The Medical Expert Report

Researchers from the John Theurer Cancer Center at Hackensack University Medical Center played an important role in a study that led to the Food & Drug Administration's (FDA) recent fast tracking of ipilimumab, a promising treatment for metastatic melanoma. The FDA based its decision largely on the results of a pivotal study published in the New England Journal of Medicine on August 19, 2010 the same day the agency accepted Bristol-Myers Squibb's application for the drug's approval and granted the application priority review status...

Tengion, Inc., a leader in regenerative medicine, announced it has added The Johns Hopkins Hospital in Baltimore, Maryland as a second clinical trial site for its Phase I clinical trial of the Company's lead product candidate, the Tengion Neo-Urinary Conduit™, in bladder cancer patients requiring bladder removal. "The addition of Johns Hopkins as the second clinical trial site is expected to expand enrollment efforts already underway at the University of Chicago site by expanding the pool of potential patients considered for entry in the trial," said Steven Nichtberger, M.D...

ReVision Optics (RVO), a leading company in the research, development and manufacture of implantable medical devices designed to assist patients that need reading glasses, announced that it has completed enrollment and initial follow up in Phase I of its US clinical trial and has filed for expansion. The clinical trial is for the study of the PresbyLens, recently renamed Vue+, for the improvement of near vision in patients with presbyopia, the age-related loss of near vision. The Vue+ study will evaluate 400 presbyopic subjects for three years. The investigators for Phase I included Dr...

ImmunoCellular Therapeutics (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, announced long-term data from a Phase I clinical trial of ICT-107, the Company's lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The data show six out of 16 (37.6%) patients who received ICT-107 were disease-free after more than two years, with three of these patients (18.8%) remaining disease-free for more than three years...

One third of the world's population is infected with Mycobacterium tuberculosis (MTB), which leads to tuberculosis (TB), a leading cause of death world-wide. A new discovery, led by a team of researchers from Case Western Reserve University School of Medicine, offers hope for new approaches to the prevention and treatment of TB. The team's discovery of a novel mechanism that may contribute to immune recognition of MTB is published in the September issue of Nature Structural and Molecular Biology...

The Virginia Commonwealth University Medical Center is the lead institution in a national clinical trial of technology that will allow artificial heart patients to recuperate, rehabilitate and wait in the comfort of their own homes until a donor heart becomes available for transplant. The VCU Pauley Heart Center is one of up to 30 centers that will investigate a portable, mechanical driver that can power patients' artificial hearts and enable them to recover outside the hospital environment, including at home and at step-down facilities...

Neurons are cells in the brain and body that communicate with one another by electrical and chemical signals -- like messages traveling along phone lines -- but scientists have observed that these cells purposefully hold back their full potential. Now, for the first time, scientists from Weill Cornell Medical College may be able to explain this behavior, but more importantly, how to boost a neuron's signaling...

Mayo Clinic unveiled a newly expanded, state-of-the-art neurophysiology laboratory on its Florida campus to provide additional services and care for more patients, many of whom are referred by community physicians for specialized diagnostic testing. The new facility includes an increased number of exam rooms and enhanced equipment for electromyography (EMG) and electroencephalography (EEG) testing, and unique autonomic testing. "The new lab will increase our efficiency and excellence in performing and interpreting different types of neurophysiologic tests," says Devon Rubin, M.D...

Experts at The University of Texas MD Anderson Cancer Center advise men to keep a record of their prostate specific antigen (PSA) test results to help determine if they are at increased risk for prostate cancer. "Recent reports have debated the usefulness of the PSA test, but men should not write off this exam," says John W. Davis, M.D., assistant professor in MD Anderson's Department of Urology. "It's still an effective way to track trends in your prostate over time," he says...

Admissions for substance abuse treatment among those aged 50 and older have more than doubled, and their sociodemographic characteristics have significantly changed, between 1992 and 2008, according to a study by the Substance Abuse and Mental Health Services Administration (SAMHSA). The findings indicate that sociodemographic factors such as unemployment, lack of income and homelessness all increased among this treatment group during this period...

Early signs of Alzheimer's disease can be difficult to distinguish from the normal aging process in any older adult. For adults with Down syndrome, who are particularly vulnerable to Alzheimer's disease, it is even more so. Because effective intervention needs to begin as early in the disease process as possible, prior to the onset of the irreversible impacts on the brain that are characteristic of this devastating disease, early diagnosis is of critical importance...

Commenting on today's ministerial announcement on the National Programme for IT in the NHS in England, Dr Chaand Nagpaul of the BMA's GPs committee, said: "Giving NHS organisations more choice of IT systems makes sense, but we also need to be aware of the problems that could arise from a more localised approach. "The provision and experience of IT for clinicians on the ground is likely to vary according to the level of support and resources available locally. It is important that successful national IT initiatives are not lost, and that innovation is not stifled...

Santarus, Inc. (NASDAQ: SNTS), S2 Therapeutics, Inc. and VeroScience LLC today announced that they have entered into a distribution and license agreement granting Santarus exclusive rights to manufacture and commercialize CYCLOSET® (bromocriptine mesylate) tablets in the U.S. CYCLOSET is a prescription drug approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus both as mono-therapy and in combination with other oral antidiabetic agents...

ALLPRO Imaging, a leader in digital imaging systems, introduces the ScanX Quantum, the most compact and versatile system for community health centers interested in upgrading to digital. It is the only system capable of body images up to 14" wide by any practical length and dental images in sizes 0-4. Made in the U.S.A., the ScanX Quantum is compact and lightweight (only 43 lbs.) and can be wall-mounted to save space. The system can be used for all human dental and medical radiography applications...

Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject. Emergent's fully human monoclonal antibody product candidate is being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease. The Phase I clinical trial, involving 50 healthy volunteers, is a randomized, double-blind, placebo-controlled, dose escalation study designed to evaluate the safety and pharmacokinetics of the monoclonal antibody candidate...

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, which currently cares for over 49,000 AIDS patients in Uganda through its Uganda CARES network of eleven treatment clinics throughout the country, lauded the United States government for increasing its funding commitment in Uganda for the President's Emergency Plan for AIDS Relief (PEPFAR), the United States' respected global AIDS program...

Nearly one-third of Americans have experienced a Hospital Acquired Infection (HAI) or have a friend or relative who contracted one, according to a new survey from Xenex Healthcare. HAIs (such as C. diff, MRSA, staph infections and pneumonia) are the fourth leading cause of death in the U.S., according to the Centers for Disease Control and Prevention, and while hospitals have stepped up efforts to prevent these deadly infections, more needs to be done. Evidence continues to mount that hospital cleanliness plays a role in the spread of HAIs...

New facilities opening tomorrow will help scientists in York develop drugs and vaccines to combat chronic diseases that devastate the lives of millions of people across the world. The new £5m home for the Centre for Immunology and Infection (CII) will help researchers to make an important contribution to international efforts to better understand some of the world's most important chronic diseases, and develop strategies for prevention and cure. In developed countries, lives are severely debilitated by Crohn's Disease, diabetes and HIV/AIDS...

Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) announced the initiation of an international 700-patient, phase 3 trial of oral methylnaltrexone in patients with chronic, non-cancer pain who are experiencing constipation as a result of their opioid-pain management regimens. The goal of the study is to evaluate the safety and efficacy of oral methylnaltrexone to treat opioid-induced constipation (OIC) in this patient setting. "An oral formulation of methylnaltrexone, if successfully tested and approved, would be an important addition to the RELISTOR® franchise," said Paul J. Maddon, M.D...

More than 7,000 psychiatrists, neurologists, psychologists and neuroscience researchers from all over the world met at the 23rd Congress of the European College of Neuropsychopharmacology (ECNP) from 28 August to 1 September 2010 in Amsterdam. The ECNP Congress is the largest scientific meeting on mental health in Europe, and this year included 46 sessions presented by more than 150 distinguished speakers from 20 countries...