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 … Continue reading →

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 →