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March 19, 2014
08:08 EDTCELG, AGIOAgios Pharmaceuticals enrolls first patient in Phase 1 AG-120 study
Agios Pharmaceuticals (AGIO) announced that the first patient has been dosed in a Phase 1 study of AG-120 in patients with advanced hematologic malignancies with an isocitrate dehydrogenase-1 mutation. AG-120 is an orally available, selective, potent inhibitor of the mutated IDH1 protein, making it the first targeted therapeutic candidate to treat patients with cancers that harbor the IDH1 mutation. AG-120 is a part of Agios’ global strategic collaboration with Celgene (CELG). The Phase 1, multicenter, open-label, dose-escalation clinical trial of AG-120 is designed to assess the safety and tolerability of AG-120 as a single agent. The study is expected to only enroll subjects with an IDH1-mutant hematologic malignancy, including acute myelogenous leukemia and myelodysplastic syndrome. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity. Disease-specific expansion cohorts will be enrolled at the maximally tolerated or biologically relevant dose.
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November 21, 2014
06:04 EDTCELGCelgene receives positive CHMP opinion for OTEZLA
Celgene announced that the European Medicines Agency’s, or EMA, Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for OTEZLA, the company’s oral selective inhibitor of phosphodiesterase 4, or PDE4, in two therapeutic indications, for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light, or PUVA; alone or in combination with Disease Modifying Antirheumatic Drugs, or DMARD, for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
November 20, 2014
08:03 EDTAGIOAgios Pharmaceuticals price target raised to $124 from $90 at Leerink
Leerink raised its price target for Agios Pharmaceuticals shares to $124 after the company presented initial data from AG-120 in acute myeloid leukemia that showed "robust activity." Leerink views Agios as an "interesting name" for 2015 with solid tumor data on AG-120 and keeps an Outperform rating on the stock.
November 19, 2014
09:39 EDTCELGCelgene management to meet with ISI Group
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09:16 EDTAGIOOn The Fly: Pre-market Movers
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09:02 EDTAGIOAgios Pharmaceuticals to host conference call
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08:18 EDTAGIOAgios Pharmaceuticals price target raised to $111 from $97 at Canaccord
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November 18, 2014
18:05 EDTAGIOAgios Pharmaceuticals reports early Phase 1 data from AG-120 trial
Agios Pharmaceuticals announced the first reported safety and clinical activity for AG-120 from the ongoing Phase 1 dose escalation study in patients with IDH1-mutant positive advanced hematologic malignancies, including acute myeloid leukemia. Agios has exclusive U.S. development and commercial rights to AG-120, a first-in-class, oral, selective, potent inhibitor of the mutant IDH1 enzyme. Daniel Pollyea, M.D., clinical investigator at the University of Colorado School of Medicine, will present the data in a late-breaking oral presentation at the 26th Annual EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held in Barcelona, Spain. The company will webcast an investor conference call from the symposium at 10:00 a.m. EST on Wednesday, November 19. As of October 17, the ongoing Phase 1 trial for AG-120 had enrolled 17 patients with a documented IDH1 mutation whose cancer relapsed or failed to respond to at least one prior treatment regimen. At the time of the data cut, 14 patients with relapsed and/or refractory AML were evaluable; three patients recently initiated therapy and were not evaluable. The initial data showed investigator assessed objective responses in seven out of 14 evaluable patients, including four complete remissions, with responses observed across the four dose levels tested, and early evidence of durability. One additional patient remains stable on study. AG-120 was well tolerated, with the majority of adverse events reported as mild to moderate. The maximum tolerated dose has not yet been reached. One patient had a dose limiting toxicity of asymptomatic grade 3 QT prolongation at the highest dose tested to date, which improved to grade 1 after AG-120 dose reduction according to treatment protocol. This patient is in complete remission and remains on AG-120. AG-120 showed favorable drug exposure and pharmacokinetics at all doses tested and also substantially reduced plasma levels of the oncometabolite 2-hydroxyglutarate, which is produced by the mutant IDH1 protein, to the level observed in healthy volunteers. The mechanism of response is consistent with differentiation, as evidenced by the maturation of the leukemic cells into infection fighting white blood cells, or neutrophils. Based on these findings, the company plans to initiate multiple expansion cohorts in the first half of 2015.
07:34 EDTCELGCelgene presents long-term OTEZLA data at ACR/ARHP meeting
Celgene announced that results from long-term efficacy and safety analyses of OTEZLA from the open-label phase of two PALACE phase III clinical trials were presented at the 2014 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in Boston. OTEZLA is the Company’s oral, selective inhibitor of phosphodiesterase 4, approved by the U.S. FDA for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In PALACE 1, 84 percent of patients who completed one year of 30 mg twice daily therapy continued to receive OTEZLA at two years. Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving OTEZLA 30 mg twice daily, the ACR20 response rate was 65.3 percent. ACR50 and 70 response rates were 34.0 percent and 19.6 percent, respectively, at week 104. Similar findings were observed in PALACE 4. In this trial, nearly 84 percent of DMARD-naïve patients who completed one year of OTEZLA 30 mg twice daily monotherapy continued to receive OTEZLA at two years. At week 104, among patients treated with OTEZLA 30 mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4 percent, 40.7 percent and 19.2 percent of patients, respectively. In both PALACE 1 and PALACE 4, changes in other efficacy measures—including the HAQ-DI, which assesses improvements in physical function, and swollen and tender joint counts—were also generally sustained between weeks 52 and 104 with continued OTEZLA treatment. In PALACE 4, treatment with OTEZLA in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.
07:20 EDTAGIOEuro Organization for Research & Treatment of Cancer co-hosts a symposium
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November 17, 2014
07:16 EDTCELGMilken Institute--Faster Cures to hold a conference
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