Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma Abraxis BioScience.

The principal efficacy endpoint is usually progression-free survival and the primary secondary endpoint is general survival . Other secondary endpoints include safety and tolerability of the regimens, nab-paclitaxel pharmacokinetic parameters, effects of therapy on and the relationship of response to the levels of SPARC and gene methylation, other and mutational biomarkers, response rate, steady disease rate at greater than or equal to 16 duration and weeks of response. Dosage reductions of nab-paclitaxel to 120 and 90 mg/m2 and of dacarbazine to 800 and 600 mg/m2 and the usage of filgrastim for neutropenic fever are allowed. Efficacy is assessed by CT scans eight weeks in both hands every. The study accrual goal is 514 patients, randomized to 257 patients per treatment arm. A total of 104 multinational sites are anticipated.Jacobs, M.D., John S. Bradley, M.D., Joan L. Robinson, M.D., Tag Shelton, M.D., Penelope H. Dennehy, M.D., Charles Leach, M.D., Mobeen Rathore, M.D., Nazha Abughali, M.D., Peter Wright, M.D., Lisa M. Frenkel, M.D., Rebecca C. Brady, M.D., Russell Van Dyke, M.D., Leonard B. Weiner, M.D., Judith Guzman-Cottrill, D.O., Carol A. McCarthy, M.D., Griffin Jill, R.N., Penelope Jester, R.N., M.P.H., Misty Parker, M.D., Fred D. Lakeman, Ph.D., Huichien Kuo, M.S., Choo Hyung Lee, M.S., and Gretchen A. Cloud, M.S. For the National Institute of Allergy and Infectious Illnesses Collaborative Antiviral Study Group: Oral Acyclovir Suppression and Neurodevelopment after Neonatal Herpes The outcomes of neonatal herpes virus disease are dependent on the extent of the disease.1 Approximately 30 percent of infants with disseminated disease die, but only 20 percent of survivors possess neurologic sequelae.2 In contrast, only 6 percent of infants with central nervous system disease die, but approximately 70 percent have long term neurologic impairment.2 Skin, eye, and mouth area disease is not connected with death, and neurologic impairment is rare with this manifestation of neonatal herpes.3 HSV establishes in sensory ganglia latency, with periodic reactivation and recurrence of localized disease.4,5 Whether the virus subclinically reactivates in the mind after neonatal HSV disease is not known.