Medical and Health News: Clinical

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Saturday, April 9, 2011

Retina Implant AG Partners With Wills Eye Institute To Bring Artificial Vision Clinical Trials To The United States

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials
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Retina Implant AG, a leading developer of subretinal implants for the visually impaired, announced that they will partner with the Wills Eye Institute in Philadelphia as the lead U.S. clinical trial investigator site. This partnership marks the first time Retina Implant's subretinal implant technology will be utilized in studies by patients who suffer from retinitis pigmentosa in North America.

"The results of the subretinal approach in Europe demonstrate the great potential this implant has to impact dramatically the quality of life for our patients here in the United States," said Dr. Julia A. Haller, ophthalmologist-in-chief, Wills Eye Institute. "Patients involved in previous clinical trials have achieved extraordinary success in their ability to regain useful vision. It is this life-changing success we hope to replicate with our own patients as Wills becomes the first institution in the U.S. to offer Retina Implant's technology."

Retina Implant's subretinal implant technology has been in clinical trials for more than six years in Germany and plans to expand its second human clinical trial into the U.K. this summer. The results of their first human clinical trial proved to be superior to any other company in the retinal implant industry. Moreover, results of Retina Implant's first human clinical trial were published in the prestigious peer-reviewed journal Proceedings of the Royal Society B last November. The results showed placement of the implant below the retina, in the macular region, provided optimum visual results allowing patients to recognize foreign objects and to read letters to form words.

"We are honored to work with one of the foremost eye care centers in the world to bring our product to the United States," said Dr. Walter-G. Wrobel, president and CEO, Retina Implant AG. Reinhard Rubow, executive vice president and CFO, Retina Implant AG adds: "It is our hope that by offering patients in America with this technology that we, with the Wills Eye Institute, will be able to change the lives of those who are currently living in darkness."

Wills Eye Institute was established in 1832 as the nation's first eye care hospital and is recognized as a world-leader in the field of ophthalmology. Wills Eye has been ranked as one of the nation's top three ophthalmology centers by the annual U.S. News & World Report survey since its inception in 1990, and provides a full-range of primary and sub-specialty eye care. Wills Eye is the only center in North America that will conduct this evaluation of artificial vision.

"Wills Eye Institute has a strong tradition of innovation and discovery, providing people who suffer from eye disorders with cutting-edge technology that can assist them in living the best possible life," said Joseph P. Bilson, executive director, Wills Eye Institute. "We're excited to be working with Retina Implant and continue our tradition by bringing this technological advance to people in the United States who have lost their vision due to retinitis pigmentosa."

Source:
Wills Eye Institute
Retina Implant AG

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Wednesday, April 6, 2011

AAP Clinical Report: Children's Eating Disorders On The Rise

Main Category: Eating Disorders
Also Included In: Pediatrics / Children's Health
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In the past decade, a growing number of children and adolescents have been diagnosed with eating disorders. In a new clinical report from the American Academy of Pediatrics (AAP), "Identification and Management of Eating Disorders in Children and Adolescents," published in the December 2010 issue of Pediatrics (published online Nov. 29), it is estimated that 0.5 percent of adolescent girls in the United States have anorexia nervosa, and 1 percent to 2 percent meet criteria for bulimia nervosa.

There is an increasing recognition of eating disorders in males, which now represent up to 10 percent of all cases of eating disorders, as well as in children of younger ages. A recent analysis by the Agency for Healthcare Research and Quality revealed that from 1999 to 2006, hospitalizations for eating disorders in children under 12 years of age increased by 119 percent.

The clinical report suggests pediatricians be familiar with early detection and proper evaluation of patients suspected of having a disorder. Because medical complications of eating disorders can affect any organ system, pediatricians should monitor patients for medical or nutritional problems, and ensure appropriate treatment options including medical care, mental health treatment and nutritional intervention.

Source:
American Academy of Pediatrics

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Sunday, April 3, 2011

Award In Excellence For Clinical Pharmacology Honours Bryan Roth

Main Category: Schizophrenia
Also Included In: Depression; Bipolar; Eating Disorders
Article Date: 25 Mar 2011 - 4:00 PDT window.fbAsyncInit = function() { FB.init({ appId: 'aa16a4bf93f23f07eb33109d5f1134d3', status: true, cookie: true, xfbml: true, channelUrl: 'http://www.medicalnewstoday.com/scripts/facebooklike.html'}); }; (function() { var e = document.createElement('script'); e.async = true; e.src = document.location.protocol + '//connect.facebook.net/en_US/all.js'; document.getElementById('fb-root').appendChild(e); }());

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Bryan L. Roth, PhD, the Michael J. Hooker Distinguished Professor of Pharmacology in the University of North Carolina at Chapel Hill School of Medicine, has received the PhRMA Foundation Award in Excellence in Pharmacology/Toxicology.

Roth is also professor in the departments of pharmacology, medicinal chemistry and natural products and he holds the Michael Hooker Chair of Protein Therapeutics and Translational Proteomics.

His work in pharmacology and drug discovery has earned him numerous patents and he has published nearly 300 articles in, among many other publications, Science, Nature, Cell and the New England Journal of Medicine. He has also trained dozens of doctoral and post-doctoral students who have also become leaders in their field.

Much of Roth's research focuses on trying to understand how central nervous system drugs affect the brain's neurons. The goal is to investigate existing treatments in order to find new treatments and mitigate side effects, particularly for such problems as schizophrenia, depression, bipolar disorder and eating disorders.

"We really don't understand how most drugs currently used in brain disorders work," he explained. "If we can uncover how they exert their therapeutic actions, we hope to find drugs that are more effective. Additionally, if we can understand the side effects of current drugs, we'll know what molecular targets we have to avoid in making new drugs so they don't have the side effects."

Essentially, the work identifies both good targets for drug development, and bad targets to be avoided. In one application of the technique, Roth's lab identified potentially safe and effective compounds for treating obesity. Those compounds have been out-licensed to biotech companies for commercial development.

And In one of his most important research projects, Dr. Roth and his team at UNC, along with scientists at the University of California, San Francisco, developed and validated a computer model that can allow researchers to predict likely side effects before a drug is even put into clinical testing. The method compares the structures of all known drugs for various disease targets to their naturally-occurring binding partners. That comparison has revealed interactions between drugs and their targets that could not be predicted simply by studying their chemical structures.

A native of Butte, Montana, Roth graduated from Carroll College in Helena in 1977 with a degree in biology and chemistry. He subsequently earned his combined MD/PhD in Biochemistry in 1983 from St. Louis University School of Medicine.

He completed an internship in psychiatry at the National Naval Medical Center in Bethesda, Md. in 1984, and from 1983-1986 worked at the National Institute of Mental Health. During much of that period, he also worked at the Naval Medical Research Institute in Bethesda, first as a principal investigator and later as assistant division head of the institute's surgical research division.

In 1991 Dr. Roth concluded his residency in psychiatry at Stanford University Medical School, where he was also a Dana Foundation Fellow in Neurosciences in the Nancy Pritzker Laboratory of Molecular and Developmental Neurobiology. That year, he also received his first PhRMA Foundation grant.

After completing his studies at Stanford he held appointments at Case Western Reserve University School of Medicine for more than a decade in Departments of Psychiatry, and Biochemistry, ultimately becoming a Full Professor of Biochemistry in 2003. During much of that time he was on the faculty of Case Western Reserve University, where he specialized in the treatment of schizophrenia and, for a time, directed the Schizophrenia Research Ward at University Hospitals of Cleveland.

The annual Award in Excellence honors researchers who received PhRMA Foundation grants early in their careers and then distinguished themselves through outstanding scientific and/or academic achievements.

"This award is wonderful for me and for my lab. Essentially, the PhRMA Foundation makes a bet on young investigators, and no one knows for years whether it was a good bet or not. I am happy I was able to find success and, hopefully, will continue to find it for many years."

The Award in Excellence will be presented April 9 at a meeting of the American Society for Pharmacology and Experimental Therapeutics.

Source:
Les Lang
University of North Carolina School of Medicine

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Monday, March 28, 2011

Clinical Cancer Research Programs Merge To Accelerate Research

Main Category: Cancer / Oncology
Also Included In: Radiology / Nuclear Medicine; Genetics
Article Date: 21 Mar 2011 - 1:00 PDT window.fbAsyncInit = function() { FB.init({ appId: 'aa16a4bf93f23f07eb33109d5f1134d3', status: true, cookie: true, xfbml: true, channelUrl: 'http://www.medicalnewstoday.com/scripts/facebooklike.html'}); }; (function() { var e = document.createElement('script'); e.async = true; e.src = document.location.protocol + '//connect.facebook.net/en_US/all.js'; document.getElementById('fb-root').appendChild(e); }());

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The American College of Radiology's Imaging Network (ACRIN) and the Eastern Cooperative Oncology Group (ECOG), National Cancer Institute (NCI) Clinical Trials Cooperative Group members, have announced their intent to merge their clinical cancer research programs.

The groups plan to form an alliance that combines their complementary strengths. The new organization will include three areas of research emphasis: early detection and diagnosis of cancer; biomarker-driven Phase II and Phase III therapeutic studies for multiple cancer types and stages; and genetic, molecular and imaging marker research to predict and monitor treatment response.

As leading research organizations, ECOG and ACRIN's individual programs have significantly contributed to improved clinical care. The new alliance will bring together the organizations' unique capabilities to build a program with expanded scientific scope and depth of expertise. ECOG has strengths in performing large-scale trials with molecular endpoints in major diseases; the results of these studies have changed the treatment of cancer patients, and helped to individualize that therapy. ACRIN's clinical trials encompass the full range of medical imaging research: from landmark cancer screening trials to early phase trials evaluating imaging biomarkers and novel imaging technologies. While maintaining these areas of separate expertise, the alliance will press the tailoring of therapy to the individual patient's tumor, and accelerate the integration of biological advances into clinical practice.

"This partnership offers the research community a new sphere of engagement," says Robert L. Comis, MD, Chair of ECOG. "It will greatly enhance our position in the public and private sectors to perform biomarker-driven studies and develop more innovative clinical trial designs. ACRIN has an exceptional imaging research program and IT infrastructure which can be applied to compile and store not only radiologic images, but also, relevant laboratory based images. Our modality and disease committees will have the opportunity to become involved in the development of cutting edge early detection and diagnostic studies, and ACRIN investigators will benefit from being fully integrated into our therapeutically oriented programs."

"We are excited by the ECOG partnership opportunity to develop a unique multidisciplinary organization positioned to study the entire cancer care path from early detection through management of advanced disease," says Mitchell D. Schnall, MD, PhD, ACRIN Network Chair. "We will leverage the complementary scientific expertise of each group to develop multidisciplinary scientific committees to address each of the three emphasis areas for which there will be immediate opportunities for interaction and collaboration. The integration of ECOG and ACRIN patient advocacy and clinical research associate committees will bring together an impressive knowledge base representing the patient perspective and participant recruitment best practices - a significant support for getting the research done."

"Clinical research has been an important component of the American College of Radiology (ACR) for over 40 years, comments Harvey L. Neiman, MD, FACR, the ACR's chief executive officer. "I commend the decision to bring together the extensive resources of ACRIN and ECOG to carry out clinical research that combined has even greater potential to bring forth new scientific discoveries to detect cancer earlier and to improve the care and quality of life of cancer patients."

Transition planning is underway, and group leaders are developing the business, administrative and scientific structures. The new organization will sustain its research portfolio with public and private support. Relative to public funding, the NCI announced last November that it will reorganize its Cooperative Group program to support up to four adult cooperative groups, and will issue a new Funding Opportunity Announcement (FOA) in Spring 2012; the new organization will respond on behalf of ECOG and ACRIN..

Source:
Shawn Farley
American College of Radiology

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Friday, March 25, 2011

Clinical Study Demonstrates LDL Particles Are More Strongly Associated With Cardiovascular Events Than LDL Cholesterol

Main Category: Cholesterol
Also Included In: Cardiovascular / Cardiology
Article Date: 21 Mar 2011 - 4:00 PDT window.fbAsyncInit = function() { FB.init({ appId: 'aa16a4bf93f23f07eb33109d5f1134d3', status: true, cookie: true, xfbml: true, channelUrl: 'http://www.medicalnewstoday.com/scripts/facebooklike.html'}); }; (function() { var e = document.createElement('script'); e.async = true; e.src = document.location.protocol + '//connect.facebook.net/en_US/all.js'; document.getElementById('fb-root').appendChild(e); }());

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LipoScience, Inc., a highly innovative diagnostic company that is advancing patient care by developing high value proprietary blood tests using nuclear magnetic resonance (NMR) technology, announced publication of a clinical study in the Journal of Clinical Lipidology demonstrating that in many people, low density lipoprotein (LDL) cholesterol ("bad" cholesterol) is a less accurate predictor of cardiovascular disease (CVD) events than LDL particle number.

"Additional studies should be conducted to estimate the potential value of this information for the prevention of cardiovascular disease in the general population."

LDL cholesterol is transported in spherical LDL particles. High levels of LDL particles are a proven cause of plaque buildup in the arteries, which in turn leads to heart attacks and other CVD events. Clinicians historically have used the LDL cholesterol level, the amount of cholesterol carried within LDL particles, to determine how much treatment, if any, a patient needs. Controlling LDL levels with diet, exercise and LDL-lowering drugs is thus a primary focus of CVD prevention efforts.

"This paper provides additional evidence that measurement of lipoprotein particles in clinical practice might lead to better risk management and prevention of cardiovascular disease," said David C. Goff, Jr., M.D., Ph.D., chair of the Department of Epidemiology and Prevention at Wake Forest University Baptist Medical Center and an investigator in the study. "Additional studies should be conducted to estimate the potential value of this information for the prevention of cardiovascular disease in the general population.

"In many patients, the standard cholesterol test may not be sufficient to adequately manage LDL levels. Patients who achieve recommended LDL-C goals may not have achieved correspondingly low LDL-P levels and as a consequence, may need further LDL lowering," said Dr. Goff.

Researchers analyzed blood samples obtained at study onset from 5,598 middle-aged men and women free of cardiovascular disease who participated in the Multi-Ethnic Study of Atherosclerosis (MESA), a prospective observational study initiated and overseen by the National Heart, Lung and Blood Institute. Participants were followed for a mean of 5.5 years for incident CVD events - including heart attack, coronary heart disease death, angina, stroke, stroke death or other artherosclerotic or CVD death.

Because the cholesterol content of LDL particles varies from person to person, there may be disagreement between LDL cholesterol and LDL particle levels. Of 319 total CVD events recorded, 159 occurred in persons with LDL cholesterol and LDL particle numbers that disagreed. The CVD risk of these individuals tracked with LDL particle number regardless of levels of LDL cholesterol. LDL particle levels were measured using LipoScience's NMR LipoProfile® test, a laboratory test that utilizes nuclear magnetic resonance (NMR) spectroscopy to measure LDL and other lipoprotein particles. LDL particle information can help clinicians personalize and refine LDL treatment decisions, particularly to minimize residual risk in patients with low LDL cholesterol levels.

Source:
LipoScience, Inc.

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Tuesday, March 22, 2011

Curis Announces Positive Results In Genentech Pivotal Phase II Clinical Trial Of GDC-0449 In Advanced Basal Cell Carcinoma

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
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Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced a positive outcome from a pivotal Phase II clinical trial conducted by Roche and Genentech, Curis' collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class hedgehog pathway inhibitor, in patients with advanced basal cell carcinoma (BCC). Genentech informed Curis that the study met its primary endpoint of achieving a target overall response rate, showing that GDC-0449 shrank advanced BCC tumors in a pre-defined percentage of people in the study. A preliminary safety assessment showed the most common adverse events were consistent with previous experience with vismodegib. A detailed safety assessment is ongoing. Roche has indicated that it anticipates making at least one regulatory submission in 2011 to seek approval to commercialize GDC-0449.

Genentech plans to submit the data from the clinical trial for presentation at a future medical meeting.

Roche also informed Curis that GDC-0449 (also known as RG3616) now has a generic name approved by the World Health Organization, vismodegib (pronounced vis-mo-DE-jib).

"We are extremely pleased by the highly encouraging outcome of this study, particularly since there is currently no standard of care for patients with this serious disease," said Dan Passeri, Curis President and Chief Executive Officer. "We look forward to Genentech's presentation of the study data in more detail in the near future, and to its planned regulatory submissions for vismodegib."

About the Pivotal Phase II Trial (ERIVANCE BCC/SHH4476g)

ERIVANCE BCC is an international, single-arm, multi-center, two-cohort, open-label Phase II study that enrolled 104 patients with advanced BCC, including metastatic and/or locally advanced BCC, defined as patients whose lesions are not appropriate for surgery, or for whom surgery would result in substantial deformity. Study participants received 150 mg vismodegib once daily until disease progression. The primary endpoint of the study was overall response rate (tumor shrinkage) as assessed by independent reviewers. Secondary endpoints of the study included overall response rate as assessed by study investigators, duration of response, progression-free survival, overall survival and the safety profile. A preliminary safety assessment showed the most common adverse events were muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite and diarrhea. Serious adverse events were observed, including fatal events. The deaths are being further evaluated, but do not appear to be related to vismodegib.

About Basal Cell Carcinoma

According to the American Cancer Society, BCC is the most common type of skin cancer and accounts for approximately 80 percent of all diagnosed skin cancers. The disease is generally considered curable when the cancer is restricted to a small area of the skin. However, in a small group of people, if the disease is left untreated or does not respond to treatment, the cancer may advance further into the skin, bones or other tissues. In rare cases, BCC may advance or spread to other parts of the body, at which point the disease can become difficult to treat and life-threatening.

About Vismodegib and the Hedgehog Pathway

Vismodegib is designed to selectively inhibit signaling in the Hedgehog pathway by targeting a protein called Smoothened. The Hedgehog signaling pathway plays an important role in regulating proper growth and development in the early stages of life and becomes less active in adults. However, mutations in the pathway that reactivate Hedgehog signaling are seen in several different types of cancer. Abnormal signaling in the Hedgehog pathway is implicated in the majority of BCC cases.

Genentech is also evaluating vismodegib in a Phase II trial in people with operable forms of BCC, which opened in October 2010. Additionally, vismodegib is being evaluated by third-party investigators in a number of other cancers and in people with BCC who have Gorlin syndrome. Gorlin syndrome is a condition that affects many areas of the body and increases the risk of developing BCC.

Source:
Curis, Inc.

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