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REGENERATIVE MEDICINE: STEM CELLS CAN IMPROVE MEMORY AFTER BRAIN INJURY
Research from the University of California at Irvine is among the first to demonstrate that neural stem cells may help to restore memory after brain damage. In the study, mice with brain injuries experienced enhanced memory—similar to the level found in healthy mice—up to three months after receiving a stem cell treatment. Scientists believe the stem cells secreted proteins called neurotrophins that protected vulnerable cells from death and rescued memory. This creates hope that a drug to boost production of these proteins could be developed to restore the ability to remember in patients with neuronal loss. The researchers, who published their study in the Journal of Neuroscience, said the work raises hopes that stem cells someday could help restore brain function in humans suffering from a wide range of diseases and injuries that impair memory formation.

 

The pharmaceutical giant Merck entered into a global license and development collaboration with Berkeley, Califronia-based Dynavax Technologies to jointly develop a hepatitis B vaccine that is currently being evaluated in a late-stage clinical trial. Under the terms of the agreement, Merck receives worldwide exclusive rights to the vaccine HEPLISAV, will fund future vaccine development, and be responsible for commercialization. Dynavax will receive an initial payment of $31.5 million, and will be eligible to receive up to $105 million in development and sales milestone payments, and double-digit tiered royalties on global sales of HEPLISAV.

 

MEDICAL DEVICES: ATHELON BEGINS CLINICAL TRIAL OF HEMOPURIFIER FOR INFECTIOUS DISEASE
San Diego-based Aethlon Medical said it has initiated clinical testing of its Aethlon Hemopurifier in human studies being conducted at the Fortis Hospital in New Delhi, India. The study will evaluate safety of the device in up to ten patients with end-stage renal disease. The Hemopurifier is a first-in-class medical device to treat infectious disease. The device removes infectious viruses and immunosuppressive proteins from circulation, thus allowing the natural immune system a greater opportunity to overcome viral infection. Commercialization of the Hemopurifier in India will be based on obtaining sufficient clinical data to drive practitioner confidence and acceptance in the marketplace. At present, government regulation in India do not address devices such as the Hemopurifier. Pending the successful completion of the study, Aethlon will focus on medical conditions of greatest concern to the people of India. Such conditions include Dengue Hemorrhagic Fever (DHF) and HIV/AIDS. In preliminary studies, the Aethlon Hemopurifier removed up to 90 percent of live dengue virus in 30 minutes.

 

Los Angeles-based Universal Detection Technology, a developer and provider of early-warning monitoring technologies to protect people from bioterrorism and radiological weapons, has signed a memorandum of understanding with EMME Consulting of Italy to test its technology at hospital and school environments for detection and decontamination of methicillin-resistant Staphylococcus aureus, or MRSA. MRSA is responsible for more than 94,000 serious infections and nearly 19,000 deaths each year. Recent reports also indicate the spread of MRSA in schools throughout the country.

 

South San Francisco-based Theravance said that GlaxoSmithKline initiated a mid-stage clinical trial of its GSK961081, a compound for the treatment of chronic obstructive pulmonary disease, or COPD. The compound, an investigational bifunctional muscarinic antagonist-beta2 agonist, was discovered by Theravance and is being developed by GSK under a strategic alliance between the two companies. The compound is a potent, long-acting, inhaled bronchodilator featuring a bifunctional mechanism of action, combining both muscarinic antagonist and beta2 agonist pharmacology in a single molecule. The goal of this program is to develop a once-a-day medicine with improved efficacy relative to existing therapies of inhaled beta2-adrenoceptor agonists and anti-muscarinic drugs used for the treatment of COPD. Currently some patients with COPD are using a combination of both an inhaled muscarinic antagonist and an inhaled beta2 agonist.

 

Irvine-based Allergan said that the U.S. Food and Drug Administration has approved COMBIGAN for the reduction of elevated intraocular pressure, or IOP, in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. COMBIGAN is a prescription eye drop that works in two ways to reduce elevated IOP and will be available to physicians in the fourth quarter of 2007. Elevated IOP is a leading risk factor for glaucoma, and the only risk factor that can currently be treated. There is no cure for glaucoma; however, lowering elevated IOP can slow the progression of the disease and help prevent further vision loss.

 

Researchers at UCLA have identified the brain circuits involved in hunger that are influenced by a hormone called leptin, suggesting possible new targets for treating obesity. In previous clinical trials, supplementation of leptin, the signaling molecule produced by fat cells, produced moderate weight loss in some obese patients, purportedly by inhibiting hunger and promoting feelings of being full. This new work was published in the Proceedings of the National Academy of Science. In order to determine the neural circuits through which leptin alters human feeding behavior, the researchers showed images of food to adults without the hormone due to a gene mutation both before and after leptin treatment, while functional MRI imaging was taking place. After leptin replacement in these individuals, feelings of hunger induced by the images and activity in certain brain regions associated with hunger—the insula, parietal, and temporal cortex—were reduced, while brain activity increased in the prefrontal cortex, an area of the brain previously associated with feeling full or satisfied.

 

LIVER CANCER: NEXAVAR BECOMES FIRST APPROVED TREATMENT MOST COMMON FORM OF THE DISEASE
Wayne, New Jersey-based Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals of Emeryville, California said that the European Commission granted marketing authorization to their drug Nexavar for the treatment of patients with hepatocellular carcinoma, the most common form of liver cancer. Nexavar, an oral anti-cancer drug, is the first approved systemic therapy for HCC and the only one shown to significantly improve overall survival in patients with the disease. Additional regulatory filings for HCC are under review in countries around the world including the United States and, most recently, Japan. Nexavar is currently approved in more than 60 countries for the treatment of patients with advanced kidney cancer. HCC is responsible for about 90 percent of the primary malignant liver tumors in adults.

 

A protein in the pancreas is giving researchers at the Stanford University School of Medicine their first chance at cracking the code that determines how diabetes develops during pregnancy, a finding that could lead to new treatments for all forms of diabetes.

The study may help explain why roughly 5 percent of women develop diabetes temporarily while pregnant, a condition called gestational diabetes. That condition is a leading cause of birth defects and can predispose the child to develop diabetes later in life. The study, published in the journal Science, reports that when the protein menin is present it blocks the growth of pancreatic cells and in that way prevents cancer. Menin was already known to have a role in preventing cancer in the pancreas and other organs. But to produce the increased levels of insulin needed during pregnancy, the pancreas accomplished the adaptive growth by producing less menin during pregnancy. The researchers also showed that a natural way of regulating the amount of menin present in the pancreas is through a hormone called prolactin, which is abundant in pregnant women. The researchers said understanding the mechanisms of regulating menin should lead to new ways of growing islets for transplantation into people with type 1 diabetes and could lead to new treatments for diabetes in pregnant women or obese adults.

RSV: TRELLIS DISCOVERS MONOCLONAL ANTIBODIES ISOLATED FROM HUMAN BLOOD CELLS
Scientists from Trellis Bioscience presented data on their discovery of monoclonal antibodies from human blood against a target protein of the respiratory syncytial virus, or RSV. The antibodies were identified and isolated directly from the antibody producing B cells of RSV-infected patients, using a proprietary process called Cellspot developed at Trellis, based in South San Francisco. These human anti-RSV antibodies are being evaluated for therapeutic utility in animal models of RSV infection. The findings were presented at the RSV 2007 Symposium held at Marco Island, Florida. RSV is a major cause of serious respiratory infections in children under age four, the elderly, and immunocompromised patients. It results in nearly 1 million hospitalizations annually. There is no specific therapy for these patients.

HEPATITIS C: DNA VACCINE DELIVERY TECHNOLOGY ADVANCE IN CLINICAL TRIAL
San Diego-based Inovio Biomedical said that its partner Tripep AB of Sweden has begun enrolling patients for its phase I/II clinical study of a novel DNA vaccine designed to treat chronically infected hepatitis C virus patients. The trial will test Tripep’s proprietary DNA vaccine, ChronVac-C, administered using Inovio’s electroporation DNA delivery technology in 12 subjects already infected with HCV. The trial is being conducted in Sweden at the Karolinska Institute. The main purpose of the study is to show that the treatment is safe, but also to test if the treatment boosts patients’ immune response to hepatitis C and its effects on virus replication. The market for therapies against hepatitis C infections is estimated at more than $2 billion and is expected to grow to more than $8 billion by 2015. DNA vaccines have the potential to bypass inherent scientific obstacles of conventional vaccines that prevent their development for cancer and chronic infectious diseases such as HIV and hepatitis C. Pre-clinical data has indicated the ability of Inovio’s technologies to effectively deliver and significantly enhance the potency of such immunotherapies without the potential safety concerns of viral delivery systems.