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January 30, 2014
05:37 EDTCTICCTI announce UK National Cancer Research Institute Phase 2 trial for Pacritinib
Cell Therapeutics announced the initiation of an international cooperative group Phase 2 clinical trial of pacritinib in adult patients with relapsed acute myeloid leukemia, or AML, with mutations of the FLT3 gene. Mutation of the FLT3 gene is found in approximately one-third of AML patients and is an independent risk factor for poor prognosis. Pacritinib is an oral JAK2/FLT3 inhibitor that has demonstrated encouraging activity in preclinical models of AML with mutated FLT3 gene, including additional FLT3 mutations that confer resistance to other targeted FLT3 agents. The trial is being conducted by the AML Working Group of the National Cancer Research Institute Haematological Oncology Study Group in AML and high risk Myelodysplastic Syndrome under the sponsorship of Cardiff University and supported by Cancer Research UK. This Phase 2 trial is part of a larger ongoing study in AML, referred to as the AML17 trial, which includes multiple arms evaluating first line regimens for AML. Patients with the FLT3 mutation, who are enrolled in this study and relapse following standard therapy, will be offered therapy with pacritinib. Approximately 80 patients at sites in England and Wales will be enrolled and, if an encouraging response rate is observed, a pacritinib arm may be adopted in the first line therapy study.
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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.

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