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Industry News - April 2015

Posted By Connections Editor, Friday, May 1, 2015
Updated: Tuesday, April 28, 2015

FDA Grants Breakthrough Therapy Designation to LentiGlobin for Treatment of Beta-Thalassemia Major
bluebird bio, Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to LentiGlobin® BB305 Drug Product for the treatment of transfusion-dependent patients with beta-thalassemia major. 

ACGT Surpasses $25 Million Funding Milestone with Two New Grants
Alliance for Cancer Gene Therapy (ACGT) has achieved a major milestone, surpassing $25 million donated to innovative and breakthrough cancer research.

Europe Approves Holoclar®, the First Stem Cell-Based Medicinal Product|
The European Commission has granted a conditional marketing authorization, under Regulation (EC) No 726/2004, to Holoclar®, an advanced therapy based on autologous stem cells and capable to restore the eyesight of patients with severe cornea damage. 

T-Cell Therapy Clinical Trial Now Offered to Cancer Patients at C.S. Mott Children’s Hospital
A clinical trial using T-cell therapy that uses the patients’ own immune cells to hunt down cancer cells is now being offered at the University of Michigan’s C.S. Mott Children’s Hospital.

Medigene Starts Phase I/II Study with DC Vaccine to Treat Acute Myeloid Leukemia (AML)
Medigene AG announced that the company’s Phase I/II clinical trial with its dendritic cell vaccine for the treatment of AML has started.

Immunovaccine Initiates Phase II Clinical Trial of DPX-Survivac Immunotherapy in Recurrent Lymphoma
Immunovaccine Inc. announced that it has treated the first patient with diffuse large B cell lymphoma in a Phase II clinical study of its lead cancer immunotherapy DPX-Survivac. 

ESPERITE (Euronext ESP) Pioneers First Treatment Worldwide of Cerebral Palsy Using Two Types of Stem Cells
CryoSave, part of ESPERITE, leads and sponsors a multicentre clinical trial following GCP-ICH standards, for investigation of new treatment of Cerebral Palsy using dual infusion of two types of stem cells derived from umbilical cord blood and cord tissue processed by CryoSave

AOP Orphan Pharmaceuticals Announces Progress of Pivotal Phase III Trial PROUD-PV Applying Ropeginterferon Alfa 2b, a Novel, Long-Acting, Mono-Pegylated Interferon for Treatment of Polycythemia Vera
AOP Orphan Pharmaceuticals AG reported the completion of recruitment for its Phase III trial PROUD-PV to support global licensure of Ropeginterferon alfa 2b, a novel, long-acting, mono-pegylated Interferon for the treatment of Polycythemia Vera.

Sangamo BioSciences Announces FDA Acceptance of IND to Initiate Clinical Trial of its Novel ZFP Therapeutic® for Beta-Thalassemia
Sangamo BioSciences, Inc. announced that an Investigational New Drug application for the company’s SB-BCLmR-HSPC genome editing approach, which is designed to provide a one-time lasting therapy for beta-thalassemia, has been accepted by the U.S. Food and Drug Administration and is now active. 

IMBRUVICA® (Ibrutinib) Treatment Shows Efficacy and Tolerability in Heavily Treated Chronic Lymphocytic Leukemia Patients following Allogeneic Stem Cell Transplant
Pharmacyclics, Inc. announced that treatment with IMBRUVICA® was associated with an 88% overall response rate, with a median time on study of 23.3 months, in 16 patients with relapsed/refractory high-risk chronic lymphocytic leukemia. 

MEI Pharma Announces Top-Line Data from Randomized Phase II Clinical Study of Pracinostat in Front-Line Myelodysplastic Syndrome
MEI Pharma, Inc. announced top-line data from a randomized Phase II clinical study of its investigational drug candidate Pracinostat in combination with azacitidine in patients with previously untreated intermediate-2 or high-risk myelodysplastic syndrome. 

Cellerant Announces Dosing of First Patient in Randomized Phase II Clinical Trial of CLT-008 in Acute Myeloid Leukemia Patients
Cellerant Therapeutics Inc. announced that patient dosing has commenced in its multi-center, open-label, randomized controlled Phase II clinical trial of CLT-008, a first-in-class, allogeneic, cellular therapy, in de novo acute myeloid leukemia patients receiving induction chemotherapy.

UW to Test ‘Breakthrough’ Pediatric Leukemia Treatment
A promising method of immunotherapy to treat children with relapsed acute lymphocytic leukemia (ALL) is opening at the University of Wisconsin Carbone Cancer Center and American Family Children’s Hospital. The trial is open to relapsed/refractory pediatric ALL patients who have limited treatment options. 

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