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Rigel's R348 to Initiate Phase 2 Clinical Trial in Dry Eye
Date:5/22/2013

causing the symptoms of this condition.  A recently completed Phase 1 study of R348 in patients with dry eye disease showed that the drug candidate is well tolerated and Rigel expects to begin a Phase 2 study, titled DROPS (Dry eye Rigel Ophthalmic Phase 2 Study), shortly.  This multi-center, randomized, double-masked study, will evaluate two doses of R348 versus placebo administered twice a day over a three-month period in approximately 210 patients with dry eye disease.  The efficacy endpoints will include change from baseline in corneal staining, tear production and dry eye symptom scores.  Results of this Phase 2 study are expected in the first half of 2014.

R428/BGB324 AXL Kinase Inhibitor- BerGenBio
In June 2011, Rigel and Norway's BerGenBio entered into an agreement for Rigel's preclinical candidate, R428, which is an orally bioavailable and selective AXL kinase inhibitor.   Now called BGB324, this AXL kinase inhibitor is expected to be useful in the treatment of hematological and certain solid tumor cancers, including leukemia, pancreatic, and breast cancers.  AXL kinase expression by cancer cells is essential to metastatic dissemination and is linked with increasing resistance to current cancer therapeutics.  By inhibiting AXL kinase expression, BGB324 has been shown, in preclinical studies, to be effective as a single agent therapeutic in preventing and reversing acquired resistance to standard of care cytotoxics and targeted therapies, and may also slow or prevent tumor metastasis.   BerGenBio has filed an IMPD (IND-equivalent) and intends to conduct the first-in-human studies of BGB324 in Europe.

Ubiquitin Ligase Inhibitor – Daiichi Sankyo
Rigel and Daiichi Sankyo have a collaboration aimed at identifying small molecule drug candidates against a ligase target that controls cancer cell proliferation through pro
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SOURCE Rigel Pharmaceuticals, Inc.
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