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News Roundup: October - November 2014

Posted By Connections Editor , Thursday, October 30, 2014
Updated: Tuesday, October 28, 2014

Alnylam Receives Orphan Drug Designations in the European Union for ALN-AT3, an RNAi Therapeutic in Development for the Treatment of Hemophilia

Alnylam Pharmaceuticals, Inc. announced that the European Medicines Agency Committee for Orphan Medicinal Products has granted Orphan Drug Designations for ALN-AT3 as an orphan medicinal product for the treatment of hemophilia A and hemophilia B. Alnylam is developing ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin, for the treatment of hemophilia and other Rare Bleeding Disorders.


CEL-SCI Corporation Moves Ahead with Phase III Immunotherapy Head and Neck Cancer Trial

CEL-SCI Corporation announced its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection) has added Centre Hospitalier Universitaire de Québec’s L’Hotel Dieu de Quebec to its growing number of clinical sites in North America.


Avillion Announces Dosing of First Patients in Phase III BFORE Trial to Assess BOSULIF® (Bosutinib) as First-Line Treatment for Patients with Chronic Myelogenous Leukemia

Avillion LLP announced that the first patients have been dosed in the United States in a global Phase III clinical trial called “BFORE,” which is designed to assess the effectiveness and safety of BOSULIF® (bosutinib) as a first-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia.

AFL Approves Use of Regeneus’ Stem Cell Therapy, HiQCell for Injured Players

Regeneus Ltd. announced that the Australian Football League (AFL) has granted case-by-case approval for the use of its innovative stem cell therapy, HiQCell® as a treatment option for injured AFL players, typically including impact related osteoarthritis and tendonitis.

Celldex Therapeutics Initiates Pilot Study of CDX-301 in Allogeneic Hematopoietic Stem Cell Transplantation

Celldex Therapeutics, Inc. announced the initiation of a pilot study of CDX-301 for the mobilization and transplantation of allogeneic hematopoietic stem cells in patients with hematological malignancies undergoing hematopoietic stem cell transplantation.

GSK and Genmab Announce Positive Interim Result for Phase III Study of Ofatumumab as Maintenance Therapy for Relapsed CLL

GlaxoSmithKline plc and Genmab A/S announced that an Independent Data Monitoring Committee interim analysis of a Phase III study, PROLONG, reached the predefined significance level for efficacy (p≤0.001). The interim analysis demonstrated that treatment with ofatumumab (Arzerra™) met the primary endpoint of improving progression free survival. The study evaluated ofatumumab maintenance therapy versus no further treatment (observation) in patients with relapsed chronic lymphocytic leukemia (CLL) who responded to treatment at relapse.

Boston Strategics Corporation Initiates a Phase I Clinical Trial of the Anti-Cancer Agent “FF-10501″ for FUJIFILM in Patients with Advanced Hematologic Malignancies

Boston Strategics Corporation, a primary global strategic drug development provider for FUJIFILM Pharmaceuticals U.S.A., Inc., has begun a Phase I clinical trial of FUJIFILM’s anti-cancer agent FF-10501 in the United States in patients with advanced hematologic malignancies such as relapsed or refractory high-risk myelodysplastic syndromes.

Novel Drug Targeting Leukemia Cells Enters Clinical Trial

Researchers have launched a Phase I human clinical trial to assess the safety and efficacy of a new monoclonal antibody for patients with chronic lymphocytic leukemia, the most common form of blood cancer in adults.

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