Clinical trial of H1N1 influenza vaccine shows good safety profile

2009 August 4
by Michael Vermillion

Sinovac announced that the clinical trial of its A/H1N1 influenza vaccine is proceeding well.

All of the volunteers received their first shot of the vaccine and, during the three day observation period, the preliminary tests indicated that the A/H1N1 influenza vaccine is safe and reliable in humans. …continue

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VivaGel Trial Achieves Primary Endpoints for Inhibiting HIV and HSV Infection

2009 August 3
by Michael Vermillion

Starpharm announced that results of a Phase II trial (NCT00740584) demonstrate that Vivagel retains antiviral activity against human immunodeficiency virus (HIV) and herpes simplex virus (HSV, the virus that causes genital herpes) following vaginal administration in women.

The study showed that cervicovaginal fluid samples (CVS) obtained immediately after vaginal administration of VivaGelĀ® provided effectively complete inhibition of HIV and HSV infection in vitro. …continue

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Dirucotide Fails to Meet Endpoints in Patients with Secondary Progressive Multiple Sclerosis

2009 July 31
by Michael Vermillion

Eli Lilly and Company and BioMS Medical Corp. announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO-01 Phase III trial (NCT00869726) in patients with secondary progressive multiple sclerosis (SPMS).

In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study. …continue

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Ofatumumab Achieves Primary Endpoint in Rheumatoid Arthritis Study

2009 July 30
by Michael Vermillion

GlaxoSmithKline and Genmab A/S announced preliminary top-line results from a Phase III study (NCT00611455) of ofatumumab administered intravenously for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate.

The study met the primary endpoint, ACR20 at 24 weeks, which indicates a 20 percent or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures. …continue

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