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Industry News: June 2015

Posted By Connections Editor, Wednesday, July 1, 2015
Updated: Monday, June 29, 2015
BioLineRx Reports Successful Top-Line Safety and Efficacy Results for Novel Stem Cell Mobilization Treatment
BioLineRx Ltd. announced successful top-line results from the Phase I safety and efficacy study of its lead clinical candidate, BL-8040, as a novel approach for mobilization and collection of bone-marrow stem cells from the peripheral blood circulation.

Cardio3 BioSciences Enrolls First Patient in Phase I Trial for NKG2D CAR T-Cell
Cardio3 BioSciences announced the enrollment of the first patient in a Phase I clinical trial evaluating the Company’s lead CAR T-Cell therapy, NKG2D CAR T-Cell, in blood cancer patients with acute myeloid leukemia or multiple myeloma.

Targazyme, Inc. and M.D. Anderson Cancer Center Receive FDA IND Clearance for Phase I/II Study of TZ101-Treated Regulatory T Cells to Prevent Graft vs. Host Disease in Patients Eligible for Hematologic Stem Cell Transplantation
Targazyme Inc. announced that the U.S. Food and Drug Administration has granted IND Clearance to M.D. Anderson Cancer Center to start enrolling patients in a Phase I/II clinical study to evaluate the safety and efficacy of TZ101-fucosylated regulatory T cells in preventing and reducing the severity and incidence of graft vs. host disease in patients eligible for hematologic stem cell transplant.

Actinium Doses the First Patient in the Fourth, Final Cohort of Its Actimab-A Trial
Actinium Pharmaceuticals, Inc. announced that the first patient was successfully treated with Actimab-A drug candidate in the fourth and last cohort of the ongoing Phase I/II trial of Actimab-A. Actimab-A is being developed for newly diagnosed AML patients over the age of 60 ineligible for standard induction chemotherapy.

Genmab Announces Phase III Study of Arzerra® Met Primary Endpoint of Improved Progression-Free Survival in Patients with Relapsed CLL
Genmab A/S announced that the top-line results from the Phase III COMPLEMENT 2 study showed that treatment with Arzerra® (ofatumumab) plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival in patients with relapsed chronic lymphocytic leukemia (CLL) compared to those given fludarabine and cyclophosphamide alone.

Juno’s CAR-T Contender Comes through in Another Phase I Leukemia Study
Juno Therapeutics, Inc. announced encouraging clinical responses in a Phase I study evaluating JCAR017 in pediatric patients with relapsed/refractory acute lymphoblastic leukemia.

BioLineRx Initiates Expansion Stage of Phase II Clinical Trial for Novel Treatment for Acute Myeloid Leukemia
BioLineRx Ltd. announced successful completion of the dose escalation stage of its ongoing Phase II study of BL-8040, and commencement of the expansion stage at the optimal dose of this novel treatment for acute myeloid leukemia.

Generon Received US FDA Clearance to Initiate Phase IIa Study with F-652, a First-in-Class Biologic, to Treat Patients with Acute GvHD
Generon Corporation announced that it received US FDA clearance of the IND for a Phase IIa study, entitled “Recombinant Human Interleukin-22-IgG2-Fc (F-652) in Combination with Systemic Corticosteroids for the Treatment of Newly Diagnosed Grade II-IV Lower Gastrointestinal Acute Graft-versus-Host Disease in Hematopoietic Stem Cell Transplanta

GlycoMimetics Initiates Phase I/II Clinical Trial of GMI-1271 as Potential Treatment for Acute Myeloid Leukemia in Combination with Chemotherapy
GlycoMimetics, Inc. announced that the first patient has been dosed in a Phase I/II clinical study designed to evaluate the safety, pharmacokinetics and efficacy of GMI-1271, a novel and proprietary E-selectin antagonist in the company’s pipeline, when used in combination with chemotherapy in patients with acute myeloid leukemia.

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