April 24, 2012

By:  Ilya Petrou, M.D.

Kissimmee, Fla. — An aesthetic device that delivers bipolar radiofrequency (RF) energy via microneedling appears to achieve skin tightening, lifting and volumization that can be measured objectively through the comparison of pre- and postprocedure 3-D images, said Lori Brightman, M.D., at the 2012 annual meeting of the American Society for Laser Medicine and Surgery.

Evolastin (Syneron/Candela) is an aesthetic device that delivers controlled fractionated bipolar RF energy directly into the deep dermis via microneedling, resulting in neocollagenesis, neoelastinogenesis and hyaluronic acid formation in the targeted skin, says Dr. Brightman, a board-certified dermatologist at the Laser & Skin Surgery Center of New York.

While many aesthetic devices target skin tightening, Evolastin appears to achieve tightening and volume increase, both of which can be appreciated by comparing 3-D images taken before and after a single treatment, she says.

“The benefits of bipolar RF energy in facial skin rejuvenation are largely known, but until now, the deeper effects of RF and safety of technique were limited by its mode of delivery,” Dr. Brightman says. “Introducing bipolar RF energy directly into the dermis using a microneedling device allows us to deposit the energy where it is needed most to catalyze the skin rejuvenation process.”

Successful study Recently, Dr. Brightman conducted a study using Evolastin in 10 consecutive patients with mild to moderate facial skin laxity, with each patient receiving only one treatment. Patients were followed up to nine months and changes in volume and lift were assessed using 3-D imagery.

In the self-evaluation satisfaction questionnaire completed by nine out of the 10 patients, 44.4, 22.2 and 22.2 percent of patients evaluated their outcome as “very much improved,” “much improved” and “improved,” respectively, while 11 percent of patients scored a “no change.” No patient reported “worse change” in their evaluation.

“You can only see and appreciate so much in two-dimensional images. Measuring the change achieved in the elevation of the targeted areas using three-dimensional images removes the human bias encountered when viewing two-dimensional photographs,” Dr. Brightman says.

Evolastin therapy may be ideal for patients with mild-to-moderate facial laxity and volume loss, and/or for patients who do not want to undergo or are contraindicated for facial cosmetic surgery, Dr. Brightman says.

“I have not been able to reproduce both volume and tightening improvements with any other device that I have used to date. In my opinion, having a very high level of patient satisfaction reflects the volume and tightening changes seen in the three-dimensional imagery,” Dr. Brightman says.

Disclosures: Dr. Brightman is a clinical investigator for Syneron/Candela, and that company loaned the Evolastin device to her for the clinical trial.

Go back to the Dermatology Times eNews newsletter.

http://www.modernmedicine.com/modernmedicine/Cosmetic+Dermatology/3-D-imaging-confirms-volumizing-effects-of-fractio/ArticleStandard/Article/detail/770087?contextCategoryId=40160

WorldCare Clinical Names Kenneth O’Brien Executive Director of Quality & Regulatory Affairs.

April 17, 2012

New research adds to the growing pile of scientific strategies aimed at revealing beta-amyloid (protein) plaques, the brain-clogging fragments that have been associated with Alzheimer’s disease.

In a study funded by Bayer Healthcare Berlin, researchers report that they were able to use a drug and PET scans to successfully detect plaques in the brains of patients whose Alzheimer’s was confirmed after death.

More than 200 patients near death — including some with apparent Alzheimer’s disease — underwent the PET scans. They received doses of the drug florbetaben, which was used as a “tracer” to allow the PET scans to detect the plaques.

Thirty-one patients died and had autopsies to confirm that they had Alzheimer’s disease. The researchers determined that one way of interpreting the PET scan results correctly pinpointed Alzheimer’s disease 100 percent of the time and correctly ruled it out 92 percent of the time.

“These results confirm that florbetaben is able to detect beta-amyloid plaques in the brain during life with great accuracy and is a suitable biomarker,” study author Dr. Marwan Sabbagh, director of Banner Sun Health Research Institute in Sun City, Ariz., said in an American Academy of Neurology news release.

“This is an easy, noninvasive way to assist an Alzheimer’s diagnosis at an early stage. Also exciting is the possibility of using florbetaben as a tool in future therapeutic clinical research studies where therapy goals focus on reducing levels of beta-amyloid in the brain,” Sabbagh added.

Dr. William Jagust, a professor of neuroscience at the University of California, Berkeley’s Helen Wills Neuroscience Institute, said several companies are developing ways to detect beta-amyloid plaques. “It’s a very important development in our field,” he said. “The big practical question is how much is this going to cost — it may cost $2,000 or more to get a scan — and whether it is worth it considering what we can do for such patients.”

There’s no cure for Alzheimer’s and no way to reverse it, although drugs are available to treat symptoms. Still, Jagust said, detecting beta-amyloids may be helpful as a way to determine whether experimental drugs actually work.

The study is slated for presentation at the American Academy of Neurology’s annual meeting, which starts April 21 in New Orleans.

The data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

For more about Alzheimer’s disease, try the U.S. National Library of Medicine.

Copyright © 2012 HealthDay. All rights reserved.

http://health.usnews.com/health-news/news/articles/2012/04/17/new-method-to-reveal-alzheimers-marker-shows-promise

Boston, Mass., April 17, 2012 — WorldCare Clinical, LLC (WCC), a leading imaging CRO focused on maximizing the precision and accuracy of independent assessments in clinical trials, today announced that Kenneth O’Brien has joined the organization as executive director of quality and regulatory affairs. In his role, O’Brien will be responsible for all quality assurance and regulatory affairs operations, including ensuring regulatory compliance and computer system validation processes.

“Ken brings a wealth of regulatory, pharmaceutical and quality systems experience, and we’re pleased to welcome him aboard,” said Richard Walovitch, PhD, president of WorldCare Clinical, LLC. “His extensive knowledge in planning and implementing complex business and quality systems will be invaluable, particularly as it relates to broadening our expertise in maximizing the precision and accuracy of independent assessments in clinical trials.”

Prior to joining WCC, O’Brien was responsible for quality system implementation and regulatory compliance for PAREXEL International, Perceptive Informatics, Phase Forward, and Domain Pharma. In the last 15 years, he has implemented quality systems and provided regulatory support for multiple technologies, including imaging, IVRS/IWRS, EDC, clinical trial management systems, clinical data management systems, safety reporting systems, and web portal systems. O’Brien is a retired United States Marine Corps Reserve, Gunnery Sergeant.  He served as an aviation communications and navigation technician for the Marine Corps’ Huey helicopter during his time in the Marines.

For more information on WCC’s regulatory services, visit http://www.wcclinical.com/our-expertise/#page-Regulatory-Expertise.

About WorldCare Clinical

WorldCare Clinical (WCC) is a leading imaging CRO that employs imaging expertise, innovative technology and operational excellence to maximize the precision and accuracy of a blinded independent central review of clinical trial data. Originally founded in 1992 by the Massachusetts General Hospital (MGH) Department of Radiology, WCC has evolved as an independent company while maintaining a strategic relationship with MGH.  With a 20-year focus on imaging trials and their specific requirements, WCC provides sponsors with extensive medical, operational, and image management expertise in support of even the most complex study designs. For more information, visit www.wcclinical.com.

For more information, contact:

Bree Bolognese

SVM Public Relations

(760) 754-7025

bree.bolognese@svmpr.com

April 9, 2012

By J.K. Wall

Eli Lilly and Co. says it has won approval from the U.S. Food and Drug Administration for a new imaging agent that could help physicians better diagnose Alzheimer’s disease and other forms of dementia.

The agent, called Amyvid, is not expected to produce high-dollar sales for Lilly, but it could help to identify patients with Alzheimer’s—and those without it—earlier than other methods, perhaps improving treatment and focusing research efforts.

Indianapolis-based Lilly is currently studying an experimental treatment for Alzheimer’s disease, solanezumab, which if successful, could become a multibillion-per-year blockbuster and reverse Lilly’s recent struggles with expiring patents on its older blockbuster products. No treatment exists that slows or reverses the progression of Alzheimer’s disease, which currently afflicts about 30 million people worldwide and is expected to afflict three times that number by 2050.

However, even Lilly officials say the chance of the solanezumab’s success is low. That’s because scientists do not completely understand what causes Alzheimer’s disease. So efforts by Lilly and other major pharmaceutical companies to develop treatments is based so far on unproven theories.

Lilly’s scientists have followed the theory that Alzheimer’s is caused by the buildup of the protein beta-amyloid in a patient’s brain, which eventually forms sticky plaques that impede brain function. Solanezumab binds to amyloid in an effort to remove it from the brain via the bloodstream. And the imaging agent Amyvid binds to amyloid plaques, making them detectable using a PET scan.

Previously, the presence of amyloid plaques could only be confirmed by an autopsy, after a patient’s death. And sometimes the diagnosis of Alzheimer’s was proved wrong.

“It’s estimated that one in five patients clinically diagnosed with probable Alzheimer’s Disease during life do not end up having Alzheimer’s Disease pathology upon autopsy,” said Dr. Daniel Skovronsky, CEO of Avid Radiopharmaceuticals Inc., the company that developed Amyvid, and which Lilly acquired in 2010 for $300 million. “The approval of Amyvid offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients.”

Amyvid will become available in limited supplies in June. The FDA approval comes more than a year after the agency was first scheduled to make a decision on the drug.

http://www.ibj.com/lilly-wins-fda-approval-for-alzheimer-s-imaging-agent/PARAMS/article/33717

April 9, 2012

By J.K. Wall

Eli Lilly and Co.’s newest drug is a boon for Alzheimer’s research but is likely to bring the Indianapolis drugmaker less than $100 million in annual sales—at least initially, according to one of the few analysts to make a forecast.

Lilly won approval Friday from the U.S. Food and Drug Administration for Amyvid, a new imaging agent that could help physicians better diagnose Alzheimer’s disease and other forms of dementia. Amyvid binds to amyloid plaques, which are a telltale sign of Alzheimer’s disease, making them detectable using a PET scan.

Amyvid will sell at a wholesale price of $1,600 per dose, with distributors likely discounting slightly from that price. The cost of the PET scan is on top of that.

Right now, the federal agency that runs the Medicare and Medicaid programs does not reimburse for imaging agents and scans, and neither do many private health insurance plans. That will limit Lilly’s revenue initially, ISI Group analyst Mark Schoenebaum said in a weekend note to investors.

Even if health insurance start paying, there are only about 450,000 Americans diagnosed with Alzheimer’s each year. So Amyvid could at best produce total U.S. sales of $700 million.

Schoenebaum predicted that Lilly might only generate about $200 million in annual U.S. sales, because the training programs doctors must take to be able to read the Amyvid PET scans are cumbersome, in his view, which will limit the number of doctors that use the drug.

If Lilly were to win approval for Amyvid in Europe, Lilly might tack on another $300 million in annual sales, Schoenebaum predicted.

So far, most analysts who follow Lilly have yet to forecast any specific amount of sales for Amyvid. Investors shrugged at the FDA approval in Monday trading, pushing Lilly’s stock down at roughly the same rate the broader markets declined.

But where Amyvid could prove especially useful is in research for a treatment for Alzheimer’s disease. By helping doctors identify which patients have Alzheimer’s and which do not, Amyvid could help focus research efforts to the right set of patients.

Amyvid scans still will be only part of a doctor’s diagnosis, which will still rely mainly on questioning patients to assess their cognitive abilities. But the Amyvid scans can now show the presence or absence of amyloid plaque, which before could not been seen until an autopsy.

So far, no drug has been shown conclusively to slow or reverse progression of the memory-sapping disease. That’s why analysts project that the first effective treatment would be an enormous blockbuster, perhaps achieving sales of $10 billion per year.

Lilly has been trying to launch such a drug. It had one drug, called semagacestat, fail spectacularly in 2010. Another experimental drug, called solanezumab, is in a final-stage clinical trial. Other companies, such as New Jersey-based Merck & Co. Inc. and New York-based Pfizer Inc., also are trying to develop Alzheimer’s treatments.

In addition to solanezumab, Lilly has another Alzhimer’s treatment in a Phase 1 clinical trial.

http://www.ibj.com/new-lilly-drug-has-small-sales-potential/PARAMS/article/33736

Imaging in Clinical Trials – Removing Bias and Increasing Precision and Accuracy. Holiday Inn Boston at Beacon Hill, Boston. WorldCare Clinical in conjunction with the Massachusetts General Hospital (MGH) Department of Radiology. http://www.wcclinical.com/the-knowledge-center/in-the-news/wcc-conference/

In response to FDA guidance and growing requests from other regulatory agencies that place new emphasis on assessing and minimizing cardiovascular risk, WorldCare Clinical has added a service offering that supports expert readers in a timely and transparent manner to complete cardiovascular endpoint committee reviews quickly and cost-effectively.

March 2012

Radiology faculty are leading an investigation to improve imaging options available to patients who have undergone Selective Internal Radiation Therapy (SIRT), the latest treatment option available at the University of Tennessee Medical Center for those with inoperable hepatic tumors. SIRT is a non-surgical therapy that uses microscopic radioactive spheres, called SIR-Spheres®, to deliver radiation directly to the site of the liver tumor.

The procedure involves injecting billions of microscopic acrylic spheres (microspheres) containing the radioactive isotope Yttrium-90 into the liver tumor through the right or left hepatic artery. The microspheres lodge in the area of the tumor, where the radiation kills and slows the growth of the cancer cells. To optimize this treatment, the location of the microspheres is commonly imaged using a nuclear medicine SPECT scan.  However, for technical reasons, SPECT is only capable of providing crude images of the Yttrium-90 isotope.

At the UT Graduate School of Medicine, Anastasia Balius, MD, Assistant Professor of Interventional Radiology, is leading a clinical trial with J. Mark McKinney, MD, Chair of Radiology, and Alexander Pasciak, PhD, Assistant Professor and Medical Physicist, to determine if PET/CT technology, considered the cutting-edge in oncology for its sensitivity to cancer, can be used to improve SIRT treatment by providing imaging which is superior to the traditional SPECT scan. Dr. Balius said, “Patients that come to the University of Tennessee Medical Center for SIRT have the opportunity to participate in exciting new PET/CT research that has the potential to improve SIR-Spheres® delivery and follow-up. We are one of a select few facilities in the nation participating in this type of investigation for advanced liver cancer.”

At the forefront of PET/CT imaging equipment is the Siemens Biograph mCT PET/CT scanner, which the research team utilizes for this clinical trial. It is through an ongoing collaborative research relationship with Siemens, a global leader in medical imaging, that this technology is available at the UT Graduate School of Medicine.

While treatment with SIR-Spheres® is generally not regarded as a cure to liver cancer, it has been shown to shrink liver cancer more than chemotherapy alone.

“SIR-Spheres delivers more radiation targeted directly to tumors and spares more healthy tissue than would be possible using conventional external radiation,” said Dr. J. Mark McKinney, Radiology Chair and Interventional Radiologist at the University of Tennessee Medical Center. “This new capability allows us to treat tumors in the liver regardless of the size or location with a precise, yet high dose of radiation. The treatment has been shown to shrink liver tumors and improve the quality of patients’ lives.”

The University of Tennessee Medical Center is the only site in East Tennessee offering SIR-Spheres® for the treatment of liver cancer. SIR-Spheres® is one of many options among a full array of treatments made available for patients with primary/metastatic liver disease. In addition to SIRT, other procedures to treat liver cancer include: surgery, radiofrequency ablative therapy, chemoembolization and stereotactic radiation therapy.

http://gsm.utmck.edu/newsletter/0312/radiology.cfm