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August/September News Roundup

Posted By Connections Editor, Friday, September 5, 2014
Updated: Wednesday, September 3, 2014

Bone Therapeutics Starts Patient Treatment in First Ever Clinical Trial with Allogeneic Bone Cell Therapy Product

Bone Therapeutics announced that the first patient has been treated with its novel allogeneic osteoblastic (bone-forming) cell therapy product ALLOB® in its Phase I/IIa study for the treatment of delayed union fractures.


Amgen Receives FDA Breakthrough Therapy Designation for Investigational BiTE® Antibody Blinatumomab in Acute Lymphoblastic Leukemia

Amgen announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to investigational bispecific T cell engager (BiTE®) antibody blinatumomab, for adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia, a rapidly progressing cancer of the blood and bone marrow.


MacroGenics Initiates Phase I Study of MGD006 for the Treatment of Acute Myeloid Leukemia

MacroGenics, Inc. announced that a first patient received drug in a Phase I study of MGD006 in relapsed or refractory acute myeloid leukemia. MGD006 is a humanized, Dual-Affinity Re-Targeting (DART®) bi-specific antibody-based molecule that binds to both CD123 and CD3, antigens expressed on leukemic cells and T lymphocytes, respectively.. This study marks the first clinical trial of a DART product candidate.


University of Pennsylvania’s Personalized Cellular Therapy for Leukemia Receives FDA’s Breakthrough Therapy Designation

A University of Pennsylvania-developed personalized immunotherapy has been awarded the U.S. Food and Drug Administration’s Breakthrough Therapy designation for the treatment of relapsed and refractory adult and pediatric acute lymphoblastic leukemia. The investigational therapy, known as CTL019, is the first personalized cellular therapy for the treatment of cancer to receive this classification.


Merck Initiates Phase III Study of Letermovir, an Investigational Antiviral for Prevention of Cytomegalovirus (CMV) Infection in High-Risk Bone Marrow Transplant Patients

Merck announced that the first patient has been enrolled in a global Phase 3 clinical study of letermovir (MK-8228), an investigational antiviral agent. The multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of letermovir for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants.


Innate Pharma SA Announces Completion of Target Enrollment in the Phase II EffiKIR Trial

Innate Pharma SA announced completion of target enrollment in the EffiKIR trial with 150 patients randomized. EffiKIR is a double-blind placebo-controlled randomized Phase II trial of lirilumab as maintenance treatment in elderly patients with acute myeloid leukemia in first complete remission.

MEI Pharma Reports High Response Rates in Phase II Study of Pracinostat in Front Line Acute Myeloid Leukemia

MEI Pharma, Inc. announced preliminary response data from the first stage of a two-stage, open-label Phase II clinical study of its investigational drug candidate Pracinostat in combination with Vidaza® in elderly patients with newly diagnosed acute myeloid leukemia who are unsuitable for intensive chemotherapy.


Synta Announces Advancement of Ganetespib into Phase III Extension of AML LI-1 Study for Patients with AML and High-Risk MDS

Synta Pharmaceuticals Corp. announced the advancement of ganetespib into the Phase 3 extension of the AML LI-1 (less intensive) trial. AML LI-1 is a multicenter, randomized Phase 2/3 clinical study evaluating several novel treatment regimens, including the combination of ganetespib with low dose cytarabine, in newly diagnosed elderly patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who are not eligible for intensive chemotherapy.

ERYTECH announces enrollment of first patient in Phase I/II study of ERY-ASP in Acute Lymphoblastic Leukemia in the United States

ERYTECH, a biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs,
announced the enrollment of the first patient in its Phase I/II study with ERY-ASP in Acute Lymphoblastic Leukemia in the United States of America.


GlycoMimetics Initiates First Clinical Trial of GMI-1271 as Potential Treatment for Blood-Related Cancers

GlycoMimetics, Inc. announced that the first healthy volunteer has been dosed in a Phase 1 clinical study designed to evaluate the safety, tolerability and pharmacokinetics of GMI-1271. GlycoMimetics is initially exploring the clinical use of the drug candidate to treat acute myeloid leukemia following preclinical studies of GMI-1271 for blood cancers and other cancers that are associated with elevated risk of metastasis and thrombosis.


U.S. Food and Drug Administration Approves Gilead’s Zydelig® (Idelalisib) for Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration has approved Zydelig® (idelalisib) 150 mg tablets for the treatment of three B-cell blood cancers.


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