Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

HGS/GSK On Track To Initiate Lymphostat-B Phase III Study In 2006

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Human Genome Sciences and its development partner GlaxoSmithKline are on track to initiate a Phase III study of LymphoStat-B for the treatment of systemic lupus erythematosus in 2006, HGS said.

You may also be interested in...



HGS LymphoStat-B to begin Phase III in Q4

Human Genome Sciences will begin a Phase III trial of LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus in the fourth quarter of 2006, the company announces Aug. 9. HGS expects a $24 mil. milestone payment from development partner GlaxoSmithKline in the third quarter. HGS collaborated with GSK to design the Phase III study, which has an endpoint that combines response rate and elements of the SELENA SLEDAI and BILAG disease activity indices, as well as the Physician's Global Assessment index. A Phase II study failed to show a clinical benefit at week 24, but HGS previously indicated its belief that the Phase II data are strong enough to move into Phase III studies (1Pharmaceutical Approvals Monthly July 2006, p. 16)...

HGS Refines LymphoStat-B Lupus Trial Design After Phase II Misses Endpoints

Human Genome Sciences believes it can move ahead with Phase III trials of its systemic lupus erythematosus therapy LymphoStat-B but will refine the clinical study design - including clinical endpoints - from that used in Phase II

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS003354

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel