Keystone Nano, a small oncology-focused company in State College, PA, recently received an IND approval from the FDA and launched its first clinical trial. While that transition from discovery to clinical is an exciting time for most companies, it is also a time of greater challenges as your product is used in humans for the first time. Jeff Davidson, CEO of Keystone Nano, has learned about many of these challenges first-hand.
Clinical news roundup for the week of May 14, 2017 with information on a new head of the FDA, inVentiv Health and INC Research merging, helping patients navigate cancer clinical trials, new standards for trial results, and more.
Samus Therapeutics is a privately-held, biopharmaceutical company focused on developing novel therapeutics and diagnostics targeting the epichaperome, a foundational protein complex emergent from multiple disease states, including oncology and neurology. “We are the ‘anti-epichaperome company,’ says Jonathan Lewis, the company’s executive chairman and CEO. “Following various forms of cellular stress, chaperome units are rewired into the epichaperome network. Targeting and disrupting the epichaperome in cancer results in cell death and in neurologic diseases, neuronal survival, with no apparent effect on normal cells.”
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.
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.
Altasciences announced today that it has signed a definitive agreement to acquire the preclinical testing business of SNBL U.S.A. The transaction is expected to be completed at the end of September.
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that the first participant has been dosed with PENNVAX®-GP in a randomized clinical trial that will evaluate its ability to drive remission of HIV infection.
Taiwan Liposome Company, Ltd. (4152.TWO; “TLC”), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of medical needs in pain management, ophthalmology, and oncology, today announced the dosing of the first patients in a Phase I/II trial for TLC590. To date, the trial has enrolled 12 patients, 3 of whom were dosed on August 13, 2018.
Gemphire Therapeutics Inc. (NASDAQ: GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and nonalcoholic steatohepatitis (NASH), announces today that the Data and Safety Monitoring Board (DSMB) at Emory University School of Medicine overseeing the investigator-led open label Phase 2a proof-of-concept trial evaluating gemcabene in pediatric patients with non-alcoholic fatty liver disease (NAFLD) has recommended that the trial be terminated due to unanticipated problems.
Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced its initiation of the first of three Phase 3 clinical trials. In this trial, known as Sulopenem for Resistant Enterobacteriaceae (SURE) 1, oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) is compared to oral ciprofloxacin in women with uncomplicated urinary tract infections (uUTI). Sulopenem is Iterum’s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant infections
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today the start of a clinical phase 3 study with its antibiotic ceftobiprole. The registration study evaluates the safety and efficacy of ceftobiprole in the treatment of patients with bacteremia (bloodstream infections) caused by Staphylococcus aureus.
North Americans were the least likely to say that they feel informed about the requirements of the General Data Protection Regulation (GDPR) out of those surveyed in the global pharmaceuticals industry, according to GlobalData, a leading data and analytics company.
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, today announced that it has reached two important milestones in its ongoing clinical trial collaboration with Incyte Corporation.
Bavarian Nordic A/S recently announced positive data from the extension study of its Phase 2 study investigating the safety and immune responses of its universal RSV vaccine, MVA-BN RSV in an older adult population.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced recently the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of a split dosing regimen for DARZALEX (daratumumab).
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus and pain by selectively targeting peripheral kappa opioid receptors, today announced the dosing of the first patient in its second pivotal Phase 3 efficacy trial (KALM™-2) of KORSUVA™ (CR845/difelikefalin) injection in hemodialysis patients suffering from moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). The global trial is expected to enroll hemodialysis patients in the U.S., Europe and some countries in the Pacific Rim region.
ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patient has been dosed in its Phase II clinical trial intended to support the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that target enrollment in the ULTIMATE I and II Phase 3 trials has been achieved. ULTIMATE I and II are two independent Phase 3 clinical trials evaluating the safety and efficacy of ublituximab (TG-1101), the Company’s glycoengineered anti-CD20 monoclonal antibody, as compared to teriflunomide, in patients with relapsing forms of Multiple Sclerosis (RMS).
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the initiation of a Phase 2 clinical study evaluating NCX 470, its novel, second-generation nitric oxide (NO)-donating prostaglandin analog, for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension by enrolling 10 patients today.