Clinical news roundup for the week of December 4, 2016 with information on Almac partnering with inVentiv on IRT, ERT acquiring Exco In Touch, and the 21st Century Cures bill passing the Senate and moving on to the White House.
Clinical news roundup for the week of October 3, 2016 with information on Biotrial facility in the U.S., clinical trials in Australia, pancreatic cancer research, minority enrollment in trials, and cardiac gene therapy.
Clinical news roundup for the week of August 22, 2016 with information on the Bioclinica acquisition by Cinven, SCRS Eagle Award finalists, supporting kids with brain tumors, reducing risk in adaptive trials, Zika testing in humans, and more.
Clinical news roundup for the week of August 8, 2016 with articles on using pets in clinical trials, the Quintiles/DaVita alliance, the benefits and pitfalls of data sharing, and the Orphan Drug Act.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
Covance was approached by a European client that was considering the acquisition of an early-stage ovarian cancer therapy product.
Oncology is the number one focus of global drug development, accounting for $65 billion in sales worldwide in 2013 and projected to grow 50 percent in the next five years.1 New treatments, new diagnostics and new medical protocols are beginning to unravel some of the scientific basis and pathways of this disease, with measurable impacts on disease progression and quality of life of survivors.
Assessment of ECGs during the development of oncology compounds is challenging. By THIJS van IERSEL, MD, Clinical Pharmacologist and Senior Director, Global Scientific Affairs, PRA Health Sciences; BORJE DARPO, MD, PhD, Chief Scientific Officer, iCardiac Technologies Inc.; GERD AROLD, MD, Senior Director, Global Scientific Affairs, PRA Health Science
Oncologists and their patients have had reason recently to be encouraged by the launch of immune checkpoint inhibitors (ICIs) for the treatment of several difficult-to-treat diseases, including metastatic melanoma and non-small cell lung cancer. These novel agents activate the human immune response against antigens expressed on tumor cells, and the science has generated excitement among physicians, patients, the media and researchers.
The scientific progress being made in cancer research has never been more encouraging or more rewarding. Yet, virtually all oncology drug sponsors face an uphill battle in what one would expect to be the easiest part of the research process: recruiting patients for clinical trials. Despite the seriousness of the diagnosis—or perhaps because of it—only three percent of adult patients with cancer participate in clinical trials. As a result, under-enrollment is common.
TruTag Technologies, a leader in fabrication of nano-porous silica, product authentication, brand security, and data intelligence solutions, recently announced that it has entered into a strategic partnership with Spinnaker Biosciences, a biotechnology company focused on the development of proprietary technology for controlled/sustained release drug delivery.
Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused clinical stage biotechnology company, today announces the successful completion of Cohort 3 and initiation of Cohort 4 in the company’s Phase I clinical study of CLR 131 in patients with relapsed and refractory multiple myeloma.
Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today announced that the Independent Data Monitoring Committee (IDMC) for the company’s pivotal Phase 3 ADAPT clinical trial of rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of metastatic renal cell carcinoma (mRCC) has recommended that the study be discontinued for futility based on its planned interim data analysis.
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational intratumoral therapy, G100, for the treatment of follicular non-Hodgkin’s lymphoma.
Celerion, continues to grow in response to the evolving needs of early clinical research. With the increasing focus on evaluating drug effects in relevant patient populations earlier in development, Celerion is pleased to announce that Dr. Marc Hoffman has joined the company as Chief Medical Officer. Dr. Hoffman will have responsibility for leading the global medical staff and providing medical oversight and expertise to support early clinical research studies.
XBiotech Inc. (NASDAQ:XBIT) today announced that an Independent Data Monitoring Committee (IDMC) has performed a prospectively planned, unblinded analysis of the Phase 3 XCITE study for the Company’s novel candidate antibody therapy for colorectal cancer.
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the last patient enrolled in the Phase III study with BEKINDA® 24 mg for the treatment of acute gastroenteritis and gastritis (the GUARD study) has completed the treatment course and observation period for the primary endpoint evaluation.
Bionomics Limited, a biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of diseases of the central nervous system (CNS) and cancer, advises that its cancer drug candidate BNC105 will be evaluated in a combination trial with blockbuster immune-oncology drug Keytruda.
Celyad (Euronext Brussels:CYAD) (Euronext Paris:CYAD) (NASDAQ:CYAD), a leader in the discovery and development of engineered cell-based therapies, today announced a further step in the CAR-T NKR-2 THINK trial with the registration of a first refractory Multiple Myeloma patient.
Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “The Company”), a leader in precision diagnostics for oncology, announced today that its hereditary cancer panel, Focus::HERSite™, for breast and ovarian cancer, has been selected by a global pharmaceutical company for a 1,000+ patient clinical study.
TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration (AMD) and fibrotic diseases, announced today that it has initiated patient dosing in its Phase 3 TAPPAS (TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) trial of TRC105.
Clintec recently announces the launch of its new brand identity - reflected in their newly created website. This in part marks Clintec’s 20th anniversary and the achievement of significant milestones following another year of substantial growth, together with a succession of key appointments that have enhanced the global leadership team.
Boehringer Ingelheim recently announced a collaboration with Weill Cornell Medicine to identify new treatment approaches forchronic obstructive pulmonary disease (COPD) in order to develop novel treatments that could possibly halt or even reverse the progression of the disease process
RCSI (Royal College of Surgeons in Ireland) and Almac Discovery, a biopharmaceutical company focused on discovering and identifying innovative therapeutics for the treatment of cancer, have recently announced a major research collaboration that aims to gain a new understanding of how to target tumour cells that are resistant to cancer therapies and cause cancer to spread to other parts of the body.