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.
Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, has been named a winner of the 2017 Family Business Award by the Triangle Business Journal, a multimedia source for local business news, research and events in the Raleigh, Durham and Chapel Hill region of North Carolina, where Rho is headquartered.
eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulators (STRs) for the treatment of cancer, today announced that data presented in a poster session at the American Society of Hematology (ASH) 59th Meeting and Annual Exhibition demonstrate clinical activity, including one partial response, for the company’s lead product candidate, eFT508.
Kura Oncology, Inc., (Nasdaq:KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today reported positive, preliminary results from a Phase 2 clinical study of its lead candidate tipifarnib in patients with chronic myelomonocytic leukemia (CMML).
Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, today announced that the three additional patients that were enrolled into the Phase II COBALT trial of CoversinTM in paroxysmal nocturnal hemoglobinuria (PNH), considered together with the earlier five patients, met the primary endpoint.
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive top-line results from MediciNova’s clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS).
COMPASS Pathways, a healthcare company dedicated to accelerating patient access to evidence-based innovation in mental health, announced recently that it is partnering with Worldwide Clinical Trials to conduct a major programme of late-stage clinical trials for psilocybin therapy for treatment-resistant depression
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) today announced positive top-line results from a Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis (NASH).
TransPerfect Life Sciences, a leading provider of technologies and services to support clinical trials and product development for the biopharmaceutical industry, today announced the hiring of Christine Morris and Jay Smith, two e-clinical and life sciences veterans, to its leadership team.
Plasticell, a developer of innovative stem cell technologies and cell therapies, recently announced it will collaborate with Anthony Nolan, a leading research organisation dedicated to saving the lives of people with blood cancers, to progress clinical development of Plasticell’s ex vivo expanded cord-blood derived hematopoietic stem cell product.
Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today announced new data from its first Phase 3 trial (Study 1) of its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of Dravet syndrome.
Nabriva Therapeutics plc (NASDAQ:NBRV), a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today announced that it has completed enrollment in its second lefamulin evaluation against pneumonia (LEAP 2) Phase 3 clinical trial.
Progress in pancreatic adenocarcinoma trials is sluggish, which is often attributed to low clinical trial recruitment and substandard design. This results in an inadequate understanding of this notoriously difficult-to-treat disease and poor outcomes for patients, according to GlobalData, a leading data and analytics company.
Crucial Data Solutions, Inc.™, together with strategic partner Zircon Technologies™, announce the official release of a software solution to accelerate the clinical trials process.
Almirall, S.A (ALM), recently announced positive top-line results from the Phase IV, ASCENT trial for Tudorza (aclidinium bromide 400μg, twice-daily), a long-acting muscarinic antagonist (LAMA).