Gamida Cell Reports StemEx® Phase II/III Study Safety and
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
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.
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.
Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2
Inhibitor in Myelofibrosis
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.
Enzastaurin Phase III Study Did Not Meet Primary Endpoint in Diffuse Large
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
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.
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
Onconova Completes Enrollment
in ONTIME Pivotal Phase III Study of Rigosertib in Patients with High-Risk
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.