|Lilly Announces CYRAMZA Phase III Meets Primary Endpoint Of Overall Survival; FDA Advisory Committee to Review Natpara Biologics License Application-Halts NPS Pharma Trading|
|By David Fowler|
|Friday, 12 September 2014 18:37|
Eli Lilly and Company (NYSE: LLY) announced the RAISE trial, a Phase III study of ramucirumab (CYRAMZA™) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival. The global, randomized, double-blind study compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin and a fluoropyrimidine in the first-line setting.
RAISE showed a statistically significant improvement in overall survival in patients treated with ramucirumab plus FOLFIRI compared to placebo plus FOLFIRI. The study also showed a statistically significant improvement in progression-free survival in the ramucirumab-plus-FOLFIRI arm compared to the placebo-plus-FOLFIRI arm. The most common (>5% incidence) grade >/=3 adverse events occurring at a higher rate on the ramucirumab-plus-FOLFIRI arm compared to the control arm were neutropenia, fatigue, hypertension, and diarrhea.
Despite advances in treating colorectal cancer in recent years, the mortality rate remains significant. It is the fourth leading cause of cancer death worldwide and the second leading cause of cancer death in the U.S.
"Patients with metastatic colorectal cancer – particularly those in the second-line setting – continue to need new treatment options that improve survival," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "We are pleased that the RAISE study demonstrated a survival benefit and are hopeful that ramucirumab will become a new anti-angiogenic treatment option after first-line bevacizumab-containing therapy for metastatic colorectal cancer patients."
Lilly plans to present data from the RAISE trial at a scientific meeting in 2015 and expects to initiate regulatory submissions in the first half of 2015.
Dr. Gaynor added, "We now have four Phase III ramucirumab trials that improved survival in three of the world's most common and deadly cancers--gastric, lung, and colorectal--supporting global regulatory submissions in multiple indications. The RAISE data also build on Lilly's growing presence in gastrointestinal cancer therapy."
Ramucirumab is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds VEGF Receptor 2 and blocks binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. VEGF Receptor 2 is an important mediator in the VEGF pathway.i,ii In an in vivo animal model, ramucirumab inhibited angiogenesis. Angiogenesis is a process by which new blood vessels form to supply blood to normal healthy tissues as well as tumors, enabling the cancer to grow.
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, announced NASDAQ has halted trading of the company's common stock. The U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) is meeting today to review the company's Biologics License Application (BLA) for Natpara® (rhPTH [1-84]). Natpara is a bioengineered replacement therapy for endogenous parathyroid hormone (PTH) that NPS Pharma has developed for the treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of PTH.
EMDAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders and makes appropriate recommendations to the FDA. The committee's recommendation will be considered by the FDA in its review of the company's BLA for Natpara. The Prescription Drug User Fee Act (PDUFA) date for completion of the review of the Natpara BLA is October 24, 2014.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of diagnostic and therapeutic interventions for Alzheimer's disease, Parkinson's disease and orphan ophthalmological disorders, today announced that it has completed enrollment of the originally planned 72 patient LP-002 clinical study to assess the commercial feasibility of the company's flagship Alzheimer's blood diagnostic LymPro Test®.
Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that the Company is participating in an MIS-based training course hosted by the International Society for the Advancement of Spine Surgery (ISASS), and co-chaired by Anthony Yeung, MD and James J Yue, MD.
CNS Response, Inc. (OTCBB:CNSO) George C. Carpenter, CEO of CNS Response will be speaking at the upcoming Frost and Sullivan Growth, Innovation and Leadership conference: "The Future of Value Based Care Delivery," as part of the expert panel on "Prospering in a Radically New Healthcare Landscape."
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver and intestinal diseases, announced today its support for International Primary Biliary Cirrhosis (PBC) Day, taking place September 14, 2014.
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on developing targeted cancer therapies for genetically-defined populations, today reported financial results for the quarter ended June 30, 2014 and recent business highlights.
Mountain High Acquisitions Corp. (OTCQB: MYHI), a strategic real estate holding company whose primary focus is the acquisition and development of commercial properties in the cannabis sector, is pleased to announce that the Company has completed all pre-closing due diligence regarding its previously announced letter-of-intent to acquire the 2.38 acre property and related structures in Pueblo, Colorado, known as the Greenhorn Property.
QLT Inc. (Nasdaq:QLTI) (TSX:QLT) today announced positive final results from its international, multi-center, Phase 1b clinical trial of repeated treatments of oral QLT091001 in subjects with Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) due to inherited genetic mutations in retinal pigment epithelium (RPE65) or lecithin:retinol acyltransferase (LRAT).
Sunshine Heart, Inc. (Nasdaq:SSH), today announced that on September 9, 2014, upon the recommendation of its Compensation Committee, the Company's independent directors approved three equity awards under Sunshine Heart's New-Hire Equity Incentive Plan, as material inducements to three individuals entering into employment with the Company.
Synthetic Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing novel anti-infective biologic and drug programs targeting specific pathogens that cause serious infections and diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to the Company's proprietary SYN-005 monoclonal antibody (mAb) combination for the treatment of Pertussis, more commonly known as whooping cough.
TriVascular Technologies, Inc. (Nasdaq:TRIV) presented three-year primary safety and performance metrics from the Ovation Pivotal Trial today at the 2014 Joint Annual Meeting of the New England Vascular Society and Eastern Vascular Society.
VG Life Sciences, (OTC Pink:VGLS) a biotechnology company, announces that one of its scientific advisors, Dr. Brett Mitchell, PhD, will give an oral presentation today on his preeclampsia research at the American Heart Association Council for High Blood Pressure Research Conference in San Francisco, California.