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News Roundup: December 2014

Posted By Connections Editor, Monday, January 5, 2015
Updated: Tuesday, December 30, 2014

bluebird bio Announces First Patient with Sickle Cell Disease Transplanted with LentiGlobin Gene Therapy

bluebird bio, Inc., a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and orphan diseases, announced that the first subject with severe sickle cell disease has undergone infusion with bluebird bio’s LentiGlobin BB305 drug product in an autologous hematopoietic stem cell transplantation.

AgonOx’s OX40 Platform Being Utilized in MedImmune’s Phase I OX40 Agonist Study

AgonOx, a biotechnology company focused on immunotherapy development, announced that its OX40 platform is being utilized in MedImmune’s Phase I trial of its humanized OX40 agonist, MEDI6383. 

Theravectys Provides Update On Its Phase I/Ii Lentiviral Vector-Based Therapeutic Vaccine Trial

THERAVECTYS reports promising preliminary results in the first-ever vaccination trial conducted with lentiviral vectors. The randomized, placebo-controlled trial currently enrolls 38 HIV-positive patients under highly active antiretroviral therapy in 12 clinical sites in France and Belgium and aims at comparing the safety, tolerability and immunogenicity of its therapeutic vaccine candidate at 3 different doses versus placebo.

Bergenbio Receives Orphan-Drug Designation From FDA For BGB324 In The Treatment Of Acute Myeloid Leukaemia

BerGenBio AS  announces that the US Food and Drug Administration has granted orphan-drug designation for BGB324 for treatment of acute myeloid leukaemia (AML). BerGenBio had announced earlier that the first patient has been dosed in its multi-centre Phase 1b trial of BGB324, a selective inhibitor of Axl, in patients with AML. The two part trial will primarily investigate the safety and tolerability of BGB324 when administered as a single agent and in combination with a standard-of-care drug (cytarabine).

Sunesis Announces Results from Pivotal Phase III VALOR Trial of Vosaroxin and Cytarabine in Patients with First Relapsed or Refractory Acute Myeloid Leukemia

Sunesis Pharmaceuticals, Inc. announced results from the pivotal Phase III VALOR trial, a randomized, double-blind, placebo-controlled trial of vosaroxin and cytarabine in patients with first relapsed or refractory acute myeloid leukemia.

IMBRUVICA® (ibrutinib) Now Approved in Europe for Treatment of Two Blood Cancers

Pharmacyclics, Inc. announced that the European Commission has granted marketing approval for IMBRUVICA® (ibrutinib) throughout the 28 member states of the European Union. 

BioLineRx Files Protocol Amendment to Phase II Study for AML Treatment based on Encouraging Efficacy and Strong Safety Profile

BioLineRx Ltd. announced that in light of encouraging pharmacodynamic and excellent safety data from the ongoing Phase II clinical trial of BL-8040 for the treatment of patients with relapsed or refractory acute myeloid leukemia, the Company has filed with the U.S. Food and Drug Administration an amendment to the study protocol to test additional cohorts at higher doses in the current dose-escalation stage of the trial. 

Cell Source's Megadose Drug Combination Receives Regulatory Approval in Italy to Commence Human Clinical Trials

Cell Source, Inc announced its Megadose Drug Combination has been cleared for human clinical trials in Italy. Cell Source's proprietary Megadose Drug Combination is expected to increase bone marrow transplantation success and survival.

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