Cornerstone moves drug testing site for investigational cancer treatment
CRANBURY, N.J. Early- and mid-stage clinical trials of an investigational drug for treating cancer have a new testing site, the drug’s developer said Monday.
Privately owned drug maker Cornerstone Pharmaceuticals announced that the phase 1 and phase 2 trials of the drug CPI-613 would include a site owned by Pivotal Research Centers in Peoria, Ariz. CPI-613 is part of a new drug class developed using Cornerstone’s Altered Energy Metabolism Directed technology platform designed to target metabolic changes that may be common to many cancer types. The Food and Drug Administration has given the drug orphan drug status for pancreatic cancer.
“This is a very significant development for our company as we expand the clinical trials of CPI-613 and continue to partner with institutions that share our vision of helping people to better manage their affliction,” Cornerstone CEO Robert Shorr said.
Artificial pancreas may benefit young Type 1 diabetes patients
LONDON Sleeping overnight with an artificial pancreas system benefits children and teenagers with Type 1 diabetes, according to a study published in the Feb. 5 issue of The Lancet.
The study, funded by the Juvenile Diabetes Research Foundation and conducted by researchers at the University of Cambridge in England, had participants aged 5 to 18 spend the night in a hospital using a combination of commercially available blood glucose sensors and insulin pumps controlled by a computer program that determined insulin dosage based on blood glucose levels.
The study found that the patients had targeted blood glucose levels for twice as long when they used the artificial pancreas system than when they used conventional therapy.
“These studies show that automated systems not only can help people manage diabetes by maintaining good control, they will also improve quality of life for the people with Type 1 diabetes and their families by lowering the risk of hypoglycemia,” University of Cambridge Institute of Metabolic Science researcher and lead study author Roman Hovorka said. “These results suggest that closed-loop devices may be able to significantly lower the patient’s risk of developing complications later in life by reducing or even overcoming the burden of hypoglycemia.”
FDA issues warning over safety of Tysabri use
ROCKVILLE, Md. Patients using a drug for treating multiple sclerosis may be at increased risk of developing a deadly brain infection, the Food and Drug Administration said Friday in a warning to healthcare professionals and patients.
The FDA said that 31 patients using the drug Tysabri (natalizumab), marketed by Elan Corp. and Biogen Idec, had developed progressive multifocal leukoencephalopathy, or PML, as of Jan. 21. The drug’s safety labeling has been updated to reflect the risk. Still, the agency said the benefits of the drug outweigh the potential risks.
PML is caused by the JC virus, a virus that occurs naturally in most adults but is kept in check by the body’s immune system. When the immune system becomes compromised due to diseases such as AIDS or the use of immune-suppressing drugs, the risk that the virus will multiply and cause irreversible and fatal damage to the brain increases.