Hi Bernard,
Could you, or anyone else, comment on the speed with which this Phase I trial is being done. It strikes me as being rather fast from announcement of the plan to presentation of the results within about 4 months.
Or is that the norm for safety stuff????
Thanks,
Ian.
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Scios Announces Start of Phase Ib Clinical Trial of SCIO-469
SUNNYVALE, Calif., Feb 7, 2001 /PRNewswire via COMTEX/ -- Scios Inc. (Nasdaq: SCIO) announced today that the company has initiated a Phase Ib, double-blind, placebo-controlled, multiple oral dose study of SCIO-469, its proprietary oral p38 kinase inhibitor for the treatment of Rheumatoid Arthritis (RA). The purpose of the study is to determine the safety, tolerability and pharmacokinetics of multiple oral doses of SCIO-469. The Phase Ib trial will enroll 20 healthy volunteers who will each be dosed multiple times over a two-week period. Scios expects to announce the results of this trial in the second quarter of 2001.
"This trial follows our recently completed Phase Ia dose-ranging study in which volunteers received single doses of SCIO-469," said George Schreiner, M.D., Ph.D., Scios' chief scientific officer. "In addition to establishing the safety and tolerability of our compound over a longer period of time, the pharmacokinetic information obtained in this trial will help us establish the optimal dose and regimen for the Phase II trial that we plan to begin in the fourth quarter of this year."
Scios recently completed a Phase Ia trial of SCIO-469 in which single oral doses were shown to be safe and well tolerated. The Phase Ia trial enrolled 30 volunteers.
"The extremely rapid pace with which SCIO-469 is progressing through clinical trials is a result of the focused approach of Scios' development team," said Patricia A. Baldwin, Ph.D., vice president of quality and product development. "The clinical data thus far confirm SCIO-469 is a potent and highly selective inhibitor of p38 kinase. We are on an aggressive timeline with this priority development project and believe this will emerge as an important addition to our growing pipeline."
SCIO-469 is the first product to come from Scios' novel approach to drug discovery. p38 kinase is an intracellular signaling enzyme that is activated by environmental stress or ischemia. p38 kinase stimulates TNF (tumor necrosis factor) production and COX-2 (cyclooxygenase-2) biosynthesis, leading to inflammation. Recent advances in the treatment of RA have been made by antagonizing TNF, markedly relieving the symptoms and retarding the progression of the disease. These treatments are currently administered via injection or infusion. SCIO-469 is an oral treatment, offering a more convenient and tolerable treatment for patients.
Rheumatoid Arthritis is a progressively worsening autoimmune disease of unknown origin in which the body's natural immune system attacks healthy joint tissue causing inflammation and joint damage.
Scios Inc.
Scios is a biopharmaceutical company developing novel treatments for heart failure and rheumatoid arthritis. The company's disease-based technology platform integrates expertise in protein biology with combinatorial and medicinal chemistry to identify novel targets and rationally design protein-based and small-molecule compounds to treat cardiovascular and inflammatory diseases. Additional information about Scios is available at its web site located at www.sciosinc.com and in the company's various filings with the Securities and Exchange Commission.
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. These include uncertainties associated with the successful completion of additional studies with p38 kinase inhibitor, and the results of competing companies attempting to develop or improve other treatments for RA and other inflammatory diseases, as well as other risks detailed from time to time in the reports filed by Scios with the SEC, including the company's annual report on form 10-K for the year ended December 31, 1999 and subsequent reports on form 10-Q.
SOURCE Scios Inc. |
