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Clinical trial for Merck KGaA’s cancer vaccine continues

BY Alaric DeArment

DARMSTADT, Germany A division of German drug maker Merck KGaA has resumed its clinical trial of a vaccine for lung cancer, Merck KGaA said Thursday.

Merck Serono and U.S. affiliate EMD Serono, which operates under that name in the United States to avoid confusion with U.S.-based Merck, said they soon would start enrolling and treating patients with non-small cell lung cancer in the phase 3 “START” and “INSPIRE” studies of Stimuvax (BLP25 liposome vaccine), following approval by regulators. The Food and Drug Administration had placed a hold on the trial following reports of encephalitis in a patient during a phase 2 trial program, leading Merck Serono to suspend the trial worldwide. The hold remains in effect in a study of the vaccine in patients with advanced breast cancer.

“Merck Serono remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients,” Merck Serono EVP oncology Wolfgang Wein said. “We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients.”

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‘Battle of the bulge’ solved with Perfect Fit Button

BY Allison Cerra

FAIRFIELD, N.J. Need a quick fix for pants that just don’t fit right? Look no further than the Perfect Fit Button, an innovative new product that helps prolong the comfortable fit of pants, jeans or skirts by creating an easy way to adjust the waistband.

Made by TeleBrands, the company behind such products as storage solution Shoes Under and PedEgg, the Perfect Fit Button is the newest way to get pants and skirts to fit without having to spend extra money. It retails for $9.99 for a set of eight.

Visit PerfectFitButton.com for more information.

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Patient enrollment complete for lung cancer treatment trial

BY Alaric DeArment

SOUTH SAN FRANCISCO, Calif. Drug maker OXiGENE has finished enrolling patients for a mid-stage clinical trial of a lung cancer treatment, the company said Wednesday.

OXiGENE announced that it had enrolled 60 patients in “FALCON,” a phase 2 trial of the drug Zybrestat, a treatment for non-small cell lung cancer. The trial comprises two arms, a study arm with patients taking Zybrestat with Genentech’s Avastin (bevacizumab) and chemotherapy, and a control arm with patients taking Avastin and chemotherapy alone. OXiGENE said some preliminary results from the trial presented at the recent meeting of the American Society of Clinical Oncology have indicated that the drug is safe and effective.

“We look forward to presenting a more complete analysis of the FALCON trial later in 2010 at a scientific meeting,” OXiGENE CEO Peter Langecker said. “If the encouraging positive trends in terms of progression-free survival and overall survival that we presented at ASCO are maintained, they will underscore Zybrestat’s utility in non-small cell lung cancer and potentially pave the way toward embarking upon a registration pathway.”

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