Category Archives: FDA Stem Cell Trials

DALLAS, Dec. 17, 2012 (GLOBE NEWSWIRE) -- Resuscitation, cell regeneration, a new high blood pressure treatment and developments in devices for treating stroke are among the key scientific findings that make up this year's top cardiovascular and stroke research identified by the American Heart Association and American Stroke Association. "At this time of year, it's gratifying to reflect on scientific progress in the prevention and treatment of cardiovascular diseases and stroke," said Donna Arnett, Ph.D., president of the American Heart Association. "Cardiovascular disease research is truly helping people lead longer, healthier lives and the American Heart Association is pleased to be at the forefront of supporting, promoting and translating many important discoveries into practice." The association has been compiling an annual list of the top 10 major advances in heart disease and stroke research since 1996. The association's top research advances for 2012 include: 1. Extended CPR saves lives The effect of the duration of CPR on meaningful recovery is uncertain. A study of hospitals using the Get With The Guidelines-Resuscitation quality improvement program found survival was higher for cardiac arrest patients who received CPR for a longer amount of time. Patients at hospitals with the longest median duration of … Continue reading →

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced promising clinical data from investigator-sponsored studies of ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use, FOLOTYN (pralatrexate injection), and belinostat, Spectrums novel histone deacetylase (HDAC) inhibitor. As reported in poster presentations at the recent 54th Annual Meeting of the American Society of Hematology (ASH), studies of ZEVALIN showed promising results in diverse settings and potential indications, including first-line consolidation in patients with diffuse large B-cell lymphoma (DLBCL); treatment of elderly patients with non-Hodgkins lymphoma (NHL), and new drug combinations to treat follicular non-Hodgkins lymphoma (fNHL). In addition, preclinical in vivo research showed promising synergistic, anti-tumor activity of FOLOTYN, while a Phase 1 study demonstrated early evidence of activity of belinostat in combination therapy of patients, including those with relapsed or refractory acute leukemia. This years ASH meeting was another important conference for Spectrum, both because of the number of presentations 12 for ZEVALIN, 3 for FOLOTYN and 4 for belinostat and the high quality of the data, said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. Members of … Continue reading →

VILLA GUARDIA (COMO), Italy, Dec. 13, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (GENT) (the "Company") today announced that additional data from ongoing trials of Defibrotide were presented this week at the 54th Annual Meeting and Exposition of the American Society of Hematology (ASH) held at the Georgia World Congress Center in Atlanta, Georgia. Dr. Paul Richardson, Clinical Director of the Dana-Farber Cancer Institute, Boston, MA (USA), reported in an oral presentation the updated results of a large prospective study on the use of Defibrotide in the treatment of Hepatic Veno-Occlusive Disease (VOD) in hematopoietic stem cell transplant patients, from the ongoing Treatment IND Expanded Access Protocol (abstract #738). The interim analysis was based on 333 patients with severe veno-occlusive disease (sVOD) and multi-organ failure (MOF), enrolled between December 2007 and September 2011 at 68 centers across the United States. 305 patients had undergone hematopoietic stem cell transplant (HSCT) and of those patients, 30% of patients achieved a complete response (CR) and 50% survived to day 100 (D+100). Additional findings were as follows: Dr. Richardson also presented a poster outlining the results from the treatment of chemotherapy-induced VOD in non-stem cell transplant (non-SCT) patients enrolled in the Treatment IND Expanded Access … Continue reading →

ATLANTA--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today summarized ADCETRIS (brentuximab vedotin) data in relapsed Hodgkin lymphoma (HL) and other CD30-positive malignancies from multiple presentations at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. Highlights include compelling survival data from long-term follow up in a pivotal clinical trial of ADCETRIS in relapsed or refractory HL and a retrospective comparison of overall survival among patients treated with ADCETRIS to those not treated with ADCETRIS following an autologous stem cell transplant (ASCT). In addition, data describe the activity and tolerability of ADCETRIS in the salvage HL setting from an investigator-sponsored trial and in relapsed patients age 60 or over with CD30-positive malignancies, including HL. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. "There are more than a dozen data presentations at ASH evaluating the use of ADCETRIS in CD30-positive malignancies and we are very encouraged by both the broad application across multiple hematologic disease areas as well as the encouraging activity associated with ADCETRIS, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The extensive investigator and corporate data presentations at … Continue reading →

ATLANTA--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today announced results from a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed advanced stage Hodgkin lymphoma (HL) patients. The data were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS is currently not approved for use in the front-line treatment of HL. In the phase I trial, newly diagnosed patients received ADCETRIS concomitantly with either ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) or AVD, which removes bleomycin from the regimen. At the end of front-line therapy, 24 of 25 patients (96 percent) treated with ADCETRIS plus AVD and 21 of 22 (95 percent) patients treated with ADCETRIS plus ABVD had a complete remission. None of the patients treated in the ADCETRIS plus AVD cohort experienced pulmonary toxicity, compared with an expected rate of pulmonary toxicity caused by ABVD alone of 10-25 percent. The trial was designed to establish the safety profile and maximum tolerated dose when adding ADCETRIS to ABVD or AVD. Antitumor activity was assessed … Continue reading →

NEEDHAM, Mass.--(BUSINESS WIRE)-- Celldex Therapeutics, Inc. (CLDX) announced positive results from a Phase 1 multi-dose study of CDX-301 (FMS-like tyrosine kinase-3 ligand) demonstrating that CDX-301 was well-tolerated and can safely and effectively mobilize hematopoietic cell populations in healthy volunteers. The data support future development of CDX-301 in a number of indications, including hematopoietic stem cell transplant and cancer immunotherapy. Results were presented in a poster entitled A Phase 1 Trial of the Hematopoietic Growth Factor CDX-301 (rhuFlt3L) in Healthy Volunteers on Monday, December 10, 2012 at 6:00 pm ET at the American Society of Hematology 54th Annual Meeting and Exposition. The lead author was Niroshana Anandasabapathy, MD, PhD, Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY. The data presented today confirm previous studies and support continued development of CDX-301, both alone and in combination with other Celldex assets across a broad range of indications, said Thomas Davis, MD, Senior Vice President and Chief Medical Officer. In particular, we believe CDX-301 holds significant potential for use in hematopoietic stem cell transplant, where it has demonstrated improvement of blood cell reconstitution in preclinical in vivo models. Data from the Phase 1 study will enable us to define an … Continue reading →

NEW YORK & PETACH TIKVA, Israel--(BUSINESS WIRE)-- BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, is proud to announce that its positive Phase I/II ALS clinical trial data was selected as the opening presentation of the prestigious Israel Neurological Associations Annual Meeting, which will convene on December 12, 2012 in Jerusalem, Israel. The data, regarding the first 12 ALS patients in the trial, will be presented by Principal Investigator Dr. Dimitrios Karussis, MD, of the Neurology Department at Hadassah Medical Center in Jerusalem, Israel. The trial, which was designed to evaluate the safety and tolerability of BrainStorm's proprietary NurOwn cell therapy (bone marrow-derived, autologous, differentiated mesenchymal stromal cells) is being conducted at the Hadassah Medical Center in Jerusalem, Israel. The data being presented is on the first group of patients, all of whom suffer from early stage or progressive ALS, also known as Lou Gehrig's disease. All patients enrolled were transplanted with NurOwn either intramuscularly or intrathecally. NurOwn was granted Orphan Drug designation for ALS by the US Food and Drug Administration (FDA). BrainStorm is planning to expand its ALS clinical development to the United States in 2013, pending FDA approval. The Company … Continue reading →

ATLANTA--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today announced that results from two ongoing investigator-sponsored phase II clinical trials of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS has not been approved for use in the treatment of CTCL. Brentuximab Vedotin Demonstrates Significant Clinical Activity in Relapsed or Refractory Mycosis Fungoides with Variable CD30 Expression (Abstract #797) The ongoing phase II clinical trial is enrolling CTCL patients with mycosis fungoides (MF) or Sezary syndrome. Twenty patients have been enrolled to date with a median of six prior systemic therapies. The primary endpoint of the trial is clinical response rate. Secondary endpoints include correlation of clinical response with CD30 expression levels, duration of response and safety. The study was led by principle investigator Dr. Youn H. Kim from Stanford University School of Medicine in Stanford, CA, and was presented in an oral session. Key findings include: Results of a Phase II Trial of Brentuximab Vedotin (SGN-35) for CD30+ Cutaneous T-Cell Lymphomas and Lymphoproliferative Disorders (Abstract #3688) Data … Continue reading →

ATLANTA--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today summarized ADCETRIS (brentuximab vedotin) and CD30 expression data in non-Hodgkin lymphomas and other malignancies from multiple presentations at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. Highlights include encouraging interim data from a phase II clinical trial of ADCETRIS in non-Hodgkin lymphoma and long-term follow up from a pivotal clinical trial of ADCETRIS in relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). In addition, investigators presented data describing the expression of CD30 in DLBCL and case studies on ADCETRIS in patients with systemic mastocytosis. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. This collection of data from both corporate studies as well as investigator research into CD30 and the clinical role of ADCETRIS in non-Hodgkin lymphomas add to a growing body of evidence that ADCETRIS has potential in a broad array of CD30-positive malignancies, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The numerous data sets at ASH also reinforce our development strategy for the program and overall vision for ADCETRIS in the treatment of patients with significant unmet medical needs. A Phase II Study … Continue reading →

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced key presentations of clinical and scientific data at the 54th Annual Meeting of the American Society of Hematology (ASH), being held in Atlanta, Georgia, from December 8-11, 2012. The presentations include two oral presentations and 10 poster presentations for ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, three poster presentations for FOLOTYN (pralatrexate injection), and four poster presentations for belinostat, a novel histone deacetylase (HDAC) inhibitor. Nearly 20 presentations at ASH will feature clinical and scientific data for Spectrums commercial products, ZEVALIN and FOLOTYN, as well as our late-stage drug candidate, belinostat, said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. The ZEVALIN-related abstracts demonstrate its use in a multitude of diverse settings and potential indications in which this product is being tested, including transplantation, its use in elderly patients, in frontline treatment and in the treatment of relapsed/refractory disease, as well as in new drug combinations. The FOLOTYN-related abstracts include presentations on new, synergistic combinations with other approved agents and in difficult-to-treat indications, such as HTLV-1-induced leukemia/lymphoma, … Continue reading →