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June 17, 2014
08:13 EDTMRTXMirati Therapeutic' mocetinostat granted ODD by FDA as treatment for MDS
Mirati Therapeutics announced that mocetinostat, the company's spectrum selective HDAC inhibitor, has been granted Orphan Drug Designation, or ODD, by the FDA as a treatment for myelodysplastic syndrome, or MDS. Mocetinostat is being developed in Phase 2 clinical studies in combination with Vidaza as a treatment for intermediate and high-risk MDS, as well as a single agent treatment in patients with diffuse large B-cell lymphoma and bladder cancer targeting specific genetic mutations in histone acetylation that increase the likelihood of response in tumor cells.
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September 28, 2015
08:05 EDTMRTXMirati Therapeutics presents interim clinical data from ongoing MGCD516 study
Mirati Therapeutics announced it presented data from the study titled, "A First-in-Human Phase 1/1b Study of Receptor Tyrosine Kinase Inhibitor, MGCD516, in Patients with Advanced Solid Tumors" at the 2015 European Cancer Congress in Vienna, Austria. The objective of the dose escalation phase of the study, in unselected patients, is to characterize the safety of MGCD516, determine a Phase 2 dose and establish the maximum tolerated dose. MGCD516 is orally administered to unselected patients with advanced solid tumors once daily (QD) on a 21-day cycle. The study is exploring escalating doses of 10 mg, 20 mg, 40 mg, 80 mg, 110 mg, 150 mg and 200 mg, with twenty-eight patients enrolled to date. The 200 mg dose level is currently being evaluated. MGCD516 was well tolerated, with the most frequently reported adverse events being fatigue, diarrhea, cough, hypertension, nausea and vomiting. The only dose limiting toxicity seen to date was grade 3 Palmar-Plantar Erythrodysesthesia in one patient at the 80 mg dose. No DLTs were observed at the 110 mg and 150 mg doses. PK/PD data indicate MGCD516 is achieving serum levels associated with tumor inhibition seen in preclinical models.

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