It has been approximately 10 years since Bayer’s medicine Nexavar was approved for the treatment of advanced hepatocellular (liver) cancer. Despite all of the research and money put into this effort since then, there has not been another drug approved for this disease. However, in April 2017, patients did finally see a new treatment (Stivarga) approved by FDA.
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.
Genelux is an oncolytic virus company that was formed in 2001 and has been conducting clinical trials since 2009. The company completed four Phase 1 studies which have enabled it to design what CEO Thomas Zindrick describes as an advanced clinical program.
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.
Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, has now completed enrollment in its Phase 1 dose escalation study of Atossa's proprietary Endoxifen
Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that the Company has received notice of allowance for a U.S. Patent for "Method of Enhancing Specific Immunotherapies in Cancer Treatment"
Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its Lyme disease vaccine candidate VLA15.
Retrophin, Inc. (NASDAQ:RTRX) today announced that the first patient has been dosed in the FORT (FOsmetpantotenate Replacement Therapy) Study, an international, registrational Phase 3 clinical trial assessing the safety and efficacy of RE-024 (fosmetpantotenate) for the treatment of pantothenate kinase-associated neurodegeneration (PKAN), a rare, genetic neurological disorder.
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced positive top-line results from IGNITE4, the Company's phase 3 clinical trial evaluating the efficacy and safety of twice-daily intravenous (IV) eravacycline compared to meropenem for the treatment of patients with complicated intra-abdominal infections (cIAI).
Santen Pharmaceutical Co. Ltd. (Santen) and TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) (TRACON) today announced that Santen has initiated a Phase 2a clinical study of DE-122 in patients with wet age-related macular degeneration (AMD).
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced the completion of two Phase 3 placebo-controlled studies evaluating the efficacy, safety and pharmacokinetics of EXPAREL® (bupivacaine liposome injectable suspension) as a single-dose nerve block for prolonged regional analgesia.
Crucial Data Solutions (CDS) is excited to announce a real solution to make clinical trial sites and study participants truly unified. TrialKit, a native mobile app, empowers investigators and clinicians to build, deploy, and manage regulatory compliant (FDA 21 CFR Part 11) research studies entirely on mobile devices.
Celyad SA/NV (EURONEXT Brussels:CYAD) (EURONEXT Paris:CYAD) (NASDAQ:CYAD), a leader in the discovery and development of CAR-T cell therapies, today announced the initiation of the SHRINK trial, a third clinical trial with its lead product candidate CYAD-01 (CAR-T NKG2D), targeting metastatic colorectal patients.
Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, today announced that the Company has submitted to the U.S. Food and Drug Administration (FDA) for review a proposed pivotal Phase 3 protocol for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy (Inhaled AAT) for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).
Provention Bio, Inc., a clinical stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics aimed at intercepting and preventing immune-mediated diseases, announced recently the in-licensing of an enterovirus vaccine platform, which the company is initially developing to reduce the onset of type 1 diabetes (T1D) by vaccinating at-risk populations against coxsackievirus B (CVB) infection.
Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced today guidance from a recent Type-C meeting with the FDA which has recommended accelerating the EB-101 program into a pivotal Phase 3 trial.
Today Life Science Connect (LSC), a leading B2B marketing services and engagement company, announced the acquisition of Industry Standard Research (ISR), also known as ISR Reports.
CymaBay Therapeutics, Inc. (Nasdaq:CBAY), today announced positive interim results from its ongoing low-dose Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC), a life-threatening and life-limiting chronic cholestatic liver disease.