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News Roundup: August 2013

Posted By Connections Editor, Monday, September 09, 2013
Updated: Thursday, August 22, 2013

Spanish scientists successfully generate 'artificial bones' from umbilical cord stem cells
Scientists in Granada, Spain, have patented a new biomaterial that facilitates generating bone tissue—artificial bones in other words—from umbilical cord stem cells . The material, consisting of an activated carbon cloth support for cells that differentiate giving rise to a product that can promote bone growth, has recently been presented at a press conference at the Biomedical Research Centre, Granada.

Stem Cell Agency’s Board Approves $70 Million Plan to Develop Innovative Alpha Clinics
A $70 million plan to create a new statewide network of sites that will act as a hub for stem cell clinical trials was approved by the governing Board of California’s stem cell agency, the California Institute for Regenerative Medicine (CIRM).

Scéil™: a new offering for the general public to turn adult cells into stem cells and store them
The Cellectis Group announced today that it is launching Scéil™, an offering for the general public that involves storing induced pluripotent stem cells (iPS) generated from a skin sample so that people can benefit, if needed, from future regenerative medicine treatments as soon as they become available.

BioLineRx Enrolls First Patient in Phase 2 Clinical Trial for BL-8040, for Treatment of Leukemia
BioLineRx, a biopharmaceutical development company, announced enrollment of the first patient in a Phase 2 trial for BL-8040, for the treatment of acute myeloid leukemia (AML).

New sickle cell anemia therapy advances to phase II clinical trials
Seeking to improve the lives of sickle cell anemia sufferers around the world, researchers from the La Jolla Institute for Allergy and Immunology, the Dana-Farber/Children's Hospital Cancer Center in Boston and the BloodCenter of Wisconsin in Milwaukee and others are preparing to launch Phase II of a clinical trial to investigate a potential new therapy for reducing the disorder’s severest symptoms.

FDA puts Cell Therapeutics blood cancer drug on hold after death
Cell Therapeutics Inc said the U.S. Food and Drug Administration has placed a partial clinical hold on the company's experimental blood cancer drug after the death of a patient.

MEI Pharma Initiates Phase II Clinical Trial of Pracinostat and Vidaza® in Frontline Myelodysplastic Syndrome
MEI Pharma, Inc. announced that the first patients have been dosed in a Phase II clinical trial of its lead drug candidate Pracinostat in combination with Vidaza (azacitidine) in patients with previously untreated intermediate-2 or high-risk myelodysplastic syndrome (MDS).

Market Access Granted in Italy for Aggressive non-Hodgkin Lymphoma Treatment, PIXUVRI® (pixantrone)
Cell Therapeutics, Inc. (CTI) announced that the Company has been granted market access by the Italian Medicines Agency (AIFA) for the medicinal product PIXUVRI® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressiveB-cell non-Hodgkin lymphoma (patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy).

FDA grants Roche’s obinutuzumab (GA101) Priority Review for previously untreated chronic lymphocytic leukemia (CLL)
Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for obinutuzumab (GA101) and granted Priority Review for GA101 in the treatment of chronic lymphocytic leukemia (CLL), one of the most common forms of blood cancer, based on final stage 1 data from the pivotal CLL11 trial.

Celgene Will Discontinue Phase III ORIGIN® Trial in Previously Untreated Elderly Patients with B-Cell Chronic Lymphocytic Leukemia
Celgene Corporation announced that after consultation with the U.S. Food and Drug Administration (FDA) Celgene will discontinue treatment with REVLIMID® (lenalidomide) in the open-label, phase III ORIGIN® trial, which enrolled 450 patients in over 100 sites in 26 countries.

Roche's obinutuzumab (GA101) delayed disease progression longer than MabThera/Rituxan in people with one of the most common forms of blood cancer
Roche announced positive results from the phase III CLL11 study. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint showing that GA101 plus chlorambucil helped people live significantly longer without their disease worsening (progression-free survival; PFS) compared to MabThera/Rituxan plus chlorambucil.

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