiency of clinical trials and improved the patient experience. On behalf of the CRA team, I’d like to congratulate David on this well-deserved honor.”

The PharmaVOICE 100 is an annual list of individuals recognized for their positive contributions to the life sciences industry. Nominated by thousands of PharmaVOICE readers, the recipients are selected based on comprehensive essays describing how they have inspired or motivated their colleagues, peers and others; and how they have affected positive change in their organizations or communities. The individuals of the PharmaVOICE 100 represent a broad cross section of industry sectors, including pharmaceutical, biopharmaceutical, biotechnology, contract research, clinical trial, research and development, patient education, patient recruitment, advertising, technology and many others.

DBruggeman

CRA President among life science’s most inspiring

Tempe-based Clinical Research Advantage (CRA), the country’s largest wholly owned network of clinical trial sites, announced that the company’s President & Chief Operating Officer,  David M. Bruggeman, has been selected by PharmaVOICE Magazine as one of the 100 most inspiring people in the life sciences industry. Bruggeman, a 30-year healthcare industry veteran, was honored for his vision and innovation in the clinical trials industry.

Since acquiring CRA in 2007, Bruggeman has been the pioneering force behind the development of an integrated platform for clinical research. This platform has allowed CRA to standardize its research procedures and make the trial process safer and more efficient. It has also enabled CRA to expand rapidly – growing from just six sites in Phoenix to more than 60 sites across the country in the past six years.

“David is an inspiring leader who is dedicated to furthering our industry,” said Mark S. Hanley, CRA’s Chief Executive Officer.  “David’s work has improved the quality and efficiency of clinical trials and improved the patient experience. On behalf of the CRA team, I’d like to congratulate David on this well-deserved honor.”

The PharmaVOICE 100 is an annual list of individuals recognized for their positive contributions to the life sciences industry. Nominated by thousands of PharmaVOICE readers, the recipients are selected based on comprehensive essays describing how they have inspired or motivated their colleagues, peers and others; and how they have affected positive change in their organizations or communities. The individuals of the PharmaVOICE 100 represent a broad cross section of industry sectors, including pharmaceutical, biopharmaceutical, biotechnology, contract research, clinical trial, research and development, patient education, patient recruitment, advertising, technology and many others.

Arizona Heart Walk - AZ Business Magazine January/February 2012

St. Luke¹s adds First Patients in Cardiac Clinical Trial

St. Luke’s Medical Center today announced its chief of cardiology, Richard Heuser, M.D., FACC, has enrolled the first two U.S. patients in the PRESERV clinical trial (Prospective Randomized Evaluation to Study the Effects of Reduced contrast media on the Vitality of the Kidney) sponsored by Osprey Medical Inc.(ASX: OSP).The study utilizes the CINCOR System, a dye reduction and removal system that aims to limit the amount of dye used during a coronary angiogram, a common heart procedure, from reaching the kidneys, thereby reducing the risk of kidney damage.

“We are honored to have Dr. Heuser enroll our first U.S. patients,” said Mike McCormick, president of Osprey Medical. “He is one of the world’s leading cardiologists and we are excited to have his contributions to the PRESERV Trial.

Dye is routinely used to ‘x-ray’ heart tissue during coronary angiography and stenting procedures, but it can cause serious and irreversible damage to the kidneys, known as Contrast Induced Nephropathy (CIN). This damage can be significantly more harmful to those patients at high-risk of CIN due to pre-existing chronic kidney disease, which accounts for 25 percent of all patients undergoing coronary angiography and stenting procedures

“While there is no way to completely prevent dye from reaching the kidneys, the CINCOR System potentially offers patients an advanced level of protection against the damage it can cause,” said Dr. Heuser.

Prevention of CIN in high-risk patients may lead to shorter hospital stays, improved patient outcomes and may ultimately save patient’s lives.

The trial will enroll 600 patients in up to 40 centers around the world. St. Luke’s Medical Center is the only participating hospital in Arizona.

St. Luke’s Medical Center is currently seeking qualified patients to enroll in the clinical trial. Participants are required to partake in a 30-day study and will receive a $25 gift card upon completion. For more information about enrollment, contact Renata Schwartz, RN, at 602-251-8890.

Mark H pics 001

CRA forms alliance with Quintiles

Tempe-based Clinical Research Advantage (CRA), the country’s largest community-based network of clinical trial sites, has entered into a strategic agreement  with Quintiles to facilitate a higher level of clinical trial participation with an emphasis on safety, improved study efficiencies and excellent quality data in medical research. Clinical Research Advantage is the first therapeutically aligned network of Family Medicine community-based sites selected by Quintiles as a strategic alliance.

“It is an honor to be chosen by Quintiles, the world’s largest biopharmaceutical services provider with the highest standards for quality and safety,” said Mark S. Hanley, CRA’s Chief Executive Officer. “The core value and principal purpose of Clinical Research Advantage is to improve the lives of patients through the development of new medical therapies. Working with Quintiles will allow CRA to conduct an increased number of community-based trials with unparalleled accuracy and safety.”

“Clinical Research Advantage impressed us with their high standards for quality, high patient enrolments, and exceptional study start-up abilities,” said Lindy Jones, Senior Vice President, Integrated Site Services, Quintiles. “Many chronic conditions such as diabetes and heart disease are now managed in the community. It is imperative that these patient populations have the opportunity to participate in studies and be a part of the quest to develop new and better medicines for conditions that have a significant impact on both individuals and society.  We are pleased to enter into this relationship with CRA and anticipate that together we will ensure that studies start on the right path.”

The CRA-Quintiles relationship marks a new era in Phase II – IV clinical trials, enabling physicians and clinical researchers to conduct an increased number of trials across a wide range of disease areas. In addition, it will streamline and expedite the process of bringing these potentially life-changing and life-saving drugs to market.
About Clinical Research Advantage

Tempe, Arizona-based Clinical Research Advantage, Inc. (CRA) is a provider of a range of research services to pharmaceutical companies and clinical research organizations. As a leading trial management organization, CRA operates from 38 sites across 17 geographic markets nationwide, helping trial sponsors bring drugs to market more quickly and efficiently. Founded in 1992, CRA has successfully completed more than 1,800 clinical trials on behalf of its clients. For more information, please visit www.crastudies.com.

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Clinical Research Advantage VP earns Silver Stevie

Kim Kundert, RN, BSN, CCRC, has received the 2012 Silver Stevie Award for Female Executive of the Year in the Business Services category. Kundert was honored for her achievements as Vice President of Clinical Operations for Clinical Research Advantage, an integrated network of clinical trial sites.

The Stevie Awards for Women in Business are the world’s top honors for female entrepreneurs, executives, and the organizations they run. All individuals and organizations worldwide are eligible to submit nominations – public and private, for-profit and non-profit, large and small. The 2012 awards received entries from 17 nations and territories.

Stevie Award winners were selected by more than 200 executives worldwide who participated in the judging process this year.

“In 2012, Clinical Research Advantage became the largest integrated site network in the United States, and Kim Kundert has been a driving force behind the company’s rapid growth and expansion. We are thrilled that she has received national recognition for her executive leadership,” said Mark S. Hanley, CEO of Clinical Research Advantage.

This year marked the 9th Annual Celebration of the Stevie Awards for Women in Business. “This year’s Stevie Award-winning women are the most accomplished, impressive group we’ve ever had. Their stories of success will be an inspiration to women around the globe who dream of starting and growing a business and making a difference in the world,” said Michael Gallagher, president and founder of the Stevie Awards.

Barrow Clinical Trial - Down Syndrome Patients

Barrow Launches Novel Clinical Trial For Down Syndrome Patients

Physicians at Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center are conducting a novel research study to evaluate a medication that could improve intellectual function in young adults with Down syndrome. Participants for the clinical trial are currently being recruited.

“To my knowledge, this is the first trial of its kind,” says Benjamin Seltzer, MD, Director of the Center of Alzheimer’s Disease and Cognitive Disorders at Barrow Neurological Institute. “Down syndrome is the most important cause of development delay. Many of the medical problems associated with Down syndrome, such as low thyroid and heart defects, can now be corrected. But, until recently, there has been little hope that we could ever truly improve intellectual function (in Downs people). Now, however, researchers have developed a medication that may have such a benefit. (A study like this has been needed for a long time).”

There are more than 400,000 people living with Down syndrome in the United States. One in every 691 babies is born with Down syndrome.

The clinical trial at Barrow will last about 15 weeks. Participants will be required to take the newly developed medication twice daily and to have periodic blood and memory testing and brain wave examinations. The study is also being conducted at several other research centers in the United States and the United Kingdom.

Participants can be male or female and should be between 18 and 30 years of age. They must be in good general health and have a reliable person who can accompany them to all appointments.

For more information on how to enroll in this study, please call: Catherine Young at 602-406-3719.

For more information on Barrow Neurological Institute, visit their website at thebarrow.org/.