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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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