Navigation Links
Rigel's R788 Phase 2a Results Published in Arthritis and Rheumatism
Date:11/11/2008

First of Phase 2b studies completes patient screening for enrollment

SOUTH SAN FRANCISCO, Calif., Nov. 11 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the previously reported results of the Phase 2 clinical trial of R788 (fostamatinib disodium), the company's oral Syk inhibitor, have been published in the November 2008 issue of Arthritis and Rheumatism. The article, entitled, "Treatment of rheumatoid arthritis with a syk kinase inhibitor: A twelve-week, randomized, placebo-controlled trial" was written by Michael E. Weinblatt, M.D., et al.

The investigators for this study, also called TASKi1, which enrolled 189 patients with active rheumatoid arthritis (RA) already taking methotrexate for their disease, found that the 100 mg and 150 mg doses of R788 showed rapid and significant improvement in patient outcomes as measured by ACR 20, ACR 50 and ACR 70 response scores. The adverse events reported were manageable and, in large part, reversible by reduced dosing or stoppage of drug. The investigators concluded that R788 may offer a new therapeutic option for patients with RA and that additional clinical studies were warranted.

Phase 2b update

In June 2008, Rigel initiated two Phase 2b trials of R788 in patients with RA, TASKi2 and TASKi3, to further explore the safety and efficacy of the drug candidate in a larger number of patients over a longer time period in multiple centers in North America, Latin America and Europe. "At this time, we are pleased to report that we have successfully completed patient screening for enrollment in TASKi2 and are proceeding with both Phase 2b trials on schedule," commented Elliott Grossbard, M.D., executive vice president and chief medical officer of Rigel. Results from both studies are expected to be available in late summer 2009.

TASKi2 will evaluate RA patients receiving 100 mg of R788 orally, twice a day or 150 mg once a day, compared with those receiving placebo in a multi- center, randomized, double blind, placebo controlled parallel dose study of RA patients who have failed to respond to methotrexate. TASKi2 will enroll 420 patients (all of whom have been identified) to receive study drug or placebo, along with their steady dose of methotrexate, over a 6 month treatment period.

TASKi3 will evaluate RA patients receiving 100 mg of R788 orally, twice a day, compared with those receiving placebo in a multi-center, randomized, double blind, placebo controlled, parallel dose study of R788 in patients who have failed at least one marketed biologic agent (i.e., anti-TNF injectibles commonly used to treat RA). Approximately 195 patients are expected to be enrolled in TASKi3. Each will receive R788 or placebo over a 3 month treatment period.

For more information about the TASKi studies and R788's mechanism of action in RA and other autoimmune disorders, please visit the company's website.

About Rigel (http://www.Rigel.com)

Rigel is a clinical-stage drug development company that discovers and develops novel, small-molecule drugs for the treatment of inflammatory/autoimmune diseases and cancer, as well as viral and metabolic diseases. Our pioneering research focuses on intracellular signaling pathways and related targets that are critical to disease mechanisms. Rigel's productivity has resulted in strategic collaborations with large pharmaceutical partners to develop and market our product candidates. Rigel has product development programs in inflammatory/autoimmune diseases such as rheumatoid arthritis, thrombocytopenia and asthma, as well as in cancer.

This press release contains "forward-looking" statements, including statements relating to the potential efficacy of R788, enrollment rate in trials, as well as Rigel's plans to pursue clinical development of R788. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "plans," and "expected," and similar expressions are intended to identify these forward-looking statements. There are a number of important factors that could cause Rigel's results to differ materially from those indicated by these forward looking statements, including risks associated with the timing and success of clinical trials and the commercialization of product candidates, potential problems that may arise in the clinical testing and approval process and Rigel's need for additional capital, as well as other risks detailed from time to time in Rigel's SEC reports, including its Form 10-Q for the quarter ended September 30, 2008. Rigel does not undertake any obligation to update forward-looking statements.

Contact: Raul Rodriguez

Phone: 650.624.1302

Email: rrodriguez@rigel.com

Media Contact: Susan C. Rogers, Alchemy Consulting, Inc.

Phone: 650.430.3777

Email: susan@alchemyemail.com


'/>"/>
SOURCE Rigel Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint
2. Anesiva Announces Adlea ACTIVE-1 Phase 3 Clinical Results, Ceasing of Zingo Commercial Operations and Restructuring
3. Raptor Pharmaceuticals to Collaborate with Centre Hospitalier Universitaire dAngers for Phase II Clinical Trial in Huntingtons Disease
4. VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease
5. Patient Recruitment Begins in India for Phase 3 Diabetes Trial
6. Portola Announces Data Presentations Relevant to Its Lead Phase II Antithrombotic Compounds at American Heart Association Scientific Sessions 2008
7. Poniard Pharmaceuticals Announces Final Top-Line Results from Phase 1 Trial Demonstrating Positive Bioavailability with Oral Picoplatin
8. Bavarian Nordic Reports Successful Safety Data From Phase II Study With IMVAMUNE(R)
9. VIA Pharmaceuticals Announces Conference Call and Webcast to Discuss VIA-2291 Phase 2 Data Presentations at AHA
10. Bionovo Advances BZL101 to Phase 2 Clinical Trials After Positive Phase 1 Results for Metastatic Breast Cancer
11. MedImmune Advances Pediatric Disease Prevention Program With Start of Phase 1/2a Clinical Trial for Respiratory Syncytial Virus Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/16/2017)... Datascope Corp. is voluntarily performing a worldwide field correction of certain ... failure code.     ... PART NUMBER ... 0998-UC-0446HXX; 0998-UC-0479HXX 0998-00-3013-XX;  0998-UC-3013-XX ... This field correction also applies to any ...
(Date:6/14/2017)...  ivWatch LLC, a medical device company focused on ... is pleased to announce it was the Bronze Winner ... and Equipment at the 2017 Medical Design Excellence Awards ... The award was presented by Medical Device and Diagnostics ... New York during MD&M East, ...
(Date:6/14/2017)... N.C. , June 14, 2017  In 2016, ... Creative Startups pitch competition and came away ... reality platform is described by Forbes as "entering the ... American Medical Association as teaching "empathy to medical professionals ... the startup was recently named a finalist for the ...
Breaking Medicine Technology:
(Date:6/28/2017)... (PRWEB) , ... June 28, 2017 , ... ... consulting firm servicing communities throughout the greater Cincinnati metropolitan area, is teaming up ... temporary lodgings for families with children receiving treatment in nearby hospitals. , Ronald ...
(Date:6/27/2017)... and London UK (PRWEB) , ... June 27, 2017 , ... ... to a clinical study is whether they can trust the sponsor to pay them ... is vital that sponsors and CROs establish payment strategies that encourage sites to work ...
(Date:6/27/2017)... (PRWEB) , ... June 27, 2017 , ... The Congressional ... bill to repeal and replace the 2010 Patient Protection and Affordable Care Act (ACA), ... with what would be expected under current law. , More than 20 million Americans ...
(Date:6/27/2017)... (PRWEB) , ... June 27, 2017 , ... A January ... been projected to reach a staggering $6.81 billion by the year 2024 according to ... at a faster rate than those made from titanium. Los Angeles area clinic Beverly ...
(Date:6/27/2017)... ... June 27, 2017 , ... PR News is ... case studies guidebook. This guidebook offers an excellent branding and exposure opportunity for ... case studies and how-to’s that fall into the following categories:, ...
Breaking Medicine News(10 mins):