ALZHEIMER’S: STUDY LINKS DIABETES TO AD
Researchers at the Salk Institute for Biological Studies in La Jolla, California identified the probable molecular basis for the connection between diabetes and Alzheimer’s disease. Diabetic individuals have a significantly higher risk of developing Alzheimer’s disease, but the connection has been unexplained. In a study published in the current online issue of Neurobiology of Aging, the researchers report that the blood vessels in the brain of young diabetic mice are damaged by the interaction of elevated blood glucose levels characteristic of diabetes and low levels of beta amyloid, a peptide that clumps to form the senile plaques that riddle the brains of Alzheimer’s patients. Although the damage took place long before the first plaques appeared, the mice suffered from significant memory loss and an increase in inflammation in the brain. Alzheimer’s and diabetes are two diseases that are increasing at an alarming rate within the U.S. population. Alzheimer’s affects one in 10 Americans over 65 years of age and nearly 50 percent of those over 85 years old. Similarly, 7 percent of the population, or approximately 20 million Americans, have diabetes, with the vast majority of these individuals being over 60. Diabetic patients have a 30 percent to 65 percent higher risk of developing Alzheimer’s disease compared to non-diabetic individuals.

 

Stem cell researchers at the University of California, Los Angeles grew functioning cardiac cells using mouse skin cells that had been reprogrammed into cells with the same unlimited properties as embryonic stem cells. The finding is the first to show that induced pluripotent stem cells, which don’t involve the use of embryos or eggs, can be differentiated into the three types of cardiovascular cells needed to repair the heart and blood vessels. The discovery could one day lead to clinical trials of new treatments for people who suffer heart attacks, have atherosclerosis, or are in heart failure, the researchers said. The researchers were able to differentiate the induced pluripotent stem cells into several types of blood cells, which may one day aid in treating blood diseases and in bone marrow transplantation.

DIABETES: ARADIGM SAYS DATA SHOWS NO OCCURRENCE OF LUNG CANCER IN PATIENTS TREATED WITH INHALED INSULIN

Hayward, California-based Aradigm said that review of the clinical data from its inhaled insulin collaboration partner Novo Nordisk revealed no occurrence of primary lung cancer in patients inhaling insulin using the AERx insulin Diabetes Management System. The AERx system uses an aqueous formulation of insulin delivered by a handheld electronic inhaler. Review of the clinical trial data showed no cases of primary lung cancer either in the 2,307 patients treated with the AERx system or in the 1,218 patients treated with comparator treatments. Additionally, there were no treatment-related changes seen in the lungs of rats following a six-month exposure period or in monkeys exposed for a nine-month period. Aradigm said it believes that the market for inhaled treatments of chronic respiratory diseases is estimated at approximately $20 billion and growing at over 10 percent a year. Novo Nordisk previously announced the termination of its late-stage clinical trials for fast-acting inhaled insulin delivered via AERx system. Novo Nordisk stated they were not terminating the trials because of any safety concerns. The latest by Novo Nordisk was in response to an announcement made by Pfizer on April 24 that it has updated the product labeling for its inhaled insulin product Exubera to include a warning about lung cancer cases observed in patients who received Exubera in its clinical program.

 

HIV: RESEARCHERS SYNTHESIZE COMPOUND TO FLUSH VIRUS OUT OF HIDING
Though antiretroviral “cocktails” can target an active HIV infection, they cannot get at the virus when it retreats inside the host’s T cells, where it may lie dormant for decades, waiting for an opportunity to burst forth in a fresh round of infection. Researchers at Stanford University said they have found a way to synthesize agents that can be tailored to flush HIV out into the open where the immune system and antiretroviral therapies can destroy it. In a paper in the journal Science, the researchers said they have developed a way to synthesize prostratin and DPP, two compounds that occur naturally in plants, in the laboratory. Prostratin, found in the Mamala plant (Homalanthus nutans) that grows in the Samoan rainforest, has shown promise in previous studies as an activator of dormant HIV. DPP, a molecular relative of prostratin found in resin spurge (Euphorbia resinifera), which grows in arid regions, also has shown potential. Research has been hampered, though, because the compounds are difficult to obtain, particularly in the quantities needed for practical lab work on their mode of action and therapeutic potential. Synthetic prostratin and DPP, which now can be readily made in the lab, changes that equation. 

 

HEART FAILURE: STUDY IDENTIFIES FACTORS LEADING TO HOSPITAL ADMISSION
Nearly two out of three patients nationwide have one or more precipitating factors that may contribute to hospital admissions for heart failure, according to researchers at the University of California, Los Angeles. Pneumonia, irregular heart beats, and obstructed blood flow to the heart are the most frequent factors, according to the study published in the Archives of Internal Medicine. Researchers identified additional health factors present at hospital admission that contributed to the hospitalization and impacted length of hospital stay, re-hospitalization, and mortality both in the hospital and post-discharge. Heart failure affects 5 million Americans, and nearly 3.6 million hospitalizations each year are attributed to the condition, which occurs when the heart’s left ventricle can’t pump enough blood to the body’s other organs. The most frequent factors contributing to hospital admission included pneumonia or respiratory ailments (15.3 percent), obstructed blood flow to the heart (14.7 percent), irregular heart beat (13.5 percent), and uncontrolled hypertension (10.7 percent). Other factors included not adhering to a special diet (5.2 percent), not taking medications (8.9 percent), and worsening kidney function (6.8 percent).

 

ANTICOAGULATION: NUVELO SAYS IT HAS PROOF-OF-CONCEPT FOR THROMBIN-INHIBITOR
San Carlos, California-based Nuvelo said it achieved positive results from the early-stage clinical proof-of-concept trial of thrombin-inhibitor known as NU172, a possible alternative to Heparin. The company said NU172 achieved rapid onset and offset of anticoagulation after a single dose with a favorable safety profile. The company is pursuing NU172's potential to address the need for rapid onset and offset of anticoagulation in medical procedures such as coronary artery bypass graft surgery and percutaneous coronary intervention. Heparin, which must be paired with its antidote protamine for reversal, is the current standard of care for anticoagulation in coronary artery bypass graft procedures and more than 1.2 million percutaneous coronary interventions surgeries.

 

PROSTATE CANCER: COUGAR BIOTECHNOLOGY BEGINS ENROLLING PATIENTS IN LATE-STAGE TRIAL
Los Angeles-based Cougar Biotechnology said it has started enrolling patients in its late-stage clinical trial of its lead drug candidate CB7630. CB7630 is an orally administered inhibitor of the steroidal enzyme that is involved in testosterone production. The trial is randomized, double-blind, placebo-controlled and will test CB7630 plus prednisone in patients with metastatic castration-resistant prostate cancer who have failed docetaxel-based chemotherapy. Patients are allowed to have received up to two prior chemotherapy regimens before entering the trial. The trial will enroll approximately 1,160 patients who will be randomized to receive CB7630 plus prednisone or placebo plus prednisone. The trial will be conducted at approximately 150 sites in North America, Europe, and Australia. The primary endpoint of the trial will be survival.

EYE ALLERGIES: ISTA PHARMACEUTICALS REPORTS POSITIVE LATE-STAGE CLINICAL RESULTS TO SUPPORT FILING WITH FDA
Irvine, California-based ISTA Pharmaceuticals announced positive results from the preliminary analysis of its second and final late-stage clinical study of its eye allergy drug Bepreve. The U.S. multi-center study evaluated the onset and duration of effect of two Bepreve concentrations in 130 patients with a history of eye allergies. Both concentrations demonstrated highly statistically significant reducing itching of the eye. In addition, both concentrations produced highly statistically significant effects on the rapidity of response and in the secondary endpoints measuring additional signs and symptoms of ocular allergy, as well as improvement in total nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve. ISTA expects to file a new drug application with the U.S. Food and Drug Administration during the second half of 2008.

 

TOXICS: COMMON WEEDKILLER FOUND TO ALTER HORMONAL SIGNALING IN HUMAN CELLS
A common weedkiller in the United States, already suspected of causing sexual abnormalities in frogs and fish, has now been found to alter hormonal signaling in human cells, according scientists from the University of California San Francisco. The herbicide known as atrazine is the second most widely used weedkiller in the U.S. It is applied to corn and sorghum fields throughout the Midwest, and also spread on suburban lawns and gardens. Atrazine was banned in Europe after studies linked the chemical to endocrine disruptions in fish and amphibians. The study, published in the journal PLoS ONE, is the first to identify its full effect on human cells. In studies with human placental cells in culture, the UCSF scientists found that atrazine increased the activity of a gene associated with abnormal human birth weight when over-expressed in the placenta. Atrazine also targeted a second gene that has been found to be amplified in the uterus of women with unexplained infertility.