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.
Ciox, a leading health technology company, recently announces the general availability of Ciox HealthSource Vault, a unified member-centric data repository designed for health plans, self-funded employers, life sciences companies and government agencies that require ubiquitous access to clinical data.
Lyndra Therapeutics, which aims to make daily pills a thing of the past, has released positive results from a pharmacokinetics (PK) study of its ultra-long-acting oral dosage form.
Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing novel biologic therapies to treat eye diseases, today announced that recruitment into the Company’s ongoing Phase 2b trial of OPT-302 for wet age-related macular degeneration (AMD) is complete.
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the first Company sponsored Phase I study of its novel, orally available and covalently-bound Bruton Tyrosine Kinase (BTK) inhibitor, TG-1701, is open for enrollment for patients with relapsed or refractory B-cell malignancies.
Amgen (NASDAQ: AMGN) today announced the final report of the Open-Label Study of Long-TERm Evaluation Against LDL-C (OSLER-1), demonstrating long-term treatment with Repatha® (evolocumab) was associated with robust and consistent reductions in low-density lipoprotein cholesterol (LDL-C), with no increase in overall rates of adverse events over time and no neutralizing antibodies
Aptinyx Inc. (NASDAQ: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced that exploratory clinical studies of its novel NMDA receptor (NMDAr) modulator, NYX-2925, provide the first evidence that oral dosing of the product candidate induces pharmacodynamic activities in humans that are understood to be NMDAr-mediated.
Nkarta Therapeutics, a privately-held cell therapy company developing Natural Killer (NK) cell therapies to fight cancer, today announced preclinical data highlighting the anti-cancer activity of engineered NK cells in a presentation at the Society of Immunotherapy for Cancer meeting being held in Washington D.C.
OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, today announced initial results from the Phase 1a dose escalation portion of a Phase 1a/b trial of etigilimab, the company’s anti-TIGIT antibody.
InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced that patient enrollment has been completed in the phase IIb study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients suffering from moderate or severe Hidradenitis Suppurativa (HS).
MMS Holdings Inc. (MMS) – an award-winning, data-focused CRO – announced that the company has successfully assisted Korea-based Vivozon Inc. in achieving a Fast Track Designation from the Food and Drug Administration (FDA) for VVZ-149, a non-opioid pain killer.
RF Health, a CRF Bracket company, the leading provider of patient-centered eSource technology solutions for the life sciences industry, today announced the awarding of two new contracts by top-20 pharma companies, which will see the company’s innovative eCOA solutions used to capture patient reported outcomes in 15 global dermatology trials.
Crucial Data Solutions announces the latest update to their native mobile app for clinical trial data collection and management. TrialKit™, an eClinical platform, has incorporated Apple’s biometric technologies for user authentication. Now, iPhone users with compatible generation devices can quickly and easily sign in to the app via facial recognition or fingerprint recognition.
Sharp, a global leader in contract packaging and clinical supply services, part of UDG Healthcare, confirmed a preferred partner agreement with innovative sterile manufacturer Berkshire Sterile Manufacturing (BSM). As part of the agreement, Sharp will offer sterile fill/finish to augment its existing clinical manufacturing service to the pharmaceutical, biotech and clinical research sectors.
Abeona Therapeutics Inc, a leading clinical-stage biopharmaceutical company focused on developing novel gene and cell therapies for life-threatening rare diseases, and REGENXBIO (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced a license agreement to REGENXBIO’s NAV AAV9 vector for the treatment of four diseases: Sanfilippo syndrome type A (MPS IIIA), Sanfilippo syndrome type B (MPS IIIB), Infantile Batten Disease, also known as neuronal ceroid lipofuscinosis type 1 (CLN1 Disease), and Juvenile Batten Disease, also known as neuronal ceroid lipofuscinosis type 3 (CLN3 Disease).