Category Archives: FDA Stem Cell Trials

The US Food and Drug Administration (FDA) has suspended a Phase II clinical trial by Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) of its placental stem study for the treatment of intermittent claudication (calf muscle pain). The clinical hold was place after a patient suffered a serious allergic reaction which required hospitalization. Pluristem said that this was the first serious allergic event among the 74 patients enrolled in the company's clinical trials to date. It added, "This event occurred in a patient with multiple diseases which may have influenced the severity of the event. The patient was discharged from the hospital the following day, following the resolution of all her symptoms." The FDA will issue a letter within the next 30 days detailing a list of questions and requests for information from Pluristem. Pluristem chairman and CEO Zami Aberman said, "Once we receive the letter, we will work closely with the FDA to address all issues raised. We are committed to our strategy that our competitive technology advantage be involved in clinical programs for multiple indications." Published by Globes [online], Israel business news - http://www.globes-online.com - on June 4, 2013 Copyright of Globes Publisher Itonut (1983) Ltd. 2013 Read the … Continue reading →

DURHAM, N.C., June 3, 2013 (GLOBE NEWSWIRE) -- Chimerix, Inc. (CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the continued development of CMX001 as a potential medical countermeasure against smallpox, which is classified as a Category A bioterror agent by the U.S. Centers for Disease Control and Prevention. The extension of the contract provides $5 million in funding over 12 months for Chimerix to conduct animal studies that are necessary for an approval of CMX001 for treatment of smallpox infection under the U.S. Food and Drug Administration's (FDA) Animal Efficacy Rule. CMX001 is being developed as a treatment or preventive therapeutic for multiple viral diseases based on its antiviral activity against all five families of double-stranded DNA (dsDNA) viruses that cause disease in humans, including smallpox. Data from cell culture and animal models of smallpox have shown CMX001 to be highly effective against viruses in the poxvirus family. There is no antiviral agent approved for the treatment of smallpox. An antiviral is needed, in particular, for patients who cannot be vaccinated due to medical conditions that … Continue reading →

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, today announced positive results from the BELIEF trial, a pivotal, single-arm study of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) after failure of 1 prior systemic therapies. Data presented at an oral session at ASCO demonstrated the clinical activity of belinostat, a novel pan-histone deacetylase inhibitor, in treating patients (N=129) with R/R PTCL with: These data are very encouraging and demonstrate the potential clinical activity and safety of belinostat as a single agent in the treatment of patients with relapsed or refractory PTCL, said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. Despite the recent approvals of new treatments for R/R PTCL, there remains an unmet medical need with approximately 70% of patients failing current therapies, so clearly these patients need alternative effective treatment options. We are excited that Spectrum is on track to file an NDA for belinostat for this indication in 2013. In this study, Belinostat demonstrated important clinical efficacy in poor prognosis relapsed and refractory PTCL patients, said Dr. Owen A. OConnor, … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Verastem, Inc., (VSTM) focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, held a mesothelioma briefing session on Saturday morning with Dr. Dean Fennell at the annual American Society of Clinical Oncology meeting in Chicago, IL. Dr. Fennell is the Chair of Thoracic Medical Oncology at the University of Leicester, incoming President of the International Mesothelioma Interest Group (iMig) and a member of the Verastem Mesothelioma Steering Committee. Dr. Fennell presented together with Verastem Chief Medical Officer, Dr. Joanna Horobin and Head of Research, Dr. Jonathan Pachter. Asbestos is the causative agent in the vast majority of mesothelioma cases, said Dr. Fennell. Sadly, the use of asbestos continues worldwide. Due to the 10-50 year latency period from asbestos exposure to development of disease, we expect that the current trend of increasing mesothelioma incidence worldwide will continue. There is a large unmet medical need in mesothelioma and an opportunity to develop targeted agents to bring new hope to patients struggling with their disease. According to published reports there are still nearly two million tons of asbestos consumed globally each year. The incidence rate of mesothelioma is increasing in the United … Continue reading →

Sarasota, Florida (PRWEB) June 03, 2013 Guy DaSilva, MD, ABAARM, will begin conducting clinical trials for many degenerative diseases using adipose-derived stem cell therapy at the DaSilva Institute in Sarasota, Florida. The independent review board of the International Stem Cell Society will oversee the trials. Following the FDA-approved protocols, Dr. DaSilva will treat patients suffering from chronic obstructive pulmonary disease (COPD), Type 2 Diabetes, osteoarthritis, critical limb ischemia and erectile dysfunction. Furthermore, Alzheimers disease, dementia and Parkinsons disease are pending approval, and approximately five new protocols are added each month. While stem cell therapy is most often associated with the controversial use of embryonic stem cells, Dr. DaSilva will be exclusively using adult autologous stem cells, harvested from the patients own adipose (fat) tissue or bone marrow if fat is not available. Because patients are receiving their own cells, there is no risk of rejection, and success rates are far greater compared to the more contentious therapies. Autologous stem cell therapy works by mimicking the bodys natural healing process, but at a more potent, concentrated level. Stem cells, which are unspecialized cells with the potential to develop into any cell, are stored throughout the body. When disease or injury strikes, … Continue reading →

CHICAGO & OSAKA, Japan--(BUSINESSWIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502) today announced interim data from a Phase 1/2, open-label, multicenter study with ADCETRIS (brentuximab vedotin) in pediatric patients diagnosed with CD30-positive relapsed or refractory Hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Data were presented from the Phase 1 portion of the study, which evaluated the safety, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and pharmacokinetics (PK) of ADCETRIS. The results were reported during a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting held May 31 June 4, 2013 in Chicago, IL. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. This is the first clinical trial examining the use of ADCETRIS in pediatric patients, said Kathleen Neville, M.D., M.S., Director, Experimental Therapeutics in Pediatric Cancer, Childrens Mercy Hospitals and Clinics, Kansas City, MO. There is an unmet medical need for children diagnosed with relapsed or refractory HL or relapsed or refractory sALCL. We are encouraged by these early results and look forward to reporting data from the Phase 2 portion of the study when they are available. Phase I/II Study … Continue reading →

CHICAGO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today highlighted ongoing clinical development programs for ADCETRIS (brentuximab vedotin) in frontline Hodgkin lymphoma (HL) and mature T-cell lymphoma (MTCL) and progress with collaborator antibody-drug conjugate (ADC) programs that were presented at the 49th Annual Meeting of the American Society of Clinical Oncology being held May 31 June 4, 2013, in Chicago, IL. The phase 3 clinical trials, called ECHELON-1 and ECHELON-2, are evaluating ADCETRIS for the frontline treatment of HL and MTCL, including patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphoma. ADCETRIS is an ADC directed to CD30, a defining marker of HL and sALCL, which was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL. In addition, encouraging phase 1 data were presented from two ADC clinical programs being developed by Genentech, a member of the Roche Group (RO.SW) (SWX:ROG)(RHHBY), using Seattle Genetics technology. ADCs represent an innovative and growing field in the fight against cancer, which is evident by the interest in this therapeutic approach at the ASCO annual meeting, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. As the first ADC to … Continue reading →

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in oncology and hematology, today announced key presentations of clinical data that included: three ZEVALIN (ibritumomab tiuxetan)-related poster presentations, and one oral presentation and two poster presentations of clinical data for belinostat at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois, from May 31 to June 4, 2013. For more information about the ASCO annual meeting and for a complete list of abstracts, please refer to the conference Web site at http://abstract.asco.org/. The following are the key ZEVALIN and belinostat-related abstracts being presented at the ASCO conference: Sunday June 2, 2013, 8:00 AM 11:45 AM Central Time S Hall A2 S Hall A2 S Hall A2 Tuesday June 4, 2013, 8:00 AM 12:00 PM Central Time About ZEVALINand the ZEVALIN Therapeutic Regimen Go here to read the rest: Spectrum Pharmaceuticals Highlights Six Abstracts of Clinical Data at the 2013 American Society of Clinical Oncology ... … Continue reading →

HOUSTON--(BUSINESS WIRE)-- Doctors at the Texas Heart Institute (THI) at St. Lukes Episcopal Hospital (SLEH) announced that they have performed an investigational procedure on six patients in a new FDA-approved clinical trial to evaluate therapy that uses regenerative cells derived from a patients own adipose (body fat) tissue to treat a severe form of heart failure. The trial, known as ATHENA, marks the first such study in the United States using adipose-derived regenerative cells, known as ADRCs, which are harvested using a technology developed by Cytori Therapeutics, a biotechnology company that specializes in cell therapies. Previous studies in Europe have shown the safety and feasibility of the therapy. We have found that body fat tissue is a valuable source of regenerative stem cells that are relatively easy to access, said Dr. James T. Willerson, THIs president and medical director and a principal investigator in the trial. We have high hopes for the therapeutic promise of this research and believe that it will lead quickly to larger trials. The trial involves patients suffering from chronic heart failure due to coronary heart disease, which blocks blood flow to the heart, reduces the hearts oxygen supply and limits its pumping function. According to … Continue reading →

TAIPEI, Taiwan, May 16, 2013 /PRNewswire/ --TaiGen Biotechnology Company, Limited ("TaiGen") today announced that they have submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA). Approval is expected in the first half of 2014. Nemonoxacin is the first pharmaceutical product to fall under the Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs of the Economic Cooperation Framework Agreement (ECFA) between Taiwan and mainland China. It is also the first new drug from Taiwan to meet the requirements of CFDA's Category 1.1 New Drug. Drugs under this classification have to be new chemical entities (NCEs) that have not been marketed in any country in the world. Nemonoxacin, thus, represents a landmark in the continued development of cross-strait relationship between the pharmaceutical industry and regulatory agencies. Nemonoxacin is a NCE, broad spectrum antibiotic with excellent efficacy and safety profile. The NDA submission for nemonoxacin is supported by a pivotal Phase 3 trial with 532 patients in community-acquired pneumonia (CAP). The trial was conducted in both Taiwan and mainland China (441 patients from mainland China and 91 patients from Taiwan) that met all primary and … Continue reading →