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June News Roundup

Posted By Connections Editor, Wednesday, June 25, 2014

First volunteers to receive blood cultured from stem cells in 2016

Red blood cells cultured in a laboratory will be trialed in human volunteers for the first time within the next three years, as part of a long-term research program funded by the Wellcome Trust. The £5 million Strategic Award was granted to a consortium led by the Scottish National Blood Transfusion Service, and will follow on from previous research that proved that red blood cells could be generated from stem cells.


Alnylam Reports Initial Positive Top-Line Data from Phase I Clinical Trial with ALN-AT3, an RNAi Therapeutic Targeting Antithrombin (AT) in Development for the Treatment of Hemophilia and Rare Bleeding Disorders (RBD)

Alnylam Pharmaceuticals, Inc. announced positive top-line results from its ongoing Phase I trial of ALN-AT3, a subcutaneously administered RNAi therapeutic targeting AT in development for the treatment of hemophilia and RBD.


Umbilical Cord Stem Cell Therapy Clinical Trial for Multiple Sclerosis Gets Green Light

Translational Biosciences, a subsidiary of Medistem Panama, has received the green light for a phase I/II clinical trial using human umbilical cord-derived mesenchymal stem cells for multiple sclerosis from the Comité Nacional de Bioética de la Investigación Institutional Review Board .


Clinical Trial Investigates Cord Blood Stem Cells to Treat Cerebral Palsy in Children

Cord Blood Registry® announces the launch of an FDA-regulated clinical trial being conducted at The University of Texas Health Science Center at Houston to investigate two forms of stem cell therapy in children diagnosed with cerebral palsy. The randomized, placebo-controlled study aims to compare the safety and efficacy of an intravenous infusion of cord blood stem cells to bone marrow stem cells.


Emmaus Life Sciences Announces Positive Top-Line Results of Its Phase III Clinical Trial For Sickle Cell Disease

Emmaus Life Sciences, Inc. announced that preliminary top-line results of its Phase III clinical trial evaluating the safety and efficacy of its treatment for sickle cell anemia and sickle beta-0 thalassemia met both the primary and secondary endpoints of the clinical trial.


bluebird bio Announces First Patient Transplanted in Phase I/II Northstar Study for the Treatment of Beta-Thalassemia

Bluebird bio, Inc. announced that the first subject with beta-thalassemia major has been enrolled in its Phase I/II Northstar Study (HGB-204) in the United States and has undergone infusion with bluebird bio’s LentiGlobin drug product in an autologous hematopoietic stem cell transplantation.


Ambit Announces Initiation of Phase II Cohort in MD Anderson Sponsored Study of Quizartinib in AML and High Risk MDS

Ambit Biosciences announced the initiation of the Phase II cohort of the MD Anderson Cancer Center-sponsored Phase I/II study of quizartinib in combination with either 5-azacitidine or low dose cytarabine for previously untreated FLT3-ITD positive acute myeloid leukemia (AML) patients age 60 or older, or FLT3-ITD positive AML patients 18 years of age or older in first relapse.


Moffitt Cancer Center’s Phase III Study May Be Game-Changer for Acute Myeloid Leukemia

Moffitt Cancer Center researchers say clinical trials for a new experimental drug to treat acute myeloid leukemia are very promising. Patients treated with CPX-351, a combination of the chemotherapeutic drugs cytarabine and daunorubicin, are showing better responses than patients treated with the standard drug formulation.


PIXUVRI® Launched in UK for Adult Patients with Multiply Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

Cell Therapeutics, Inc. announced the launch of PIXUVRI® (pixantrone), the first new treatment for adult patients in the United Kingdom with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

GSK and Genmab Receive FDA Approval for Arzerra® (Ofatumumab) as First-Line Treatment in Combination with Chlorambucil for Patients with Chronic Lymphocytic Leukemia (CLL) for Whom Fludarabine-Based Therapy Is Considered Inappropriate

The FDA approval of the first-line indication is based on results from a Phase III study (COMPLEMENT 1) which demonstrated statistically significant improvement in median progression-free survival in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.


Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration  has granted the investigational PD-1 immune checkpoint inhibitor nivolumab Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab.


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