Category Archives: FDA Stem Cell Trials

Ohio State University Comprehensive Cancer The pill, developed by The Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute, works by targeting a particular enzyme within the cancer cells that feeds their growth. Its called ibrutinib, and its a potential breakthrough in treating chronic lymphocytic leukemia (CLL) that could leave patients with fewer side effects than chemotherapy. In research published in the New England Journal of Medicine (NEJM), scientists report that the experimental drug, which differs from broadly acting chemotherapy agents by specifically targeting certain cancer-causing processes, significantly prolongs the life of patients. Ibrutinib is currently being tested on tumors that target the bodys immune system, such as CLL and mantle cell lymphoma (MCL). CLL is the second most common form ofleukemia among adults in the U.S., and about 15,000 Americans, most of whom are elderly, are diagnosed with the blood and bone marrow cancer every year. The drug is the first to bind to and block the activity of a protein known as Brutons tyrosine kinase (BTK), which plays an important role in helping immune cell tumors, which develop from abnormally growing blood stem cells, to grow. Once ibrutinib binds to the immune systems B-cells, … Continue reading →

Pluristem Therapeutics Inc.(PSTI) recently announced that it has provided the US Food and Drug Administration (:FDA) with additional information regarding the clinical trials for intermittent claudication (:IC) pursuant to a clinical hold on the phase II IC study earlier this month. We remind investors that on Jun 4, 2013, the company was informed that the FDA has placed a clinical hold on a phase II IC study following a serious allergic reaction in one of the patients who required subsequent hospitalization. The patient was discharged the next day after the symptoms were managed. Pluristem pointed out that the patient was suffering from multiple diseases which might have affected the severity of the allergic reaction. Although the 30-day period within which the FDA is expected to provide a letter to the company containing a list of questions and information required is yet to expire, Pluristem has already provided the agency with additional information so as to speed up the review and resolution of the issues. The company provided information from a database compiled from previous clinical studies. Meanwhile, as the study is being conducted both in the US and Germany, Pluristem informed the Paul-Ehrlich-Institute (PEI) in Germany about the clinical hold … Continue reading →

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today highlighted multiple ADCETRIS (brentuximab vedotin) data presentations at the 12th International Conference on Malignant Lymphoma (ICML) being held June 19-22, 2013 in Lugano, Switzerland. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL and conditional marketing authorization by the European Commission in October 2012 for relapsed or refractory HL and relapsed or refractory sALCL. Four oral and two poster presentations at ICML illustrated the broad clinical development program for ADCETRIS, including oral presentations describing the ongoing global phase 3 ECHELON-2 trial in frontline mature T-cell lymphoma (MTCL) and data from a phase 2 trial in patients with relapsed MTCL. In addition, an oral presentation included the first report of data from an investigator-sponsored trial evaluating ADCETRIS in first-relapse HL patients as part of a pre-autologous stem cell transplant regimen. With last years European conditional marketing authorization supporting the use of ADCETRIS as a treatment for patients with relapsed HL and sALCL, this meeting provides us with an opportunity to share … Continue reading →

BOUDRY, Switzerland--(BUSINESS WIRE)-- Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation (CELG), today announced that results from two studies evaluating the combination of REVLIMID (lenalidomide) and rituximab in various non-Hodgkins lymphomas were presented at the 12th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. The increasing volume of clinical evidence evaluating combinations utilizing REVLIMID plus rituximab provide us powerful insight into the potential of antibody-dependent cellular cytotoxicity in lymphomas, and the potential of these novel combinations in patients in subtypes with a poor prognosis, said Jean-Pierre Bizzari, M.D., Executive Vice President, Hematology and Oncology for Celgene Corporation. We look forward with great interest to further data from the studies presented at this years ICML conference. Lenalidomide plus rituximab in patients with previously untreated follicular lymphoma In this preliminary report from a phase II study, conducted by the Alliance for Clinical Trials in Oncology, and presented by Peter Martin, M.D., Assistant Professor of Medicine at Weill Cornell Medical College, patients with untreated follicular lymphoma, including those with grade 1-3a, stage 3-4 or bulky stage 2 and FLIPI 0-2 disease, were given lenalidomide (20mg/day on days 1-21 of each 28-day cycle) for 12 cycles and rituximab (four weekly doses of … Continue reading →

Ibrutinib, seen here, is being considered a breakthrough drug that might one day replace chemotherapy. STORY HIGHLIGHTS (TIME.com) -- It's called ibrutinib, and it's a potential breakthrough in treating chronic lymphocytic leukemia (CLL) that could leave patients with fewer side effects than chemotherapy. In research published in the New England Journal of Medicine (NEJM), scientists report that the experimental drug, which differs from broadly acting chemotherapy agents by specifically targeting certain cancer-causing processes, significantly prolongs the life of patients. Ibrutinib is currently being tested on tumors that target the body's immune system, such as CLL and mantle cell lymphoma (MCL). CLL is the second most common form of leukemia among adults in the U.S., and about 15,000 Americans, most of whom are elderly, are diagnosed with the blood and bone marrow cancer every year. The drug is the first to bind to and block the activity of a protein known as Bruton's tyrosine kinase (BTK), which plays an important role in helping immune cell tumors, which develop from abnormally growing blood stem cells, to grow. Once ibrutinib binds to the immune system's B-cells, it prevents tumors growing in these cells from signaling for the nutrients they need to grow and … Continue reading →

Newswise LA JOLLA, Calif., June 17, 2013 The first experimental drug to boost brain synapses lost in Alzheimers disease has been developed by researchers at Sanford-Burnham Medical Research Institute. The drug, called NitroMemantine, combines two FDA-approved medicines to stop the destructive cascade of changes in the brain that destroys the connections between neurons, leading to memory loss and cognitive decline. The decade-long study, led by Stuart A. Lipton, M.D., Ph.D., professor and director of the Del E. Webb Center for Neuroscience, Aging, and Stem Cell Research, who is also a practicing clinical neurologist, shows that NitroMemantine can restore synapses, representing the connections between nerve cells (neurons) that have been lost during the progression of Alzheimers in the brain. The research findings are described in a paper published June 17 by the Proceedings of the National Academy of Sciences of the United States of America (PNAS). The focus on a downstream target to treat Alzheimers, rather than on amyloid beta plaques and neurofibrillary tanglesapproaches which have shown little successis very exciting because everyone is now looking for an earlier treatment of the disease, Lipton said. These findings actually mean that you might be able to intercede not only early but also … Continue reading →

June 17, 2013 The first experimental drug to boost brain synapses lost in Alzheimer's disease has been developed by researchers at Sanford-Burnham Medical Research Institute. The drug, called NitroMemantine, combines two FDA-approved medicines to stop the destructive cascade of changes in the brain that destroys the connections between neurons, leading to memory loss and cognitive decline. The decade-long study, led by Stuart A. Lipton, M.D., Ph.D., professor and director of the Del E. Webb Center for Neuroscience, Aging, and Stem Cell Research, who is also a practicing clinical neurologist, shows that NitroMemantine can restore synapses, representing the connections between nerve cells (neurons) that have been lost during the progression of Alzheimer's in the brain. The research findings are described in a paper published June 17 by the Proceedings of the National Academy of Sciences (PNAS). The focus on a downstream target to treat Alzheimer's, rather than on amyloid beta plaques and neurofibrillary tangles -- approaches which have shown little success -- "is very exciting because everyone is now looking for an earlier treatment of the disease," Lipton said. "These findings actually mean that you might be able to intercede not only early but also a bit later." And that means … Continue reading →

NEW YORK, June 17, 2013 /PRNewswire/ --Reportlinker.com announces that a new market research report is available in its catalogue: Global Gene Therapy Market Analysis http://www.reportlinker.com/p0324817/Global-Gene-Therapy-Market-Analysis.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy Gene therapy is the treatment of a disease by replacing, altering, or supplementing a gene that is absent or abnormal and whose absence or abnormality is causing the disease. It has evolved as one of the most sought after research objectives for 'difficult to cure' diseases. The gene therapy market in spite of presenting few marketable products and being nascent in terms of revenue generation holds tremendous growth potential. As per a new estimation carried out in our latest study, the global gene therapy industry has the potential to become a multi-million dollar industry by the end of 2017 as new products, especially those in the advanced stage of clinical studies or with pending approvals, may enter the market to boost the growth. According to RNCOS' new research report, "Global Gene Therapy Market Analysis", major focus has been made on the ongoing clinical trials for the development of innovative products. Majority trials are focused on oncology and they prove promising on global scale for US. In this context, the study provides a comprehensive overview of … Continue reading →

STOCKHOLM--(BUSINESS WIRE)-- Incyte Corporation (INCY) today announced results from two ongoing clinical trials of Jakafi (ruxolitinib), an oral JAK1 and JAK2 inhibitor that is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), that were presented at the 18th Congress of the European Hematology Association (EHA) in Stockholm, Sweden. In a three-year follow-up analysis of the Phase III COMFORT-II study, treatment with Jakafi, which is marketed as Jakavi by Novartis outside the United States, was associated with improved overall survival and sustained reductions in spleen size compared to best available therapy. In a separate exploratory analysis of bone marrow fibrosis data from an ongoing Phase I/II single-arm, open-label clinical trial, by 48 months of treatment, Jakafi stabilized or reversed fibrosis of the bone marrow in 56 percent and 22 percent, respectively, of patients with MF, a magnitude of an effect not seen historically with best available therapy. Results of these studies represent the continuing evolution in our understanding of the clinical benefits of Jakafi for patients with intermediate or high-risk myelofibrosis and further support my confidence that long-term treatment with Jakafi may modify this progressive and life-threatening blood cancer, stated Srdan Verstovsek, M.D., Ph.D., Professor, Department of … Continue reading →

San Diego, CA (PRWEB) June 13, 2013 Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and clinical development, announced today they have entered into a Global Distribution Agreement with Life Technologies Corporation. Under the terms of this agreement, Life Technologies will exclusively offer Stemedicas ischemic tolerant allogeneic adult mesenchymal stem cells (itMSCs) and neural stem cells (itNSCs) for sale worldwide to research, academic institutions and corporations both in the United States and internationally. Stemedica stem cell lines will be sold under the brand name Gibco and will be available to purchase for research initiatives beginning Q2, 2013. The label will also carry the name of Stemedica as the manufacturer of the cell lines. Life Technologies is a global biotechnology company with customers in more than 180 countries, providing more than 50,000 end-to-end solutions for customers in the fields of scientific research, genetic analysis and applied sciences. The Companys systems, reagents and consumables represent some of the most cited brands in scientific research. Life Technologies employs approximately 10,000 people and upholds its ongoing commitment to innovation with more than 5,000 patents and exclusive licenses. The Company had sales of $3.8 billion in 2012. We are honored … Continue reading →