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News from the Field

Posted By Connections Editor, Monday, December 21, 2015
Phase IIa Results from CAR-T CD20 Immuno-Oncology Clinical Development Program for Advanced B-Cell Non-Hodgkin Lymphoma
Cellular Biomedicine Group Inc. announced results from an ongoing Phase IIa clinical trial evaluating the safety, feasibility and anti-tumor activity of its acquired chimeric antigen receptor-modified T-cells (CAR-T) immunotherapy (CBM-CD20.1) targeting CD20 for the treatment of patients with advanced B-cell non-Hodgkin lymphoma.

SELLAS Life Sciences Reports Promising Top-Line Phase II Data for WT1 Vaccine in Mesothelioma and Acute Myeloid Leukemia Patients
SELLAS Life Sciences Group announced top-line data from the company’s Phase II clinical study of its WT1 cancer vaccine in patients with malignant pleural mesothelioma.

Kiadis Pharma Announces Initiation of a Repeat-Dosing Phase II Clinical Trial with ATIR101™
Kiadis Pharma announced that it has obtained regulatory approvals from the national authorities both in Canada and in Belgium to start a further Phase II clinical trial with its lead product ATIR101™.

Seattle Genetics Announces Initiation of Phase I/II Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Opdivo® (Nivolumab) in Second-Line Hodgkin Lymphoma
Seattle Genetics, Inc. announced that it has initiated a Phase I/II clinical trial of ADCETRIS in combination with Opdivo for patients with relapsed or refractory Hodgkin lymphoma after failure of frontline treatment.

Bio-Path Holdings Announces Successful Completion of Cohort 7 of Phase Ib Clinical Trial Evaluating Liposomal Grb-2 in Acute Myeloid Leukemia
Bio-Path Holdings, Inc. announced the successful completion of Cohort 7 of its Phase Ib clinical trial evaluating the toxicity of its lead compound, liposomal Grb-2, combined with low-dose cytarabine chemotherapy in patients with advanced acute myeloid leukemia.

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News from the Field

Posted By Connections Editor, Friday, November 6, 2015
Updated: Thursday, November 5, 2015
Kite Pharma Provides Update on KTE-C19 Clinical Trial
Kite Pharma, Inc. provided an update from the company’s ongoing Phase I/II clinical trial of KTE-C19 in patients with refractory aggressive non-Hodgkin’s lymphoma who have failed prior chemotherapy treatments and have a poor prognosis. There was one patient death early in the study, which was determined to be unrelated to KTE-C19 by the study investigator.

Gamida Cell Achieves Major Regulatory Milestone: FDA and EMA Respond Positively to NiCord® Phase III Study Design Outline
Gamida Cell announced that the company has reached agreements with the FDA and EMA regarding the Phase III study design outline of NiCord. The company is moving forward now with plans to commence an international, multi-center, Phase III study of NiCord in 2016. . Phase I/II data of 15 patients are expected in Q4/2015.

Phase II Study of Venetoclax in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia with 17p Deletion Meets Primary Endpoint
AbbVie announced that a Phase II trial of its investigational medicine venetoclax met its primary endpoint of achieving overall response rates in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia with 17p deletion, according to an independent review analysis.

Kiadis Pharma Announces Full Enrollment of Its Phase II Clinical Study with Lead Product, ATIR101™
Kiadis Pharma N.V. announced full enrollment of patients into its ongoing Phase II clinical study with its lead product, ATIR101™. ATIR101™ 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 matching stem cell donor available.

Seattle Genetics Completes Enrollment in Phase III ALCANZA Clinical Trial Evaluating ADCETRIS® (Brentuximab Vedotin) in CD30-Expressing Cutaneous T-Cell Lymphoma (CTCL)
Seattle Genetics, Inc. announced that the company and its collaborator, Takeda Pharmaceutical Company Limited, completed patient enrollment in the Phase III ALCANZA clinical trial. ALCANZA is a randomized trial evaluating ADCETRIS versus investigator’s choice of methotrexate or bexarotene in 132 patients with CD30-expressing CTCL who received prior systemic therapy.

Avillion Announces Completion of Enrolment in Phase III BFORE Trial to Assess BOSULIF® (Bosutinib) as First-Line Treatment for Patients with Chronic Myelogenous Leukemia
Avillion LLP announced the completion of enrollment 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.

Amgen Receives CHMP Positive Opinions for Two New Treatment Options for Patients with Blood Cancer in Europe
Amgen announced that the Committee for Medicinal Products (CHMP) for Human Use of the European Medicines Agency adopted positive opinions recommending marketing authorization for Kyprolis®® (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma and BLINCYTO® (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukemia.

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Recent News from the Field

Posted By Connections Editor, Monday, August 31, 2015
Updated: Tuesday, August 25, 2015
Amphivena Therapeutics Presents Positive Data on Novel Acute Myeloid Leukemia (AML) Immunotherapy
Amphivena Therapeutics, Inc. announced positive data from several preclinical studies characterizing the company’s proprietary T-cell redirecting bispecific CD33/CD3-targeting antibodies as potential immunotherapeutics for the treatment of AML. Amphivena also announced selection of a development candidate, AMV--‐564, based on these compelling preclinical data.

Alnylam Reports Positive Initial Clinical Results for ALN-CC5, an Investigational RNAi Therapeutic Targeting Complement Component C5 for the Treatment of Complement-Mediated Diseases
Alnylam Pharmaceuticals, Inc. announced initial positive results from its ongoing Phase I/II clinical trial with ALN-CC5, an investigational RNAi therapeutic targeting complement component C5 for the treatment of complement-mediated diseases.

bluebird bio Reports New Beta-Thalassemia Major and Severe Sickle Cell Disease Data from HGB-205 Study at EHA
bluebird bio, Inc. announced long-term follow up of two patients with beta-thalassemia major and early safety and efficacy data in the first patient with severe sickle cell disease treated with LentiGlobin BB305 product candidate in the HGB-205 study.

Baxalta Reports Continued Progress on Phase I/II Clinical Trial of BAX335, Investigational Gene Therapy Treatment for Hemophilia B
Baxalta Incorporated reported continued progress on the Phase I/II open-label clinical trial assessing the safety and optimal dosing level of BAX 335, an investigational factor IX gene therapy treatment for hemophilia B.

Alnylam Reports New Positive Clinical Data for ALN-AT3, a Subcutaneously Administered, Investigational RNAi Therapeutic Targeting Antithrombin (AT) for the Treatment of Hemophilia and Rare Bleeding Disorders
Alnylam Pharmaceuticals, Inc. announced that new positive data from its ongoing Phase I clinical trial with ALN-AT3 – an investigational RNAi therapeutic for the treatment of hemophilia and rare bleeding disorders.

Amgen Announces Positive BLINCYTO® (Blinatumomab) Phase II Study Results in Patients with Relapsed/Refractory Philadelphia Chromosome-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
Amgen announced the top-line results of a Phase II open-label, single-arm, multicenter trial to evaluate the efficacy and safety of BLINCYTO® in adults with relapsed or refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia.

ERYTECH Announces Two Positive DSMB Reviews
ERYTECH Pharma announced positive safety reviews after the completion of the first cohort in the company’s US Phase I study with ERY-ASP in acute lymphoblastic leukemia, and following the treatment of the first three patients with ERY-ASP in combination with Folfox in its Phase II study in pancreatic cancer.

TG Therapeutics Announces the Triple Combination of TG-1101, TGR-1202 and Ibrutinib Is Safe and Highly Active in Patients with Advanced B-Cell Malignancies
TG Therapeutics, Inc. announced clinical results from its ongoing study with TG-1101 (ublituximab), the company’s novel glycoengineered anti-CD20 monoclonal antibody in combination with the company’s oral, once-daily, PI3K delta inhibitor, TGR-1202 and ibrutinib, a BTK inhibitor.

Chimerix Completes Targeted Enrollment for Brincidofovir Phase III SUPPRESS Trial
Chimerix, Inc. announced the successful enrollment of the targeted 450 patients in SUPPRESS, the Phase III trial evaluating brincidofovir for the prevention of clinically significant cytomegalovirus infection in hematopoietic cell transplant, also known as bone marrow or stem cell transplant recipients.

Celator® Pharmaceuticals Announces Positive Induction Response Results from Phase III Study of CPX-351 in Patients with High-Risk (Secondary) Acute Myeloid Leukemia
Celator Pharmaceuticals, Inc. announced final induction response rate results in the Phase III study comparing CPX-351 liposome injection to the standard of care regimen in patients with untreated high-risk (secondary) acute myeloid leukemia.

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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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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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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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News Roundup: December 2014

Posted By Connections Editor, Monday, January 5, 2015
Updated: Tuesday, December 30, 2014

bluebird bio Announces First Patient with Sickle Cell Disease Transplanted with LentiGlobin Gene Therapy

bluebird bio, Inc., a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and orphan diseases, announced that the first subject with severe sickle cell disease has undergone infusion with bluebird bio’s LentiGlobin BB305 drug product in an autologous hematopoietic stem cell transplantation.

AgonOx’s OX40 Platform Being Utilized in MedImmune’s Phase I OX40 Agonist Study

AgonOx, a biotechnology company focused on immunotherapy development, announced that its OX40 platform is being utilized in MedImmune’s Phase I trial of its humanized OX40 agonist, MEDI6383. 

Theravectys Provides Update On Its Phase I/Ii Lentiviral Vector-Based Therapeutic Vaccine Trial

THERAVECTYS reports promising preliminary results in the first-ever vaccination trial conducted with lentiviral vectors. The randomized, placebo-controlled trial currently enrolls 38 HIV-positive patients under highly active antiretroviral therapy in 12 clinical sites in France and Belgium and aims at comparing the safety, tolerability and immunogenicity of its therapeutic vaccine candidate at 3 different doses versus placebo.

Bergenbio Receives Orphan-Drug Designation From FDA For BGB324 In The Treatment Of Acute Myeloid Leukaemia

BerGenBio AS  announces that the US Food and Drug Administration has granted orphan-drug designation for BGB324 for treatment of acute myeloid leukaemia (AML). BerGenBio had announced earlier that the first patient has been dosed in its multi-centre Phase 1b trial of BGB324, a selective inhibitor of Axl, in patients with AML. The two part trial will primarily investigate the safety and tolerability of BGB324 when administered as a single agent and in combination with a standard-of-care drug (cytarabine).

Sunesis Announces Results from Pivotal Phase III VALOR Trial of Vosaroxin and Cytarabine in Patients with First Relapsed or Refractory Acute Myeloid Leukemia

Sunesis Pharmaceuticals, Inc. announced results from the pivotal Phase III VALOR trial, a randomized, double-blind, placebo-controlled trial of vosaroxin and cytarabine in patients with first relapsed or refractory acute myeloid leukemia.

IMBRUVICA® (ibrutinib) Now Approved in Europe for Treatment of Two Blood Cancers

Pharmacyclics, Inc. announced that the European Commission has granted marketing approval for IMBRUVICA® (ibrutinib) throughout the 28 member states of the European Union. 

BioLineRx Files Protocol Amendment to Phase II Study for AML Treatment based on Encouraging Efficacy and Strong Safety Profile

BioLineRx Ltd. announced that in light of encouraging pharmacodynamic and excellent safety data from the ongoing Phase II clinical trial of BL-8040 for the treatment of patients with relapsed or refractory acute myeloid leukemia, the Company has filed with the U.S. Food and Drug Administration an amendment to the study protocol to test additional cohorts at higher doses in the current dose-escalation stage of the trial. 

Cell Source's Megadose Drug Combination Receives Regulatory Approval in Italy to Commence Human Clinical Trials

Cell Source, Inc announced its Megadose Drug Combination has been cleared for human clinical trials in Italy. Cell Source's proprietary Megadose Drug Combination is expected to increase bone marrow transplantation success and survival.



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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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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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June News Roundup

Posted By Connections Editor, Wednesday, June 25, 2014

First volunteers to receive blood cultured from stem cells in 2016

Red blood cells cultured in a laboratory will be trialed in human volunteers for the first time within the next three years, as part of a long-term research program funded by the Wellcome Trust. The £5 million Strategic Award was granted to a consortium led by the Scottish National Blood Transfusion Service, and will follow on from previous research that proved that red blood cells could be generated from stem cells.

 

Alnylam Reports Initial Positive Top-Line Data from Phase I Clinical Trial with ALN-AT3, an RNAi Therapeutic Targeting Antithrombin (AT) in Development for the Treatment of Hemophilia and Rare Bleeding Disorders (RBD)

Alnylam Pharmaceuticals, Inc. announced positive top-line results from its ongoing Phase I trial of ALN-AT3, a subcutaneously administered RNAi therapeutic targeting AT in development for the treatment of hemophilia and RBD.

 

Umbilical Cord Stem Cell Therapy Clinical Trial for Multiple Sclerosis Gets Green Light

Translational Biosciences, a subsidiary of Medistem Panama, has received the green light for a phase I/II clinical trial using human umbilical cord-derived mesenchymal stem cells for multiple sclerosis from the Comité Nacional de Bioética de la Investigación Institutional Review Board .

 

Clinical Trial Investigates Cord Blood Stem Cells to Treat Cerebral Palsy in Children

Cord Blood Registry® announces the launch of an FDA-regulated clinical trial being conducted at The University of Texas Health Science Center at Houston to investigate two forms of stem cell therapy in children diagnosed with cerebral palsy. The randomized, placebo-controlled study aims to compare the safety and efficacy of an intravenous infusion of cord blood stem cells to bone marrow stem cells.

 

Emmaus Life Sciences Announces Positive Top-Line Results of Its Phase III Clinical Trial For Sickle Cell Disease

Emmaus Life Sciences, Inc. announced that preliminary top-line results of its Phase III clinical trial evaluating the safety and efficacy of its treatment for sickle cell anemia and sickle beta-0 thalassemia met both the primary and secondary endpoints of the clinical trial.

 


bluebird bio Announces First Patient Transplanted in Phase I/II Northstar Study for the Treatment of Beta-Thalassemia

Bluebird bio, Inc. announced that the first subject with beta-thalassemia major has been enrolled in its Phase I/II Northstar Study (HGB-204) in the United States and has undergone infusion with bluebird bio’s LentiGlobin drug product in an autologous hematopoietic stem cell transplantation.

 

Ambit Announces Initiation of Phase II Cohort in MD Anderson Sponsored Study of Quizartinib in AML and High Risk MDS

Ambit Biosciences announced the initiation of the Phase II cohort of the MD Anderson Cancer Center-sponsored Phase I/II study of quizartinib in combination with either 5-azacitidine or low dose cytarabine for previously untreated FLT3-ITD positive acute myeloid leukemia (AML) patients age 60 or older, or FLT3-ITD positive AML patients 18 years of age or older in first relapse.

 

Moffitt Cancer Center’s Phase III Study May Be Game-Changer for Acute Myeloid Leukemia

Moffitt Cancer Center researchers say clinical trials for a new experimental drug to treat acute myeloid leukemia are very promising. Patients treated with CPX-351, a combination of the chemotherapeutic drugs cytarabine and daunorubicin, are showing better responses than patients treated with the standard drug formulation.

 

PIXUVRI® Launched in UK for Adult Patients with Multiply Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

Cell Therapeutics, Inc. announced the launch of PIXUVRI® (pixantrone), the first new treatment for adult patients in the United Kingdom with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

GSK and Genmab Receive FDA Approval for Arzerra® (Ofatumumab) as First-Line Treatment in Combination with Chlorambucil for Patients with Chronic Lymphocytic Leukemia (CLL) for Whom Fludarabine-Based Therapy Is Considered Inappropriate

The FDA approval of the first-line indication is based on results from a Phase III study (COMPLEMENT 1) which demonstrated statistically significant improvement in median progression-free survival in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.

 

Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration  has granted the investigational PD-1 immune checkpoint inhibitor nivolumab Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab.

 

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