News Column

Keryx Announces Zerenex LT Phase 3 Results; Esperion Announces Initiation of a Phase 2 Clinical Study of ETC-1002

July 24, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on July 24, 2014.

{nfg}Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced the publication of results from the long-term, randomized, active control Phase 3 study of Zerenex (ferric citrate), the Company's investigational oral ferric iron-based phosphate binder, for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis. The PERFECTED study (PhosphatE binding and iRon delivery with FErric CiTrate in EsrD) was published online today in the Journal of the American Society of Nephrology (JASN).



This Phase 3 study was a multicenter, randomized, open-label trial in 441 ESRD patients on hemodialysis or peritoneal dialysis designed to determine the safety and efficacy of Zerenex as a treatment to reduce serum phosphorus as well as raise iron stores and reduce intravenous (IV) iron and erythropoietin-stimulating agents (ESA) usage.



Zerenex met the study's primary end-point demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Placebo Control Period. Using a sequential gatekeeping strategy for the key pre-defined secondary end-points, Zerenex also demonstrated statistically significant increases in serum ferritin and transferrin saturation (TSAT), and significant reductions in the use of IV iron and ESAs, versus an active control of Renvela® (sevelamer carbonate) and/or Phoslo® (calcium acetate) over the 52-week Active Control Period of the study. In addition, mean hemoglobin levels were higher in subjects treated with Zerenex as compared to subjects treated with active control.



"Zerenex effectively reduces serum phosphorus levels within the KDOQI range (3.5 mg/dL to 5.5 mg/dL) while having the additional patient benefits of increasing iron stores and decreasing the need for IV iron and ESAs, while maintaining hemoglobin levels," said Julia Lewis, MD, lead investigator, nephrologist and Professor of Medicine at Vanderbilt University Medical Center. "If approved, the combined benefits of Zerenex would be of value for patients, health care professionals and the healthcare system."



The Company's New Drug Application (NDA) for Zerenex is currently under review by the U.S. Food and Drug Administration (FDA).



Ron Bentsur, Chief Executive Officer of Keryx, commented, "We are very pleased with the publication of the Phase 3 PERFECTED study results in a premier peer-reviewed nephrology journal and are encouraged by Zerenex's potential differentiated product profile." Mr. Bentsur added, "We thank the investigators and patients who participated in this study and look forward to potentially bringing Zerenex to market in the U.S."



Phosphorus Control is Necessary for Most ESRD Patients on Dialysis -- In the United States, according to data from the U.S. Renal Data System, there are currently approximately 600,000 ESRD patients, with the number of ESRD patients projected to rise in the future. The majority of ESRD patients in the United States, more than 400,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are associated with secondary hyperparathyroidism, renal osteodystrophy, soft tissue mineralization and an increase in adverse cardiovascular events. Hyperphosphatemia is ubiquitous in ESRD, with the majority of the patients requiring chronic treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels.



Zerenex Administration Over 52 Weeks Increased Iron Stores -- In addition, approximately seventy percent of dialysis patients are truly or functionally iron depleted, suffer from anemia and require treatment with IV iron and/or ESA injections. The newly published clinical trial results show that, in addition to its efficacy as a phosphate binder, Zerenex also significantly raises iron stores as measured by serum ferritin and TSAT.



The results showed Zerenex demonstrated a statistically significant treatment difference versus the active control group in mean change in serum ferritin (+306 ng/mL vs. +19 ng/mL) and TSAT (+8% vs -1.2%) from baseline (day 0) to week 52. In the PERFECTED study, subjects randomized to receive Zerenex required significantly lower dosages of IV iron and ESA; and hemoglobin levels were higher in Zerenex treated patients than in those receiving active control.



The investigators cited an analysis of the trial results that indicated that the projected reduction in the need for IV iron and ESA use would result in significant pharmaco-economic benefits. In addition, the investigators wrote, "one would postulate that decreased IV iron and ESA usage could result in decreased nursing time to administer IV medications which could be redirected to other aspects of patient care and decreased risk of infections due to fewer IV injections." In the PERFECTED study, fewer serious adverse events (SAEs) due to infection were seen in the subjects randomized to Zerenex compared to active control.



The authors noted that, if approved, Zerenex would be the only phosphate binder that also increases iron stores and decreases IV iron and ESA use.







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Esperion Therapeutics, Inc. (Nasdaq: ESPR)
, a clinical-stage biopharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers, today announced dosing of the first patient in its Phase 2 clinical study of ETC-1002 in patients with hypercholesterolemia and hypertension, ETC-1002-014. The company expects to announce top-line results from the study in the second quarter of 2015.



“Many patients with high LDL-cholesterol levels also have hypertension. This clinical study will help to further elucidate the LDL-cholesterol lowering efficacy, safety and tolerability profile of ETC-1002 in patients with both hypercholesterolemia and hypertension,” said Tim M. Mayleben, president and chief executive officer of Esperion.



The randomized, double-blind, parallel group, multicenter ETC-1002-014 study is evaluating parallel doses of ETC-1002 in approximately 144 patients. The primary objective of the study is to assess the LDL-cholesterol lowering efficacy of ETC-1002 monotherapy versus placebo in patients with both hypercholesterolemia and hypertension who are treated for six weeks. Secondary objectives include assessing the effect of ETC-1002 on blood pressure, other lipid and cardiometabolic biomarkers and characterizing the tolerability and safety of ETC-1002.











Also Thursday:












Blue Line Protection Group, Inc. (OTCBB:BLPG) (OTCQB:BLPG)
, the leader in providing state regulatory compliance, financial services and asset protection to the lawful cannabis industry, today announced the Company has entered into an agreement with a recreational marijuana dispensary in the state of Washington to provide its full suite of security and compliance services.



Enzymotec Ltd. (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today announced that it will release financial results for the second quarter ended June 30, 2014 on Tuesday, August 5, 2014, before the market opens.



Flexion Therapeutics, Inc. (Nasdaq:FLXN)
announced today changes to the composition of its Board of Directors. Sandesh (Sandy) Mahatme has been appointed to the Board of Directors, effective July 22, 2014.



Herborium® Group, Inc. (OTC Pink: HBRM)
, a Botanical Therapeutics® Company and the provider of unique all botanical medicinal products that target dermatological problems such as acne, and other health and wellness concerns in the areas of sexual performance as well as energy depletion and stress, reports that its sales for the first seven months of 2014 has surpassed the sales realized in the entire year of 2013.



ID Global Corp. (OTC:IDGC)
is pleased to provide an update pursuant to the execution of the LOI announced on July 23, 2014.



K2M Group Holdings, Inc. (Nasdaq:KTWO)
, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced that the Company intends to release 2014 second quarter financial results after market close on August 6.



Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
announced the publication of results from the long-term, randomized, active control Phase 3 study of Zerenex (ferric citrate), the Company's investigational oral ferric iron-based phosphate binder, for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis.



MacroGenics, Inc. (Nasdaq:MGNX)
, a clinical stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that its investigational new drug (IND) for MGD007 has been cleared by the U.S. Food and Drug Administration (FDA) to proceed with the Phase 1 human clinical trial for this drug candidate.



MYOS Corporation (Nasdaq:MYOS)
, an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve muscle health and performance, announced today that it recently received a Notice of Allowance from the U.S. Patent and Trademark Office ("USPTO") for U.S. Patent Application Serial No. 13/765,340 covering the Company's proprietary methods of manufacturing Fortetropin™, the first clinically proven natural myostatin inhibitor.



Nutra Pharma Corp. (OTCPink:NPHC)
, a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), is announcing that they are in the process of completing critical capital improvements to their warehouse and fulfillment center in order to meet increased demand and shipments of their over-the-counter (OTC) pain reliever, Nyloxin®.



Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
, today announced that the financial results for its fiscal first quarter 2015, ended June 30, 2014, will be released after the U.S. markets close on August 7, 2014.



Pacific Biosciences of California, Inc. (Nasdaq:PACB)
today reported an 89% increase in revenue to $11.4 million for the second quarter, compared to $6.0 million for the second quarter of 2013.



Pazoo, Inc. (OTCQB:PZOO)
(German WKN#: A1J3DK) is pleased to report CEO David Cunic was asked to appear on The Stock Radio for an interview on Pazoo Inc, its current projects, and the future of the company.



Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX)
, announced today that it has chosen Mr. Shlomo Yanai as Chairman of the Company's Board of Directors, effective on July 24, 2014.



REVA Medical, Inc. (ASX:RVA)
announced today that James J. Schiro will step down from the Board, effective immediately, in order to undergo treatment after a diagnosis of multiple myeloma.



The Spectranetics Corporation (Nasdaq:SPNC)
today reported financial results for the three and six months ended June 30, 2014.



TESARO, Inc. (Nasdaq:TSRO)
, an oncology-focused biopharmaceutical company, today announced that Mary Lynne Hedley, Ph.D., President and Co-Founder of TESARO, has been appointed to the role of Chief Operating Officer.



TESARO, Inc. (Nasdaq:TSRO)
, an oncology-focused biopharmaceutical company, today reported financial results for the second quarter of 2014.


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Source: BioMed Reports


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