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.
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the Korean Ministry of Food and Drug Safety approved the initiation of a study to evaluate GLS-5300, Inovio’s vaccine against the MERS virus (Middle East Respiratory Syndrome), in a phase 1/2a trial.
Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the Company initiated enrollment in the Phase 2 stage of PROTECT, a combined open-label Phase 1 / blinded Phase 2 clinical trial of ProTmune™ for the prevention of acute graft-versus-host disease (GvHD) in patients with hematologic malignancies undergoing matched unrelated donor hematopoietic cell transplantation (HCT).
Pluristem Therapeutics, Inc., a leading developer of placenta-based cell therapy products, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization.
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 positive topline results from the lefamulin evaluation against pneumonia (LEAP 1) trial, which evaluated the safety and efficacy of intravenous (IV) to oral lefamulin in patients with community-acquired bacterial pneumonia (CABP).
Sanofi and Regeneron Pharmaceuticals, Inc. announced recently positive results from the Phase 3 CAFÉ study of Dupixent (dupilumab) in adults with moderate-to-severe atopic dermatitis (AD) who are inadequately controlled with or intolerant to the broad immunosuppressant drug cyclosporine A (CSA), or when this treatment is medically inadvisable.
Phrixus Pharmaceuticals, Inc. (“Phrixus”), a company focused on therapies for Duchenne muscular dystrophy (DMD) and heart failure, today announced agreements with several DMD patient organizations and Cincinnati Children’s Hospital to conduct a first clinical trial of Carmeseal-MD™’s, active pharmaceutical ingredient Poloxamer 188 NF (P-188 NF), for the treatment of DMD in non-ambulatory patients.
Bracket, a leading clinical trial technology and specialty services provider, recently welcomed Sam Whitaker as Chief Technology Officer (CTO) to its growing team.
TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials, recently announced the release of Trial Interactive 9.1, the latest version of its award-winning e-clinical platform.
OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company’s Phase 1a clinical trial of GITRL-Fc (OMP-336B11).
In a new analysis of late stage clinical trials,2-4 adults with type 2 diabetes treated with Sanofi's Toujeo® (insulin glargine 300 Units/mL, Gla-300) achieved better blood glucose stability than those on insulin glargine 100 Units/mL (Lantus®, Gla-100)
Onxeo S.A. (Euronext Paris:ONXEO) (NASDAQ Copenhagen:ONXEO), (“Onxeo” or the “Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announced top line results from the phase III ReLive trial of Livatag® (doxorubicine Transdrug™) in adult patients with unresectable hepatocellular carcinoma (HCC), intolerant to sorafenib or having progressed after a systemic therapy including sorafenib, when compared to best standard of care.
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced completion of enrollment in IGNITE3, its ongoing phase 3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem in complicated urinary tract infections (cUTI).
Immuno-Oncology (IO) looks set to become the fifth pillar of cancer treatment alongside surgery, radiotherapy, chemotherapy, and other targeted treatments according to GlobalData, a recognized leader in providing business information and analytics.
Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ:CKPT), a Fortress Biotech (NASDAQ:FBIO) company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CK-101 (also known as RX518), the Company’s third-generation epidermal growth-factor receptor (EGFR) inhibitor, for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC).