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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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April News Roundup

Posted By Connections Editor , Friday, May 2, 2014
Updated: Monday, April 28, 2014

EBiSC – the first European bank for induced pluripotent stem cells

Pharmaceutical companies who are members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) join forces with small and medium-sized enterprises and academia in an Innovative Medicines Initiative supported public private partnership project to establish the leading facility for the storage and distribution of induced pluripotent stem cells in Europe.


Fate Therapeutics Announces Observed Effects of Pharmacologic Modulation on T Cell Compartment From Its Phase 1b Study of PROHEMA(R)

Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced the release of new data on the observed effects of ex vivo pharmacologic modulation on CD8+ T cells and immune reconstitution from its previously-completed Phase 1b clinical trial of PROHEMA® (16, 16-dimethyl prostaglandin E2, or dmPGE2, modulated cord blood) in adult patients undergoing hematopoietic stem cell transplantation for hematologic malignancy (the ProHema-01 trial). 

Cerebral Palsy and the Potential of Cord Blood Stem Cells

Cord Blood Registry® (CBR®) is fueling innovation in newborn stem cell research. CBR is partnering with two preeminent institutions, the University of Texas Health Science Center at Houston and Georgia Regents University, to establish FDA-regulated clinical trials investigating whether an intravenous infusion of a child's own cord blood cells, banked at the time of their birth, will lessen the symptoms of cerebral palsy.


U.S. National Institutes of Health to Commence New Study of Pluristem’s PLX Cells for Acute Radiation Syndrome Treatment

Pluristem Therapeutics, Inc. a leading developer of placenta-based cell therapies, announced that the U.S. National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health, will commence a mechanism-of-action study of Pluristem’s PLacental eXpanded RAD cells for the treatment of acute radiation syndrome.

REGiMMUNE Begins Enrollment for Phase II Clinical Trial for Graft versus Host Disease

REGiMMUNE Corporation announced that it has begun a Phase II study of its proprietary compound RGI-2001 for GvHD associated with hematopoietic stem cell transplantation. The study was initiated following the successful completion of a Phase I study in patients with bone marrow or peripheral blood stem cell transplantation leukemia patients following chemotherapy.

TotipotentRX and ThermoGenesis Achieve Bone Marrow Stem Cell Transplant Milestone

ThermoGenesis Corp. a cellular therapy medical device company and TotipotentRX Corporation, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular and orthopedic disease announced the TotiPotentRX cellular therapy clinical team in partnership with Fortis Healthcare, Gurgaon (New Delhi) has achieved its 20th pediatric bone marrow transplant.


Gamida Cell’s StemEx® Achieves Primary Endpoint in Phase II/III Clinical Study 

Gamida Cell announced that its flagship product, StemEx, reached its primary endpoint of improving overall survival in a Phase II/III study which compared the use of StemEx as part of a transplantation regimen to historical controls in the treatment of patients with hematological malignancies such as leukemia and lymphoma.

SRI International Launches FASTcell Screening Services for Identification and Characterization of Rare Circulating Cancer Cells 

SRI International announced the availability of its FASTcell™ technology offered as a testing service for detecting and characterizing rare circulating tumor cells from whole blood samples. 

MEI Pharma Receives Orphan Status for Lead Drug Candidate Pracinostat for Treatment of Acute Myeloid Leukemia

MEI Pharma, Inc. announced that the U.S. Food and Drug Administration has granted orphan drug designation to the company’s investigational drug Pracinostat for the treatment of acute myeloid leukemia,


Igenica Enrolls First Patient in Phase I Trial of IGN523 to Treat Acute Myeloid Leukemia

Igenica Biotherapeutics announced that the first patient has been dosed in a Phase I clinical trial of IGN523 in patients with relapsed or refractory acute myeloid leukemia (AML). The trial is designed to assess the safety, pharmacokinetics and clinical activity of IGN523, an antibody targeting CD98, a cell surface protein frequently overexpressed on AML cells. 


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February News Roundup

Posted By Connections Editor , Friday, February 28, 2014
Updated: Tuesday, February 18, 2014

bluebird bio Announces First Patient Transplanted in Phase 1/2 HGB-205 Study for the Treatment of Beta-Thalassemia and Sickle Cell Anemia

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 beta-thalassemia major has been enrolled in its phase 1/2 HGB-205 study in France and has undergone infusion with bluebird bio’s LentiGlobin drug product in an autologous hematopoietic stem cell transplantation.

BioLineRx Announces Promising Initial Phase 2 Results of Acute Myeloid Leukemia Treatment

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today promising initial results for its BL-8040 drug candidate in a Phase 2 clinical trial for patients with relapsed or refractory acute myeloid leukemia.

Independent Data Monitoring Committee recommends Phase III study of IMBRUVICA™ (ibrutinib) versus ofatumumab be stopped early based on statistically significant improvement in progression free survival and overall survival

Pharmacyclics, Inc. announced that an Independent Data Monitoring Committee (IDMC) unanimously recommended that the Phase III RESONATE study, PCYC-1112-CA, a head-to-head comparison of IMBRUVICATM (ibrutinib) versus ofatumumab, be stopped early because the primary and a key secondary endpoint of the study have been met.

University of Utah doctor performs historic first procedure using new technique of retrograde gene therapy on a human heart

Ernie Lively became the first patient in the world to undergo retrograde gene therapy at University of Utah Hospital, a novel procedure designed to deliver stem cells to the heart to repair damaged muscle and arteries in the most minimally invasive way possible.

NASA, CASIS Make Space Station Accessible for Stem Cell Research

NASA and the Center for the Advancement of Science in Space (CASIS) are enabling research aboard the International Space Station that could lead to new stem cell-based therapies for medical conditions faced on Earth and in space. Scientists will take advantage of the space station's microgravity environment to study the properties of non-embryonic stem cells.

apceth’s Ground-Breaking First-In-Man, First-In-Class Clinical Trial in Oncology with Genetically Modified Mesenchymal Stromal Cells Is Now Enrolling

As a world first, apceth announced that the TREAT ME Phase I/II clinical trial for patients suffering from advanced adenocarcinoma of the gastro-intestinal tract has commenced. This is the first clinical trial world-wide with genetically-modified mesenchymal stromal cells.

New Report on Stem Cell Research Reveals the Field is Growing Twice as Fast as the World Average

Elsevier, EuroStemCell, and Kyoto University's Institute for Integrated Cell-Material Sciences, released "Stem CellResearch report: Trends and Perspectives on the Evolving International Landscape" at the World Stem Cell Summit. This new, comprehensive analysis of the growth and development of the stem cell field as a whole, closely examines the research landscape for embryonic stem cell, human embryonic stem cell and induced pluripotent stem cell.

Child with Cerebral Palsy Treated with Umbilical Cord Blood Derived Autologous Stem Cells

Cryo-Save Group N.V., the leading international stem cell storage company and the largest family stem cell bank in Europe, announced that on December 10th 2013 a 4-year-old girl in Spain received an infusion of stem cells derived from her own umbilical cord blood for the treatment of her cerebral palsy.



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December News Roundup

Posted By Connections Editor, Tuesday, December 31, 2013
Updated: Monday, December 23, 2013

OMP-54F28 (Fzd8-Fc) Program Reaches Dose Escalation Milestone in Phase 1a Clinical Trial; Triggers $15 Million Payment From Bayer Pharma AG

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells, or tumor-initiating cells, announced today that it has earned a $15 million milestone payment from Bayer Pharma AG related to achieving a dose escalation milestone in the Phase 1a clinical trial of OMP-54F28 (Fzd8-Fc). OMP-54F28 is an antagonist of the Wnt pathway, a key cancer stem cell pathway.

$100 Million Gift Launches Sanford Stem Cell Clinical Center
In a bold and singular step toward delivering the therapeutic promise of human stem cells, businessman and philanthropist T. Denny Sanford has committed $100 million to the creation of the Sanford Stem Cell Clinical Center at the University of California, San Diego.The Sanford Center will accelerate development of drugs and cell therapies inspired by and derived from current human stem cell research; establishing, promoting and disseminating clinical trials and patient therapies that will help more quickly transform promise into reality.

ViGene Biosciences Introduces World's Largest Collection of Pre-Made Human Full-Length cDNA ORF and miRNA Adenoviruses
ViGene Biosciences, Inc. announced the launch of its world's largest collection of premade human full-length cDNA ORF and miRNA adenoviruses. The collection features over 1,240 pre-packaged human miRNA precursor adenoviruses and 6,000 pre-packaged human full-length cDNA adenoviruses.

Actinium Pharmaceuticals Announces Plans for Iomab™-B Phase III Pivotal Trial Following Meeting with FDA
Actinium Pharmaceuticals, Inc. a biopharmaceutical company developing targeted payload immunotherapeutics for the treatment of advanced cancers, provided a corporate update on its two most advanced clinical programs. Kaushik J. Dave Ph.D., MBA, President and Chief Executive Officer discussed recent progress and outline development plans for the company's clinical stage products: Iomab™-B and Actimab™-A.

Americord Advances Method of Obtaining Mesenchymal Stem Cells from the Placenta
Americord, announced that it has validated a revised process for the preservation of mesenchymal stem cells (MSCs) from placenta tissue. The new method greatly improves the success rate for preserving viable MSCs from Placenta Tissue, a service first developed in 2012.

Polaris Group Announces Treatment of First Patient in Phase II Study of ADI-PEG 20 in Acute Myeloid Leukemia
Polaris Group announced that the first patient has been dosed in its Phase II trial of ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, for the treatment of Relapsed/Refractory Acute Myeloid Leukemia.

The Leukemia & Lymphoma Society Applauds FDA's Approval of Gazyva® as First-Line Treatment for Patients with Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration's (FDA's) approval of Gazyva® is an important advance for patients diagnosed with chronic lymphocytic leukemia (CLL). Gazyva, the first treatment approved through the FDA's breakthrough therapy designation, is indicated in combination with chlorambucil to treat previously untreated patients with CLL.

Kiadis Pharma Provides Positive Update on its Phase II Clinical Program with Blood Cancer Treatment ATIR™
Kiadis Pharma B.V. announced the successful Phase II enrollment of approximately ten patients of whom the majority have already been transplanted and received ATIR™.

New HHS Rule: Blood Stem Cells Aren't for Sale
The Department of Health and Human Services has issued a proposed rule that would include hematopoietic stem cells acquired by apheresis under the definition of "human organ," precluding payment for them.

ERYTECH Announces Positive DSMB Review of its Phase IIb Study in Acute Myeloid Leukemia
ERYTECH Pharma announced that an independent Data and Safety Monitoring Board (DSMB) completed its first assessment of the company’s Phase IIb study in Acute Myeloid Leukemia study and unanimously recommended continuation of the trial without modification

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News Roundup: October 2013

Posted By Connections Editor, Friday, November 1, 2013
Updated: Monday, October 28, 2013

OncoMed Pharmaceuticals Granted Patent for Methods of Treating Cancer With Its Novel Wnt Pathway Targeting Antibody Vantictumab (OMP-18R5)

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,507,442 to OncoMed for methods of treating cancer with its antibody vantictumab (OMP-18R5). Vantictumab targets and inhibits the Wnt pathway, which is believed to be an important CSC pathway. The patent expires in 2029.

Targeted Medical Pharma Initiates Clinical Trial of Red Blood Cell Stimulating Formulation

Targeted Medical Pharma, Inc., announced that the company has initiated a third open-label clinical trial of its oral amino acid-based erythropoietin stimulating system (ESS) to determine increased red blood cell production in subjects diagnosed with anemia of chronic disease.

First patient treated in groundbreaking stem cell therapy trial for heart attack

Canadian researchers have treated the first patient in a world-first clinical trial using genetically enhanced stem cells to repair damaged heart muscle after a major heart attack. The formal name of the trial is ENACT-AMI, which stands for "Enhanced Angiogenic Cell Therapy – Acute Myocardial Infarction.”

Adaptive Biotechnologies Receives $2.53 million Phase II SBIR to Develop Test to Identify Cancer Patients at Risk of Death by Infection after Cord Blood Transplants

Adaptive Biotechnologies announced that it received a $2.53 million Phase II Small Business Innovation Research award from the National Heart, Lung, and Blood Institute, a division of the NIH, to commercialize a test to measure the ability of a cancer patient’s adaptive immune system to fight infection after a cord blood transplant.

Celator®pharmaceuticals announces start of clinical study in patients with untreated myelodysplastic syndrome (MDS) or acute myeloid leukemia at high risk of treatment-related mortality

Celator Pharmaceuticals, Inc., a pharmaceutical company developing new and more effective therapies to treat cancer, announced that patients have been enrolled in an investigator-initiated clinical study evaluating CPX-351 (cytarabine:daunorubicin) Liposome Injection in patients with untreated high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), excluding acute promyelocytic leukemia, at high risk of treatment-related mortality.

Gamida Cell Announces the Successful Transplantation of the First Patient in The Company’s Phase I/II Study of NiCord® in a Single Cord Configuration

Gamida Cell announced that the first patient has been successfully transplanted in the company’s second Phase I/II study of NiCord®, as an alternative, experimental treatment for blood cancers. The transplant took place at Duke University Medical Center. Of great significance: This is the first study researching the outcome of a whole umbilical cord blood unit (UCBU) expanded in culture and transplanted in myeloablated patients without the support of un-manipulated stem cells derived from a second UCBU.

Volasertib* receives FDA Breakthrough Therapy designation for treatment of patients with acute myeloid leukaemia

Boehringer Ingelheim announced that the FDA has granted a Breakthrough Therapy designation to volasertib*, a selective and potent polo-like kinase (Plk) inhibitor, for the treatment of patients with AML.

Factor Bioscience Granted First U.S. Patent for RNABased Reprogramming Technology

The United States Patent and Trademark Office today granted Factor Bioscience the first patent covering methods for reprogramming cells using RNA, a technology with wideranging applications in biological research and personalized medicine. The patented methods can transform patient skin cells into stem cells more rapidly, efficiently, and safely than previous techniques.

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News Roundup: August 2013

Posted By Connections Editor, Monday, September 9, 2013
Updated: Thursday, August 22, 2013

Spanish scientists successfully generate 'artificial bones' from umbilical cord stem cells
Scientists in Granada, Spain, have patented a new biomaterial that facilitates generating bone tissue—artificial bones in other words—from umbilical cord stem cells . The material, consisting of an activated carbon cloth support for cells that differentiate giving rise to a product that can promote bone growth, has recently been presented at a press conference at the Biomedical Research Centre, Granada.

Stem Cell Agency’s Board Approves $70 Million Plan to Develop Innovative Alpha Clinics
A $70 million plan to create a new statewide network of sites that will act as a hub for stem cell clinical trials was approved by the governing Board of California’s stem cell agency, the California Institute for Regenerative Medicine (CIRM).

Scéil™: a new offering for the general public to turn adult cells into stem cells and store them
The Cellectis Group announced today that it is launching Scéil™, an offering for the general public that involves storing induced pluripotent stem cells (iPS) generated from a skin sample so that people can benefit, if needed, from future regenerative medicine treatments as soon as they become available.

BioLineRx Enrolls First Patient in Phase 2 Clinical Trial for BL-8040, for Treatment of Leukemia
BioLineRx, a biopharmaceutical development company, announced enrollment of the first patient in a Phase 2 trial for BL-8040, for the treatment of acute myeloid leukemia (AML).

New sickle cell anemia therapy advances to phase II clinical trials
Seeking to improve the lives of sickle cell anemia sufferers around the world, researchers from the La Jolla Institute for Allergy and Immunology, the Dana-Farber/Children's Hospital Cancer Center in Boston and the BloodCenter of Wisconsin in Milwaukee and others are preparing to launch Phase II of a clinical trial to investigate a potential new therapy for reducing the disorder’s severest symptoms.

FDA puts Cell Therapeutics blood cancer drug on hold after death
Cell Therapeutics Inc said the U.S. Food and Drug Administration has placed a partial clinical hold on the company's experimental blood cancer drug after the death of a patient.

MEI Pharma Initiates Phase II Clinical Trial of Pracinostat and Vidaza® in Frontline Myelodysplastic Syndrome
MEI Pharma, Inc. announced that the first patients have been dosed in a Phase II clinical trial of its lead drug candidate Pracinostat in combination with Vidaza (azacitidine) in patients with previously untreated intermediate-2 or high-risk myelodysplastic syndrome (MDS).

Market Access Granted in Italy for Aggressive non-Hodgkin Lymphoma Treatment, PIXUVRI® (pixantrone)
Cell Therapeutics, Inc. (CTI) announced that the Company has been granted market access by the Italian Medicines Agency (AIFA) for the medicinal product PIXUVRI® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressiveB-cell non-Hodgkin lymphoma (patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy).

FDA grants Roche’s obinutuzumab (GA101) Priority Review for previously untreated chronic lymphocytic leukemia (CLL)
Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for obinutuzumab (GA101) and granted Priority Review for GA101 in the treatment of chronic lymphocytic leukemia (CLL), one of the most common forms of blood cancer, based on final stage 1 data from the pivotal CLL11 trial.

Celgene Will Discontinue Phase III ORIGIN® Trial in Previously Untreated Elderly Patients with B-Cell Chronic Lymphocytic Leukemia
Celgene Corporation announced that after consultation with the U.S. Food and Drug Administration (FDA) Celgene will discontinue treatment with REVLIMID® (lenalidomide) in the open-label, phase III ORIGIN® trial, which enrolled 450 patients in over 100 sites in 26 countries.

Roche's obinutuzumab (GA101) delayed disease progression longer than MabThera/Rituxan in people with one of the most common forms of blood cancer
Roche announced positive results from the phase III CLL11 study. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint showing that GA101 plus chlorambucil helped people live significantly longer without their disease worsening (progression-free survival; PFS) compared to MabThera/Rituxan plus chlorambucil.

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News Roundup: June 2013

Posted By Connections Editor, Sunday, June 30, 2013
Updated: Friday, June 28, 2013

Gamida Cell Reports StemEx® Phase II/III Study Safety and Efficacy Data
Gamida Cell announced additional analyses for the Phase II/III, multi-center, multi-national, historical cohort-controlled study to evaluate efficacy and safety of StemEx® as an alternative transplantation treatment for patients with high risk leukemia and lymphoma. Twenty-five bone marrow transplant centers worldwide treating 101 patients with hematologic malignancies following myeloablative therapy who could not find a family related matched bone marrow donor participated in the study.

U of M Researchers Conduct World’s First Cord Blood Transplant Aimed at Curing Leukemia and HIV/AIDS
University of Minnesota physicians will perform the world’s first cord blood transplant designed specifically to cure a pediatric patient of HIV/AIDS and acute lymphoblastic leukemia .The procedure will take place at the University of Minnesota Amplatz Children's Hospital and will be completed by a clinical team composed of transplant physicians Michael Verneris, M.D., John Wagner, M.D., and HIV/AIDS infectious disease specialist Timothy Schacker, M.D.

Pharmacyclics Completes Enrollment of First Phase III Ibrutinib CLL Study - RESONATE™ and Announces Completion of Enrollment of Phase II Ibrutinib MCL Study - SPARK
Pharmacyclics, Inc. announced that the enrollment target of 350 patients for its Phase III study using ibrutinib monotherapy versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), (RESONATE™) was achieved on April 3, 2013. An additional 41 patients were screened and are allowed to participate in this study which has now been officially closed to enrollment.

Stem Cells Boom in Vet Clinics
New guidance from the US Food and Drug Administration (FDA) could soon rein in veterinary uses of stem cells, a practice that has exploded in the United States over the past decade, even though most therapies are unproven. Many researchers and veterinarians say that the guidance, a draft of which the agency plans to issue by the end of the year, is overdue. But others worry that FDA interference could hamper research that could benefit animals — and their human companions.

Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis
Sanofi announced that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR302503 for myelofibrosis, met its primary endpoint in both dose groups. The primary endpoint assessed the proportion of patients achieving >35% reduction of spleen volume.

Lilly Announces Enzastaurin Phase III Study Did Not Meet Primary Endpoint in Diffuse Large B-Cell Lymphoma
Eli Lilly and Company announced Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. There were no new safety findings, and the safety data were consistent with previously disclosed studies.

More Than 240 Innovative Medicines in Development for Leukemia, Lymphoma and Other Blood Cancers
America’s biopharmaceutical research companies are developing 241 medicines for blood cancers- leukemia, lymphoma and multiple myeloma, according to a new report and overview released by the Pharmaceutical Research and Manufacturers of America.

SymBio Initiates Japanese Phase II Trial for TREAKISYM® (Bendamustine) in CLL
SymBio Pharmaceuticals Limited announced that it commenced enrollment in a Phase II clinical trial in Japan for bendamustine hydrochloride (TREAKISYM®) in chronic lymphocytic leukemia patients.

Onconova Completes Enrollment in ONTIME Pivotal Phase III Study of Rigosertib in Patients with High-Risk Myelodysplastic Syndromes
Onconova Therapeutics, Inc. announced it has reached its enrollment goal of 270 for its pivotal Phase 3 ONTIME trial of rigosertib in patients with myelodysplastic syndromes who have failed prior therapy with hypomethylating agents.

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News Roundup: April 2013

Posted By Connections Editor, Wednesday, April 24, 2013
Updated: Wednesday, April 24, 2013

Stem Cell Agency Banks on $32 Million New Approach to Advance Research
When you need money you go to the bank. But when researchers need high quality stem cells where do they go to get those? Soon they’ll be able to go to a stem cell bank set up by California’s stem cell agency, the California Institute for Regenerative Medicine. The governing Board of the agency voted to approve nine applications to create the cells that will go in that bank and to run it.

Quest for Cures: The Leukemia & Lymphoma Society Seeks to Fund Three Critical Areas of Blood Cancer Research
Medical innovation and sustained research investment are dramatically transforming the landscape in blood cancers. To that end, The Leukemia & Lymphoma Society (LLS) continues to drive a progressive research agenda to improve outcomes for patients who urgently need new therapies. LLS announced it has identified three priority areas toward which it will direct new funding.

Pfizer’s BOSULIF® (bosutinib) Receives Conditional Marketing Authorization from the European Commission
Pfizer Inc. announced that the European Commission has granted conditional marketing authorization for BOSULIF® in the European Union for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

FRC's Dr. David Prentice Congratulates Kansas Senate for Passing Ethical Stem Cell Therapy Bill
Family Research Council Senior Fellow Dr. David Prentice congratulated the Kansas state senate for passing S.B. 199, a bill that would establish the Midwest Stem Cell Therapy Center, a regional hub to advance and deliver adult and cord blood stem cell therapies to patients and serving as a resource for adult and cord blood stem cells for therapies. The Center would also inform professionals and the public about such therapies. 

U.K. Agency Cautiously Endorses Mitochondria Replacement
There is broad public support in the United Kingdom for allowing a new type of IVF treatment that could prevent mitochondrial diseases, the country's Human Fertilization and Embryology Authority announced. The techniques would introduce new DNA into an embryo, and so it has raised thorny ethical questions. At the same time, the authority advised the government that several safeguards should be included in any proposals for new regulations that would permit clinics to perform the technique.

Stem-Cell Ruling Riles Researchers
Clinics that offer unproven stem-cell treatments often end up playing cat and mouse with health regulators, no matter which country they operate in. In Italy, however, one such treatment now has official sanction. The country’s health minister, Renato Balduzzi, has decreed that a controversial stem-cell treatment can continue in 32 terminally ill patients, mostly children — even though the stem cells involved are not manufactured according to Italy’s legal safety standards.

Retina Institute Japan and Dainippon Sumitomo Pharma Form a Capital Alliance towards the Development of Nobel Prize Winning iPS Cell Technology
Retina Institute Japan K.K. (RIJ) and Dainippon Sumitomo Pharma Co., Ltd. (DSP) announced that the two companies signed an agreement that DSP invests into RIJ to discuss alliance to put iPS cell technology to practical use.

Cord Blood Registry Is Advancing Regenerative Medicine Research at Exciting Pace
Cord Blood Registry® (CBR®) is fueling innovation in newborn stem cell research. As CBR prepares to release its 250th cord blood unit for medical use, the newborn stem cell bank announces that 71% of all its units released for use have been for emerging applications in regenerative medicine, such as brain injury, autism and type 1 diabetes. The other 29% have been for traditional transplant use, such as leukemia and sickle cell disease.

Minerva Biotechnologies Announces Major Breakthrough in Human Stem Cell Research
Minerva Biotechnologies, a leading cancer and stem cell development company announced a major breakthrough in human stem cell research. Minerva scientists converted established human stem cells to the elusive "naïve” state and maintained them there indefinitely simply by culturing the cells in the dimeric form of a natural, but newly discovered human growth factor, called NM23-H1. It is widely believed that figuring out how to stably induce naïve pluripotency in human stem cells is critical for realizing the promise of human stem cell therapies.

Promising Stem Cell Therapy for Leukemia Patients
Leukemia patients receive a bone marrow transplant, which allows them to build a "new” immune system. However, this immune system not only attacks cancer cells but healthy tissue too. Special antibodies will be used to protect healthy tissue in future.

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News Roundup: February 2013

Posted By Connections Editor, Wednesday, March 6, 2013
Updated: Tuesday, February 26, 2013

News from the field. A collection of industry, policy, government and other hot news from the field of hematology and stem cell.

Japan Stimulus to Boost Science
Japan's government approved a plan to spend $116 billion to jump-start the economy and set the stage for long-term growth. Sources in the Japanese press are hinting that research on renewable energy and on stem cells could land a significant chunk of the new cash.

U.S.-Based Gene Therapy Study Begins Treating Participants
Cooley's Anemia Foundation has learned that the first U.S.-based clinical trial in gene therapy for beta-thalassemia has begun treating trial participants. The Phase 1 study, the official title of which is "ß-Thalassemia Major With Autologous CD34+ Hematopoietic Progenitor Cells Transduced With TNS9.3.55 a Lentiviral Vector Encoding the Normal Human ß-Globin Gene,” is being conducted at Memorial Sloan-Kettering Cancer Center in Manhattan. The trial received FDA approval in the summer of 2012 and began recruiting study subjects soon thereafter.

Stem Cell Lawsuit Finally Over
The Supreme Court rejected a request to ban U.S.-funded research on human embryonic stem cells (hESCs). The decision brings to an end a long legal battle that has cast a shadow over hESC studies for over three years.


Genea Stem Cells (GSC): 25 New Disease Specific Pluripotent Stem Cell Lines Placed on the NIH Registry
Genea Stem Cells Pty Ltd (GSC), a supplier and developer of disease-specific human stem cells, announced that 25 of its disease specific embryonic pluripotent stem cell lines have been placed on the USA National Institutes of Health (NIH) human stem cell registry. These embryonic stem cell lines are now all available commercially for use in medical research.


First Gene Therapy Trial Launched for Fabry Disease
Researchers in Calgary, Alberta have launched the first gene therapy clinical trial in the world for Fabry disease that could ultimately lead to a permanent cure. Researchers will first remove a quantity of stem cells from a Fabry patient’s blood. Then a working copy of a new GLA gene will be inserted into the stem cells using a specially engineered virus. During the final phase of the trial, researchers hope to transplant these stem cells back into the donor patient and the new, working copy of the gene will make the missing enzyme.  

One millionth blood stem cell transplant marks major medical milestone

The Worldwide Network for Blood and Marrow Transplantation reported that he collaborative work of medical scientists and physicians across the globe has resulted in a major medical milestone: the world’s 1 millionth blood stem cell transplant, a procedure that has become a proven and essential therapy for many patients battling blood cancers like leukemia and lymphoma, as well as other critical diseases.  


Cell Therapeutics Begins Enrolment in Phase III PERSIST-1 Trial of Pacritinib for the Treatment of Myelofibrosis
Cell Therapeutics, Inc. (CTI) announced that the Company has initiated clinical trial sites and began enrolling patients in a Phase 3 clinical trial, known as PERSIST-1 or PAC325, for pacritinib, CTI's investigational JAK2 inhibitor, which is being evaluated for the treatment of patients with myelofibrosis

Seattle Genetics and Millennium Initiate Global Phase III Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Front-line CD30-Expressing Mature T-Cell Lymphoma (MTCL)
Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company announced the initiation of a global phase III clinical trial evaluating ADCETRIS in combination with chemotherapy for the treatment of newly diagnosed CD30-positive MTCL patients, including patients with systemic anaplastic large cell lymphoma and other types of peripheral T-cell lymphomas.

Cellular Dynamics Announces the Production of Human iPSC Lines Under cGMP Conditions
Cellular Dynamics International, Inc., a leading commercial producer of human induced pluripotent stem cell (iPSC) lines and tissue cells for drug discovery and safety, announced that it is producing human iPSC master cell banks from five individual donors under current Good Manufacturing Practices (cGMPs). Manufacturing human iPSCs and ultimately human cells under cGMPs enables the possible use of iPSC-derived human cells within a clinical setting.  

Gamida Cell’s StemEx® Achieves Primary Endpoint in Phase II/III Clinical Study

Gamida Cell announced today that its flagship product, StemEx, reached its primary endpoint of improving overall survival in a Phase II/III study which compared the use of StemEx as part of a transplantation regimen to historical controls in the treatment of patients with hematological malignancies such as leukemia and lymphoma.

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