Arrowhead Files to Begin Phase 1 Trial of RNAi Therapeutic; Covidien Nellcor™ Pulse Oximeters Receive FDA 510(k) Clearance Print E-mail
By Staff and Wire Reports   
Tuesday, 28 May 2013 19:34
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 28, 2013.

Arrowhead Research Corporation (NASDAQ: ARWR)
, a targeted therapeutics company, announced it recently filed an application for approval to begin a phase 1 clinical trial of its RNAi-based therapeutic candidate, ARC-520, against chronic hepatitis B virus infection. Pending approval, Arrowhead intends to proceed with a phase 1, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal adult volunteers.

The application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration.

“We are pleased to meet our stated goal of a regulatory submission during the second quarter. This represents an important milestone for Arrowhead as we move our HBV candidate, ARC-520, and the DPC siRNA delivery system towards first-in-man studies,” said Dr. Christopher Anzalone, President and Chief Executive Officer.

About ARC-520 -- Hepatitis B virus is the world's most common serious liver infection, with an estimated 350 million patients worldwide that are chronically infected. There are thought to be approximately 2 million patients in the U.S., 14 million in Western Europe, over 100 million in the Asia Pacific Region, and another 220+ million throughout the rest of the world. HBV can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally. The annual death toll for HBV is estimated as high as one million. Arrowhead's RNAi-based candidate ARC-520 has the potential to treat chronic hepatitis B virus infection in a fundamentally different manner than current therapies. The goal is to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. The siRNAs in ARC-520 intervene at the point of DNA transcription, upstream of where nucleotide and nucleoside analogues act, and can deeply knockdown all HBV gene products, including proteins and the viral intermediates necessary to produce viral DNA. In transient and transgenic mouse models of HBV infection, a single co-injection of the DPC delivery vehicle with cholesterol-conjugated siRNA targeting HBV sequences resulted in multi-log knockdown of HBV RNA, proteins and viral DNA with long duration of effect. Arrowhead is on track to conduct a phase 1 single ascending dose study in normal volunteers in mid-2013, which the company expects will be followed by a phase 2a study in chronic HBV patients in Hong Kong.


Every year, nearly 7,200 infants are born in the United States with a Critical Congenital Heart Disease (CCHD). 1 It is a condition that is often easily detectable and, when discovered, quite treatable.

Far too frequently, however – in nearly one case in three – newborns with CCHD leave the hospital undiagnosed. Generally asymptomatic until it's too late, they go home to face the possibility of long-term disability or sudden death. Each year, 100 to 200 newborns fall victim to CCHD.2

Covidien (NYSE:COV)
, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, is addressing this situation.

The company's Nellcor pulse oximetry portfolio facilitates quick, noninvasive screenings for CCHD. The products are U.S. Food and Drug Administration (FDA)-510(k) cleared for use on neonates, so physicians can rely on them for accurate CCHD screenings. Now – as part of a broad effort to educate clinicians on the importance of CCHD screenings and encourage hospitals to implement routine CCHD screening for all newborns – Covidien has begun labeling and promoting the use of Nellcor pulse oximetry as a tool to aid healthcare practitioners in CCHD screening.

“CCHD is a life-threatening condition that can be detected and treated earlier through proper screening,” said Matthew Anderson, Vice President and General Manager, Respiratory and Monitoring Solutions, Covidien. “Covidien is committed to raising public awareness about this issue and encouraging CCHD screenings. We truly hope our CCHD resources, the educational support we offer clinicians and our pulse oximetry portfolio help make an important difference in the fight against CCHD.”

Covidien's CCHD awareness activities ensure clinicians understand how to use pulse oximeters and best generate reliable readings. Covidien offers free CCHD educational resources through its new Professional Affairs and Clinical Education (PACE) Online Platform.

Highly Accurate CCHD Screenings -- Covidien's new CCHD labeling was introduced as part of the FDA 510(k)-cleared labeling for motion tolerant Nellcor pulse oximeters. In 2011, the U.S. Department of Health and Human Services added CCHD screening to the Federal Recommended Uniform Screening Panel Guidelines. As a follow up to those guidelines, the Consensus Work Group's recommendation specified the use of pulse oximeter devices that are motion tolerant, report functional oxygen saturation, have been validated in low perfusion conditions, and have been cleared by the FDA for use in newborns. The performance of Nellcor pulse oximeters demonstrates that the criteria are fully met and the devices provide accurate readings even during patient movement. This can be particularly important for CCHD screenings in newborns because their tendency to move can prevent accurate readings.

Also Tuesday:

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first in-class collagenase-based products marketed as XIAFLEX® in the U.S., today announced that BioSpecifics' President, Tom Wegman, will present a corporate overview at the upcoming Jefferies 2013 Global Healthcare Conference at 10:00 a.m. EDT on Monday, June 3, 2013 in New York, NY.

Cempra, Inc. (Nasdaq: CEMP)
, a clinical-stage pharmaceutical company focused on developing differentiated antibiotics, today announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded Cempra with a five year contract valued up to $58 million for the development of solithromycin to treat infections in pediatric populations and for the treatment of infections by bioterror threat pathogens.

Gilead Sciences, Inc. (Nasdaq: GILD)
today announced that the European Commission has granted marketing authorization for Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg), a single tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.

Luminex Corporation (NASDAQ: LMNX)
today announced it has extended their global supply and distribution agreement with EMD Millipore—the Life Science division of Merck KGaA, Darmstadt, Germany.

MiMedx Group, Inc. (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it will present at the Jefferies 2013 Global Healthcare Conference in New York.  

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP)
, a developer of oral drug delivery systems, announced today that the company's CEO, Nadav Kidron, has been invited to be a speaker at two key events in New York and Los Angeles.

Plandaí Biotechnology, Inc.'s (OTCQB: PLPL)
Phytofare™ brand will feature three botanical extracts with a much higher bioavailability than the current market offers.

PLC Systems Inc. (OTCQB: PLCSF)
, a company focused on innovative medical device technologies, today announced that Dr. Vaikom Mahadevan presented RenalGuard® data during the Interventions for Structure Heart Disease session at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Pressure BioSciences, Inc. (OTCQB: PBIO)
announced that Mr. Richard T. Schumacher, President and CEO, will present a corporate overview and business update at the 2nd Annual Marcum MicroCap Conference on Thursday, May 30th, at 4:00 pm EDT.  

Profit Planners Management, Inc. (OTCQB: PPMT)
CEO and founder has been interviewed by SNNLive™ On Location with

Rosetta Genomics Ltd. (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, announces that the Company will have a significant presence at the upcoming American Society of Clinical Oncologists Annual Meeting (ASCO 2013) taking place at the McCormick Convention Center in Chicago from May 31-June 4, 2013.

SK3 Group, Inc. (OTC Pink: SKTO)
today announces that it will be distributing 100 million common shares of Alternative Energy Partners, Inc (OTCBB: AEGY) to its shareholders of record at the close of business on the date of filing of a registration statement to register the shares to be distributed.
StellarBiotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH)
today announced the presentation of a poster at the Annual 2013 National Science Foundation (NSF) Conference in Baltimore, MD highlighting the Company's achievements in developing methods related to the sustainable cultivation of the ocean mollusk that is the sole source for Keyhole Limpet Hemocyanin (KLH).

Synergetics USA, Inc. (NASDAQ: SURG)
announced today that it will host a conference call on Monday, June 10, 2013 at 4:00 p.m. Central Time (5:00 p.m. Eastern) to review the Company's results for the fiscal third quarter ended April 30, 2013.
On May 24, 2013, a class action lawsuit was filed in the United States District Court for the Northern District of Ohio against Invacare Corporation (NYSE: IVC).

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (the "Company" or "Verisante"), a leader in cancer imaging technology, wishes to confirm that is it unaware of any material change in the Company's operations that would account for the recent market activity.

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