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July 21, 2014
05:12 EDTCTICCTI BioPharma announces approval of Pixuvri in Israel
CTI BioPharma announced that it has received approval from the Israeli Ministry of Health, or MOH, for Pixuvri. Pixuvri in Israel is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma who have received not more than three previous courses of treatment. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. In Israel, Pixuvri will be distributed and marketed by the Neopharm Group, Israel's second largest pharmaceuticals and health products marketer, once Pixuvri is included in the Israeli National Health Basket of drugs by the MOH. Separately, the Dutch Healthcare Authority, or NZa, and the healthcare insurance board College voor zorgverzekeringen, or CVZ, of the Netherlands have approved funding for Pixuvri as an add-on drug for patients who need a third- or fourth-line treatment option for aggressive B-cell lymphoma. This follows the inclusion of Pixuvri on the HOVON, or Haemato Oncology Foundation for Adults in the Netherlands, treatment guidelines, effective June 1. The inclusion on the Dutch list of reimbursed drugs makes Pixuvri the first registered and reimbursed medicine for the treatment of patients with multiply relapsed or refractory aggressive B-cell NHL in the Netherlands.
News For CTIC From The Last 14 Days
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December 9, 2014
05:56 EDTCTICCTI BioPharma presents Pacritinib data at ASH meeting
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December 7, 2014
14:25 EDTCTICCTI BioPharma announces analysis of kinase inhibition by pacritinib
CTI BioPharma announced that an analysis of kinase inhibition by pacritinib, a next generation oral multikinase inhibitor in Phase 3 clinical development, demonstrated a unique kinome profile among agents in development for myelofibrosis and suggests potential therapeutic benefit across a spectrum of blood-related cancers. Researchers presented the findings from this analysis at the 56th American Society of Hematology Annual Meeting and Exposition held December 6-9 in San Francisco, CA."The kinome profile of pacritinib shown in this analysis highlights how pacritinib is different from other JAK inhibitors that are currently on the market and in development for myelofibrosis," said Srdan Verstovsek, M.D., Ph.D., Director, Clinical Research Center for MPNs at The University of Texas MD Anderson Cancer Center and principal investigator for the Phase 3 PERSIST-2 trial of pacritinib. "One of the findings observed in clinical trials to date is the lack of myelosuppression seen with other treatments. Pacritinib's potent inhibition of FLT3, c-fms, IRAK1 and c-kit, all critical targets in hematologic malignancies, highlights its potential therapeutic utility in other indications, such as AML, MDS, CMML and CLL." The in vitro profiling of pacritinib across a panel of kinases showed the inhibition of all members of the JAK/FLT pathways, with the exception of JAK1. The JAK/FLT pathways are frequently dysregulated in many types of cancers. Additionally, pacritinib was found to inhibit the kinases c-fms and IRAK1. Disruption in the c-fms and IRAK1 pathways have been indicated to be involved in acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia and chronic lymphocytic leukemia. CTI believes the clinical efficacy and reduced myelosuppression seen in Phase 2 trials of pacritinib in patients with myelofibrosis is also likely attributable to this unique kinase inhibition profile. "These data not only demonstrate the unique attributes of pacritinib compared to other marketed agents or agents in development for the treatment of myelofibrosis, many of which have activity against JAK1, but also show the potential for broader use in other blood-related cancers," said Jack Singer, M.D., Executive Vice President, Global Medical and Translational Medicine at CTI and lead author of the analysis. "We are excited to pursue additional indications, such as AML, MDS, CMML and CLL, all of which are currently being evaluated in Phase 2 clinical trials, so we can potentially offer these patients an effective and less toxic treatment option."
14:10 EDTCTICAmerican Society of Hematology to hold a meeting
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14:08 EDTCTICCTI BioPharma to hold a cocktail reception
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December 4, 2014
09:23 EDTCTICOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Avago (AVGO), up 7.2%... Kroger (KR), up 3.1%... Rite Aid (RAD), up 3.1%... Sears Holdings (SHLD), up 2.3%. ALSO HIGHER: Array Biopharma (ARRY), up 24% after reaching a definitive agreement with Novartis (NVS) to regain full worldwide rights to binimetinib... Hawaiian Electric (HE), up 13.5% following merger announcement with NextEra Energy (NEE)... SinoCoking Coal (SCOK), up 14.2% after beginning construction of second aboveground Syngas facility... Plug Power (PLUG), up 12.3% after announcing $20M ReliOn fuel cell contract... Mobileye (MBLY), up 3.4% after being upgraded to Buy from Hold at Deutsche Bank... CTI BioPharma (CTIC), up 3.6% following $15M payment from Teva for TRISENOX... TASER (TASR), up 3% after receiving multiple orders of AXON body cameras. DOWN AFTER EARNINGS: Barnes & Noble (BKS), down 7.6%... Express (EXPR), down 11.3%... Toronto-Dominion Bank (TD), down 1.4%... Toro Company (TTC), down 1.1%... Aeropostale (ARO), down 14.1%. ALSO LOWER: Kindred Biosciences (KIN), down 29.3% after announcing that it will discontinue its AtoKin study... UTi Worldwide (UTIW), down 13% after saying that there are no current talks with DSV A/S... Agree Realty (ADC), down 3.7% after 2.1M share Spot Secondary priced at $29.90.
05:30 EDTCTICCTI BioPharma receives $15M payment from Teva for TRISENOX
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