Omeros Announces Positive OMS721 Data; Keryx Announces Zerenex(TM) Meets All Primary and Key Secondary Endpoints in Phase 2 Print
By Staff and Wire Reports   
Tuesday, 05 November 2013 20:26
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 5, 2013.

Omeros Corporation (NASDAQ: OMER)
announced positive data using OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program, in a well-established animal model of neovascular age-related macular degeneration (AMD), which is characterized by abnormal growth of new blood vessels behind the retina of the eye and is a leading cause of vision loss in individuals over 60 years of age. Omeros is currently completing a Phase 1 clinical trial of OMS721 in healthy subjects.

The study was conducted by Dr. Puran S. Bora and colleagues at the Jones Eye Institute, Pat and Willard Walker Eye Research Center of the University of Arkansas for Medical Sciences. In this animal model, new vessel growth in the eye is induced by laser treatment. Systemically administered OMS721 resulted in less than half of the blood vessel development compared to placebo treatment. The study included an antibody to vascular endothelial growth factor (VEGF) that also reduced blood vessel growth, and OMS721 outperformed the anti-VEGF treatment. Anti-VEGF treatment is the current mainstay of commercially available therapies for neovascular AMD.

Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein involved in activation of the complement system – an important component of the immune system. The complement system plays a role in the inflammatory response to tissue damage or microbial infection, and both human genetic and animal studies have linked the complement system to AMD development. OMS721 selectively inhibits MASP-2, blocking the lectin pathway of the complement system while leaving intact the classical pathway, or the acquired immune response to infection. Omeros recently reported preclinical findings indicating that blockade of MASP-2 by OMS721 may also have a preventive or therapeutic effect in the treatment of thrombotic microangiopathy (TMA), a disorder that occurs in the microcirculation (e.g., venules and capillaries) of the body's organs, most commonly the kidney and brain.

In July of this year, Omeros began enrollment in its Phase 1 clinical program evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 administered intravenously and subcutaneously in healthy subjects. A Phase 2 clinical trial in patients suffering from TMAs, including atypical hemolytic uremia syndrome, is planned to begin enrollment in early 2014.

"The data from this study directly evaluating the activity of OMS721, our lead MASP-2 inhibitor currently in a Phase 1 clinical program, further support its potential effects in the treatment of a wide range of complement-related diseases in humans," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We look forward to reporting the results of our Phase 1 clinical trial and the initiation of enrollment in our Phase 2 program."



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Keryx Biopharmaceuticals (Nasdaq: KERX)
announced successful top-line results from its Phase 2 study of Zerenex™ (ferric citrate coordination complex) in non-dialysis dependent chronic kidney disease (NDD-CKD) patients with elevated serum phosphorus and iron deficiency anemia. In this study, Zerenex met both co-primary endpoints, described below, demonstrating highly statistically significant changes in serum phosphorus and transferrin saturation (TSAT) versus placebo over the 12-week treatment period. In addition, Zerenex met the key secondary endpoints of increasing ferritin and hemoglobin, and decreasing fibroblast growth factor-23 (FGF-23) versus placebo. The Company plans to meet with the Food and Drug Administration (FDA) to discuss these data with the goal of defining a path forward towards obtaining a labeled indication for the treatment of iron deficiency anemia in NDD-CKD patients.

The Co-Chairmen of the study were Geoffrey A. Block, MD, Director of Clinical Research at Denver Nephrology; Glenn Chertow, MD, Chief, Division of Nephrology and Professor of Medicine at Stanford University School of Medicine; and Steven Fishbane, MD, Chief, Division of Nephrology, Vice President of North Shore-LIJ Health System for Network Dialysis Services and Director of Clinical Research at North Shore-LIJ Department of Medicine.

Study Design:  This Phase 2 study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with stage 3 to 5 NDD-CKD, with elevated serum phosphorus ≥4.0 mg/dL and iron deficiency anemia. The study consisted of a 2-week washout period (for subjects on a phosphate binder at screening) followed by a 12-week treatment period in which subjects were randomized 1:1 to receive either Zerenex or placebo. One hundred forty-nine (149) subjects were randomized into the study from 20 sites in the United States.

The use of intravenous (IV) iron and erythropoiesis-stimulating agents (ESAs) were not permitted within 8 weeks and 4 weeks prior to the study, respectively, and not permitted during the course of the study. Oral iron therapy was also not permitted during the course of the study.



Also Tuesday:



Abiomed, Inc. (Nasdaq:ABMD)
, a leading provider of breakthrough heart support technologies, today announced that Robert L. Bowen, Vice President and Chief Financial Officer, and Susan V. Lisa, Senior Director, Investor Relations and Corporate Development, will present at the Stephens Fall Investment Conference, November 12, 2013 at 4:00 p.m. ET.

Acasti Pharma (Nasdaq:ACST) (TSX-V:APO)
, a subsidiary of Neptune Technologies & Bioressources Inc., announces the appointment of Reed V. Tuckson, M.D. to its Board of Directors.

ADC Therapeutics Sarl, a portfolio company of Auven Therapeutics and the oncology drug development company specializing in proprietary antibody drug conjugates, and Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced an exclusive license agreement for human antibodies directed to an undisclosed target expressed on the surface of various types of cancers.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
, a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology, today reported financial and operating results as at and for the three months ended September 30, 2013.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today that it has successfully enrolled the 36th and final patient in a placebo-controlled Phase II clinical study designed to compare the efficacy of varied dosage levels of MG01CI to treat and improve cognitive dysfunctions in adult subjects with Predominantly Inattentive Attention Deficit/Hyperactivity Disorder (PI-ADHD).

Apricus Biosciences, Inc. (Nasdaq:APRI)
announced today that it will hold a conference call to discuss its recent corporate highlights on Wednesday, November 13, 2013 at 9:00 AM ET.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
today announced that Jean-Jacques Bienaimé, Chief Executive Officer at BioMarin, will present a company update at the Credit Suisse 2013 Healthcare Conference on Tuesday, November 12, 2013 at 9:30 a.m. MST.

BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, today reported results for the third quarter ended September 30, 2013.

Bottomline Technologies (Nasdaq:EPAY)
today announced the opening of its second annual Healthcare Customer Insights Exchange (CIE) in Del Mar, California.

Cellular Dynamics International (Nasdaq:ICEL)
today announced that it will report third quarter 2013 financial and operating results after the close of U.S. financial markets on November 12, 2013.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP)
today reported financial results for the third quarter ended September 30, 2013.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today that it will report financial results for the third quarter ended September 30, 2013, on Thursday, November 14, 2013, before the market opens.

China Biologic Products, Inc. (NASDAQ: CBPO)
, a leading fully integrated plasma-based biopharmaceutical company in China, today announced its unaudited financial results for the third quarter of 2013.

Compuware Corporation (Nasdaq: CPWR)
, the technology performance company, announced today that Houston-based Encore Health Resources, LLC, one of the most successful consulting firms in the health information technology (HIT) industry, has selected Changepoint as one of three core business applications supporting Encore's rapidly growing healthcare IT consulting practice.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, today announced that the US Patent and Trademark Office (USPTO) issued two patents extending the exclusivity of sapacitabine, the Company's lead clinical candidate.

Durata Therapeutics (Nasdaq:DRTX)
announced today that Paul R. Edick, CEO, will present an overview of the Company at the Credit Suisse Healthcare Conference on Tuesday, November 12, 2013 at 4:00 PM MT in Scottsdale, Arizona.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, announced today that Shelley Thunen, Chief Financial Officer, is scheduled to present at the Stephens Fall Investment Conference in New York.

Given Imaging Ltd. (Nasdaq:GIVN)
today announced financial results for the third quarter ended September 30, 2013.

Health Insurance Innovations, Inc. (Nasdaq:HIIQ)
, a leading developer and administrator of affordable, cloud-based individual health insurance plans and ancillary products, announced today that it will report third quarter 2013 financial results on Monday, November 11, 2013.

Hologic, Inc. (NASDAQ: HOLX),
a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, announced today that two leading healthcare organizations recently recognized 3D mammography (breast tomosynthesis) technology with important industry awards.  

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced the issuance of U.S. patent no. 8,574,575 for "RS7 Antibodies."

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
today announced successful top-line results from its Phase 2 study of Zerenex™ (ferric citrate coordination complex) in non-dialysis dependent chronic kidney disease (NDD-CKD) patients with elevated serum phosphorus and iron deficiency anemia.

Kelyniam Global Inc. (OTC: KLYG)
has successfully resolved the lawsuit with former employee John Mastoloni.  Per terms of the settlement agreement, details are confidential.  

Life Technologies Corporation (NASDAQ: LIFE)
today announced results for its third quarter ended September 30, 2013.  

LipoScience, Inc. (Nasdaq:LPDX)
, a diagnostic company pioneering a new field of personalized nuclear magnetic resonance (NMR) diagnostics to advance the quality of patient care in cardiovascular, metabolic and other diseases, today announced its financial results for the third quarter ended September 30, 2013.

MacroGenics, Inc. (Nasdaq:MGNX)
today announced that on Tuesday, November 12, 2013, the Company will release its financial results for the third quarter ended September 30, 2013.

MAKO Surgical Corp. (Nasdaq:MAKO)
, a medical device company that markets its RIO® Robotic Arm Interactive Orthopedic surgical platform, MAKOplasty® joint specific applications and proprietary RESTORIS® implants that together enable orthopedic surgeons to consistently, reproducibly and precisely treat patient specific osteoarthritic disease, today announced its operating results for the quarter ended September 30, 2013.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
today announced that the company will host its Third Quarter 2013 Investor Conference call at 8 a.m. Eastern time on Thursday, November 7.

MRI Interventions, Inc. (OTCQB:MRIC)
, a commercial stage medical technology company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart, announced today that Kimble Jenkins, MRI Interventions' Chief Executive Officer, will present at the Canaccord Genuity Medical Technology & Diagnostics Forum in New York on Thursday, November 14, 2013.

Mesa Laboratories, Inc. (NASDAQ: MLAB)
today reported an eight percent increase in revenues for the second quarter ended September 30, 2013.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced financial results for its fiscal first quarter ended Sept. 30, 2013.

National Research Corporation (NASDAQ:NRCIA and NRCIB)
today announced results for the third quarter of 2013.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
announces the appointment of Reed V. Tuckson, M.D. to its Board of Directors.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
, today announced that the financial results for its fiscal second quarter 2014, ended September 30, 2013, will be released after the U.S. market closes on November 19, 2013.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced today that it has earned a $15 million milestone payment from Bayer Pharma AG related to achieving a dose escalation milestone in the Phase 1a clinical trial of OMP-54F28 (Fzd8-Fc). OMP-54F28 is an antagonist of the Wnt pathway, a key cancer stem cell pathway.

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
, a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that financial results for the Company's third quarter ended September 30, 2013 will be released on Tuesday, November 12, 2013.

Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT)
is developing medical products that efficiently deliver oxygen to tissues in the body.

Premier, Inc. (Nasdaq:PINC)
President & CEO, Susan DeVore, will ring The NASDAQ Stock Market Opening Bell remotely from Charlotte, North Carolina. Premier, Inc. is a leading healthcare improvement company, uniting more than 2,900 U.S. hospitals and nearly 100,000 other providers to transform healthcare.

Portola Pharmaceuticals, Inc. (Nasdaq:PTLA)
today will provide a corporate update and report its financial results for the third quarter ended September 30, 2013.

RCM Technologies, Inc. (Nasdaq:RCMT)
, a premier provider of business and technology solutions designed to enhance and maximize the operational performance of its customers through the adaptation and deployment of advanced information technology, engineering and specialty healthcare services, today announced that its Lead Independent Director, Robert B. Kerr, has responded, on behalf of all of RCM's independent directors, to a letter they received from Bradley S. Vizi of Legion Partners Asset Management, LLC, on Friday, November 1, 2013.

Regado Biosciences, Inc. (Nasdaq: RGDO)
, a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced the appointment of Michael E. Mendelsohn, M.D., to the company's Board of Directors.  

Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported financial results for the third quarter of 2013.

StemCells, Inc. (Nasdaq:STEM)
, a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today reported financial results for the third quarter ended September 30, 2013 and provided a business update.

Surgical Care Affiliates, Inc. (Nasdaq:SCAI)
today announced that it will release its third quarter 2013 financial results on Wednesday, November 13, 2013, after the market closes.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS)
today announced that it will host a conference call on Tuesday, November 12, 2013 at 11:00 a.m. Eastern Time to discuss corporate updates and financial results for the third quarter ended September 30, 2013.

The Medicines Company (NASDAQ: MDCO)
is scheduled to present at the Credit Suisse Healthcare Conference in Arizona on Tuesday, November 12th at 3:30 PM Mountain Time (5:30 PM Eastern Time).

Tornier N.V. (Nasdaq:TRNX)
, a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, reported today its financial results for the third quarter ended September 29, 2013.

VIVUS, Inc. (Nasdaq:VVUS)
, a biopharmaceutical company commercializing Qsymia® (phentermine and topiramate extended-release) capsules CIV for the treatment of obesity, today provided a business update and reported its financial results for the third quarter and nine months ended September 30, 2013.

ZELTIQ®, (Nasdaq:ZLTQ)
a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, announced today the commencement of an underwritten public offering of 4,500,000 shares of its common stock, all of which are being offered by selling stockholders.



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