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Revision History For: Bios failure, 2003

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Return to Bios failure, 2003
 
Bit late, but may help to track trend.

Today, threee disapointent.

ABGX CML for GVHD:
Message 18594050

LJPC:
La Jolla Pharmaceutical Announces Results of Phase III Trial of Riquent(TM)
Tuesday February 18, 7:31 am ET

SAN DIEGO, Feb. 18 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company (Nasdaq: LJPC - News) today announced preliminary findings from a Phase III clinical trial evaluating Riquent(TM), previously known as LJP 394, for the treatment of lupus renal disease. The Company continues to analyze the results from the trial.
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The objective of the study was to determine Riquent's ability to delay the following: renal flare, treatment with HDCC (high-dose corticosteroids and/or cyclophosphamide) or other immunosuppressive drugs, hospitalization, or death due to lupus (Major SLE flare); reduce antibodies to double-stranded DNA (dsDNA); and to assess safety compared with placebo in the intent-to-treat population and in patients with impaired renal function at baseline. The intent-to-treat population was defined as patients with high-affinity antibodies to Riquent. The trial was designed to compare the effect of drug or placebo treatment in two well-balanced groups of lupus patients with a history of renal disease. Additional information follows in the section titled Trial Design.

Summary of Results

Intent-to-treat analysis: Riquent appeared to be well tolerated with no apparent differences in the overall incidence of serious adverse events or adverse events between Riquent-treated and placebo-treated patients. However, an initial assessment of the trial data indicates that treatment with Riquent did not increase length of time to renal flare, the primary endpoint, in a statistically significant manner when compared with placebo through the end of the study. There were 298 patients in the intent-to-treat population, 145 on Riquent and 153 on placebo. Patients were treated for as long as 92 weeks with a median of 46 weeks.<snip>

and

NicOx:

UPDATE 2-AstraZeneca, NicOx pain drug fails key test
Tue February 18, 2003 07:21 AM ET
(Adds NicOx downgrades, further analyst comments)By Ben Hirschler, European
Pharmaceuticals Correspondent
LONDON, Feb 18 (Reuters) - A new pain drug designed to cause fewer ulcers
than conventional medicines failed to show significant benefits in a key
clinical test, developer AstraZeneca Plc AZN.L said on Tuesday.
The drug, known by the codename AZD3582 and licensed from French firm NicOx