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.
Almac Group’s Diagnostics business unit recently announced the Journal of European Urology has published results relating to its Prostate Cancer Metastatic Assay. The publication demonstrates the assay can be used to analyse primary prostate cancer FFPE samples to identify a molecular subgroup with a high risk of developing distant metastases.
Pharmaceutical Product Development, LLC (PPD) recently announced the kickoff of its 2017 educational campaign to raise awareness about the life-changing impact of clinical research, featuring a team of PPD Heroes who share their personal stories to inspire hope.
Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology and The University of Texas MD Anderson Cancer Center, today announced a multi-year strategic alliance agreement involving multi-arm clinical trials to evaluate the safety and efficacy of TIL therapy in ovarian cancer, various sarcomas, and pancreatic cancer.
Veeva Systems recently announced Veeva Vault SiteExchange, a cloud application that allows life sciences companies, CROs, and sites to easily access and exchange information during clinical trial execution.
Veeva Systems and TransCelerate BioPharma Inc., a non-profit organization with membership comprised of global biopharmaceutical companies, recently announced TransCelerate selected Veeva Vault SiteExchange for the Shared Investigator Platform (SIP), a platform that facilitates investigative site collaboration with multiple clinical trial sponsors.
Vical Incorporated (Nasdaq:VICL) announced today that it has completed the target enrollment of 225 subjects in a Phase 2 trial of its therapeutic bivalent vaccine for herpes simplex virus type 2 (HSV-2), the leading cause of recurrent genital herpes.
Plasticell, a developer of cell therapies including hematopoietic cell replacement therapies, recently announced it has partnered with Kings College London to progress preclinical trials of its artificial blood platelet product, manufactured from pluripotent stem cells.
Motif Bio plc (Motif) (NASDAQ:MTFB), (NASDAQ:MTFBW), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced positive topline results from REVIVE-1, a global Phase 3 clinical trial of its investigational drug candidate iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).
Cellectar Biosciences, Inc. (Nasdaq:CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, today announces the Japanese Patent Office has granted a method of use patent for two of the company’s phospholipid drug conjugates (PDCs), CLR 131, the company’s lead compound, and CLR 125, each in combination with radiation and/or other therapies to treat cancer stem cells.
Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD) (“Prima” or the “Company”) today announced that approval has been granted for the third cohort of its Phase I clinical trial for IMP321 in combination with KEYTRUDA® being conducted in Australia.
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 reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC). The Company also provided perspective on its decision to continue the trial.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today reported top-line results from the company’s randomized 145-patient Phase 2 PINNACLE clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) in combination with etoposide plus either cisplatin or carboplatin chemotherapy (“chemotherapy”) in previously untreated patients with extensive-stage small cell lung cancer.
Medidata, the leading global provider of cloud-based solutions and data analytics for clinical research, recently announced that the company has agreed to acquire Mytrus, Incorporated, an e-clinical technology company specializing in patient-centered electronic informed consent (eConsent) and virtual trials.
Genentech, a member of the Roche Group, recently announced interim results from the Phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with hemophilia A and inhibitors to factor VIII.