|Arrowhead Files to Begin Phase 1 Trial of RNAi Therapeutic; Covidien Nellcor™ Pulse Oximeters Receive FDA 510(k) Clearance|
|By Staff and Wire Reports|
|Tuesday, 28 May 2013 19:34|
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.
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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.