Advertising Index March 2008 In The Pipeline he experimental treatment for metastic melanoma elesclomol has been Advertiser. Page Tgranted orphan drug status by the FDA, GlaxoSmithKline and Synta Pharmaceuticals announced. Elesclomol is a novel, injectable, drug candi- Abbott Laboratories. 2-5 date that kills cancer cells by elevating oxidative stress levels beyond a breaking point, triggering programmed cell death, the companies explain. www.abbott.com In a phase 2b clinical trial, 81 patients were randomly assigned in a 2:1 (847) 937-6100 ratio to receive elesclomol in combination with paclitaxel versus paclitaxel alone. Treatment was once per week for three weeks, followed by one week with no treatment. Patient population included only Stage IV patients with Allergan . 13 one or no prior chemotherapies and no brain metastases. The primary end- www.allergan.com/site/skin point was progression-free survival (PFS), defined as the time from patient (714) 246-4500 randomization until the earliest sign of disease progression or death. Results indicated that the addition of elesclomol doubled median PFS, from 1.8 to 3.7 months, and more than doubled the percentage of patients DUSA Pharmaceuticals. 48-50 free of progression at six months, from 15 percent to 35 percent. The haz- ard ratio was 0.58, indicating a 42 percent reduction in risk of disease pro- www.dusapharma.com gression for patients receiving the combination treatment versus patients (877) 533-3872 receiving control treatment. Patients randomized to receive elesclomol plus paclitaxel experienced a substantially longer median survival com- pared to patients who initially received paclitaxel alone. Galderma. 19-20 Adverse events including hypoaesthesia, neutropenia, stomatitis, www.galdermausa.com arthralgia, and fatigue occurred with higher incidence in the elesclomol (817) 961-5000 plus paclitaxel group, though incidences of adverse evens were generally comparable between the two groups. Moreover, safety data were consis- tent with pooled safety analyses from all trials in which patients received Graceway Pharmaceuticals. 9-11 elesclomol in combination with paclitaxel. The FDA's decision allows an accelerated clinical trials program for www.gracewaypharma.com elesclomol because the patient population is small and there are currently (800) 447-4537 no adequate treatments for metastatic melanoma, GSK and Synta note. I Merz . 34-35 www.merz.com (888) 637-9872 Stiefel. 54 www.stiefel.com/USA (888) 784-3338 For advertising inquiries, please contact Tom Gangemi, Publisher (610) 238-9052, ext. 11 or [email protected].