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News from the Field - February 2015

Posted By Connections Editor , Friday, February 27, 2015
Updated: Monday, February 23, 2015

Stemline Therapeutics Initiates SL-401 Clinical Trial in Four Rare Myeloproliferative Neoplasms
Stemline Therapeutics, Inc. announced the initiation of a clinical trial with SL-401 in four rare myeloproliferative neoplasms .

Unum Therapeutics Announces Start of First Phase I Clinical Trial of Cellular Immunotherapy Targeting CD20+ Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma
Unum Therapeutics announced that recruitment has begun in the first clinical trial of the ATTCK20 therapy. The Phase I study will examine the feasibility, safety and potential efficacy of infusing the ATTCK20 combination therapy in patients with B-cell malignancies and persistent disease following standard therapy.

FDA Approves BLINCYTO™ (Blinatumomab) Immunotherapy for the Treatment of Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
Amgen announced that the U.S. Food and Drug Administration has granted approval of BLINCYTO™ for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

bluebird bio Announces Data Demonstrating First Four Patients with β-Thalassemia Major Treated with LentiGlobin™ Are Transfusion-Free
bluebird bio, Inc. announced data from eight subjects treated with LentiGlobin BB305 drug product. In the first four subjects, each of whom had at least three months of follow up, treatment with LentiGlobin BB305 drug product resulted in sufficient hemoglobin production to reduce or eliminate the need for transfusion support among patients with beta-thalassemia major who would otherwise require chronic blood transfusions.

Fate Therapeutics Announces Interim Data From Ongoing Phase 2 PUMA Study
Fate Therapeutics, Inc. reported initial data from the first 12 subjects administered PROHEMA® in the Company's ongoing Phase 2 PUMA study and announced that the study's independent Data Monitoring Committee supported continuation of the clinical trial following a second planned interim safety review.

Kiadis Pharma Presents Positive Data from a Pre-Specified Interim Analysis of the Phase II Clinical Program with Its Lead Product ATIR™
Kiadis Pharma B.V. announced positive interim data from the ongoing Phase II clinical study with its lead product ATIR™. ATIR™ is a cell-based product designed to enable stem cell transplantations from partially matched family donors for blood cancer patients who do not have a standard of care stem cell donor available.

Cyclacel Announces Enrollment of 486 Patients, DSMB Recommendations and that the Seamless Phase III Trial of Sapacitabine in AML Will Continue to Final Analysis
Cyclacel Pharmaceuticals, Inc. announced enrollment of 486 patients, continuation to final analysis and recommendations of the independent Data and Safety Monitoring Board (DSMB) of the company’s Phase III SEAMLESS study of oral sapacitabine capsules in acute myeloid leukemia.

Kite Pharma Announces Presentations Highlighting Cancer Immunotherapy T Cell Manufacturing Process
Kite Pharma, Inc. announced presentations on the company’s rapid, six-day manufacturing process for the production of Kite’s lead product candidate, KTE-C19. The manufacturing technology enables a patient’s T cells to be genetically modified using a gammaretroviral vector to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.

ARIAD Announces Phase II Dose-Ranging Trial of Iclusig (Ponatinib) to Begin by Mid-2015
ARIAD Pharmaceuticals, Inc. announced that it has concluded consultations with U.S. and European health authorities regarding the design of a randomized, dose-ranging trial to evaluate three starting doses of Iclusig® in patients with refractory, chronic-phase chronic myeloid leukemia.

BioLineRx Completes Dose Escalation Stage of Phase I Trial for Novel Stem Cell Mobilization Treatment
BioLineRx Ltd. announced that it has completed the dose escalation stage of a Phase I trial for its novel oncology platform, BL-8040, as a novel treatment for the mobilization of stem cells from the bone marrow to the peripheral blood circulation.

Bellicum Pharmaceuticals Announces Successful Dosing of First Patient Cohort with BPX-501 T Cells Following Haplo-Identical Hematopoietic Stem Cell Transplant
Bellicum Pharmaceuticals, Inc. announced that the first cohort of patients in the BP-004 trial has completed dosing with the Company’s genetically engineered donor T cells (BPX-501), after receiving a partial T depleted haplo-identical allogeneic hematopoietic stem cell transplant.

Celator® Pharmaceuticals Receives FDA Fast Track Designation for CPX-351 for the Treatment of Elderly Patients with Secondary Acute Myeloid Leukemia
Celator Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration granted Fast Track designation for CPX-351 for the treatment of elderly patients with secondary acute myeloid leukemia.

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