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New Treatment Approach Gives Patients With Incurable Lung Cancer More Time Without Disease Progression Compared To Placebo
Results from a Phase III study presented at the American Society for Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida today show that patients with advanced non-small cell lung cancer (NSCLC) who received erlotinib (Tarceva®) as first-line maintenance treatment benefited from a significant (29%) improvement in the time they lived without the disease advancing, compared with those who received placebo1. Patients in the global multicentre SATURN trial, which included patients from the UK, received maintenance treatment with erlotinib if their cancer had not progressed on initial chemotherapy. The data showed a significant improvement in the length of time patients lived without their disease getting worse, and without the need for further chemotherapy. 1 The improvement was seen in both of the main types of NSCLC (squamous cell as well as non-squamous cell) and these results form the basis of a submission for regulatory approval of erlotinib to be used in the first-line maintenance setting. 1 Erlotinib is not currently licensed for first line maintenance treatment in NSCLC lung cancer in the UK.
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G8 Summit Begins Wednesday; WFP Calls For 'Twin-Track' Approach To Food Security
The G8 summit is scheduled to open Wednesday in L"Aquila, Italy. The World Food Program (WFP) on Tuesday issued a statement praising the G8 leaders" focus on food security and calling for support of its efforts to combat hunger among the world"s poorest people, Xinhua reports. In the statement, WFP Executive Director Josette Sheeran recommended leaders take a "twin-track" approach to food security, which includes supporting long-term agricultural production along with immediate hunger assistance.
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NeurogesX Announces New PDUFA Date For Qutenza(TM) New Drug Application
NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date from August 16, 2009 to November 16, 2009 to review the new drug application (NDA) for Qutenza(TM) to manage pain associated with postherpetic neuralgia (PHN).
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Multiple Sclerosis Patients Benefit From Diabetes Drug

A drug currently FDA-approved for use in diabetes shows some protective effects in the brains of patients with relapsing remitting multiple sclerosis, researchers at the University of Illinois at Chicago College of Medicine report in a study currently available online in the Journal of Neuroimmunology. In a small, double-blinded clinical trial, patients with relapsing remitting multiple sclerosis were assigned to take pioglitazone (a drug commercially known as Actos used to treat type-2 diabetes) or a placebo. Patients continued their normal course of therapy during the trial. Standard neurological tests were done initially, as were MRI scans to provide baseline values for lesions typically seen in MS patients. The patients were evaluated every two months, and blood samples were taken. Repeat MRI scans were done after five months and again after one year. Patients taking pioglitazone showed significantly less loss of gray matter over the course of the one-year trial than patients taking placebo. Of the 21 patients who finished the study, patients taking pioglitazone had no adverse reactions and, further, found taking pioglitazone, which is administered in an oral tablet, easy. "This is very encouraging," said Douglas Feinstein, research professor of anesthesiology at UIC. "Gray matter in the brain is the part that is rich in neurons. These preliminary results suggest that the drug has important effects on neuronal survival." Feinstein"s lab has been interested in the class of drugs called thiazolidinediones, or TZDs. Several TZDs have been approved for use in the treatment of type-2 diabetes because of the drugs" effect on the body"s response to insulin. The researchers focused on pioglitazone because of its known anti-inflammatory effects, Feinstein said. They used primary cultures of brain cells to show that pioglitazone reduced the production of toxic chemicals called cytokines and reactive oxygen species. These molecules are believed to be important in the development of symptoms in MS. Feinstein"s lab proceeded to test pioglitazone in an animal model of MS. They and others showed that pioglitazone and other TZDs "can significantly reduce the clinical signs in mice with an MS-type disease," said Feinstein. "More importantly, when mice who are already ill are treated with pioglitazone, the clinical signs of the disease go away," he said. "We were able to induce almost complete remissions in a number of mice." "We are now working to determine the mechanisms to explain the protective effect on neurons that we see in our studies," said Feinstein. "We hope to expand into a larger trial to confirm these preliminary results." Claudia C. Kaiser, who was a post-doctoral student at UIC, is first author on the paper. Other authors are Dinesh Shukla and Demetrios Shias of UIC; Glen Stebbins, Dusan Stefoski and George Katsamakis of Rush University Medical Center; and Douglas Jeffrey of Wake Forest University School of Medicine. Takeda Pharmaceuticals funded the study and provided the drug but had no other involvement in the study. Jeanne Galatzer-Levy University of Illinois at Chicago


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