Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Incyte (INCY) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (3056)	12/9/2014 8:30:11 AM
From: nigel bates	Respond to of 3202

INDIANAPOLIS, Dec. 9, 2014 /PRNewswire/ -- Eli Lilly and Company ( LLY) and Incyte Corporation ( INCY) today announce that the Phase 3 RA-BEACON study of the investigational medicine baricitinib met its primary endpoint of improved ACR20 response compared to placebo after 12 weeks of treatment. The study included patients with moderately-to-severely active rheumatoid arthritis (RA) who previously failed one or more tumor necrosis factor (TNF) inhibitors and who were taking stable doses of conventional disease-modifying anti-rheumatic drug (cDMARD) therapy. The companies will share results of several ongoing Phase 3 studies in various disclosures in 2015. "People with rheumatoid arthritis who have had an inadequate response to TNF inhibitors are generally considered to be the least responsive to subsequent treatments," said David Ricks, Lilly senior vice president, and president, Lilly Bio-Medicines. "These results give us further confidence in the potential for baricitinib to be a meaningful treatment option for those suffering from this debilitating condition." "We are very pleased by these results," said Rich Levy, M.D., chief drug development and medical officer, Incyte Corporation. "Over the next 12 months we look forward to seeing the data from additional Phase 3 studies of baricitinib in rheumatoid arthritis, including patients who have had an inadequate response to conventional DMARDs and in those with earlier stage disease." The RA-BEACON study enrolled 527 patients who had previously failed at least one anti-TNF therapy, and included a high percentage who had also received prior treatment with one or several non-anti-TNF biologic agents. Patients received either 1 of 2 doses of once daily baricitinib or placebo in addition to their background conventional disease-modifying anti-rheumatic drug therapy (cDMARDs). The incidence of serious adverse events with baricitinib treatment, including serious infections, was similar to placebo. There were no opportunistic infections or gastrointestinal perforations in the study. A higher incidence of treatment-emergent adverse events was observed with baricitinib compared to placebo. The most common adverse events observed with baricitinib were headache, upper respiratory tract infection and nasopharyngitis. Discontinuation rates due to adverse events were similar between treatment groups. A large majority of patients completing this 6-month trial opted to participate in a long-term extension study. Detailed data from the RA-BEACON study will be presented at scientific meetings in 2015. Lilly and Incyte are evaluating the safety and efficacy of baricitinib in an extensive Phase 3 program with a total enrollment of over 3,000 people with rheumatoid arthritis.

To: scaram(o)uche who wrote (3056)	12/9/2014 11:55:24 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 3202

finance.yahoo.com Tue, Dec 9, 2014, 11:54AM EST Infinity Reports New Results from Phase 1 Study of Investigational Oncology Compound Duvelisib at the American Society of Hematology Annual Meeting – Updated Data from Phase 1 Study Show Duvelisib Activity as a Monotherapy in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma and Relapsed/Refractory T-Cell Lymphoma – (snip, some tox issues and no testimonial to the miracles of gamma inhibition) finance.yahoo.com Tue, Dec 9, 2014, 11:53AM EST Interim Data From Phase 1 Dose Escalation Clinical Trial of TGR-1202, the Once-Daily PI3K Delta Inhibitor, Demonstrates Significant Clinical Activity and Lack of Hepatic Toxicity in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma 93% (13/14) of evaluable CLL patients treated at dose levels >= 800mg of original formulation or any dose of the micronized formulation achieved a > 50% reduction in nodal size (a nodal PR) and 50% (7/14) achieved a partial response per iwCLL (Hallek 2008) criteria 100% (6/6) of CLL and iNHL patients achieving TGR-1202 drug concentrations above 4,000ng/ml responded at the first or second efficacy assessment with at least a nodal PR for CLL or PR for iNHL; Expansion cohorts now open at 800mg QD for CLL and 1200mg QD for iNHL, the dose level that appears to provide patients (3/3) with drug concentrations > 4,000ng/ml No drug related hepatic toxicity or colitis observed with 55 patients treated to date and median time on study of approximately 6 months and some patients on study for over 1.5 years TGR-1202 has been well-tolerated with no dose-related trends in adverse events observed and no MTD reached to date, dose escalation continues now at 1800mg QD (snip)