Arrowhead Begins Phase 1 Trial of ARC-520; Sarepta to Host Conference Call to Discuss Eteplirsen Print E-mail
By Staff and Wire Reports   
Tuesday, 23 July 2013 18:39
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 23, 2013.

Arrowhead Research Corporation (NASDAQ: ARWR)
, a biopharmaceutical company developing targeted RNAi therapeutics, announced it has initiated dosing in a Phase 1 clinical trial of ARC-520, the Company's candidate for the treatment of chronic hepatitis B virus infection. Trial initiation followed successful completion of the Clinical Trial Notification (CTN) regulatory process in Australia. The objectives of the study are to characterize the safety profile of ARC-520, determine maximum tolerated dose, and evaluate pharmacokinetics in healthy volunteers. ARC-520 is the first candidate to use Arrowhead's proprietary Dynamic Polyconjugate (DPC) delivery platform and includes two distinct siRNA sequences that have pan-genotypic coverage for 99.6% HBV GenBank sequences.

The Phase 1 trial is a single-center, randomized, double-blind, placebo-controlled, single dose-escalation, first-in-human study of ARC-520 administered intravenously to healthy adult volunteers and is being conducted in Melbourne, Australia. Each dose cohort includes 6 subjects randomized at ratio of 1:2 (placebo:active) to receive a single intravenous injection of either placebo or ARC-520. Arrowhead expects to complete this Phase 1 trial in the fourth quarter of 2013 and begin a Phase 2a trial in chronic HBV patients in 2014.

“This Phase 1 study will establish a safety profile for ARC-520 as well as provide the first human data for our DPC delivery platform. This is an important step forward as we seek to advance ARC-520 into HBV patients and build additional RNAi therapeutics based on what we believe is the most potent delivery system in the industry,” said Dr. Christopher Anzalone, President and Chief Executive Officer.

Hepatitis B is the world's most common serious liver infection. It is estimated that 350 million people worldwide are chronically infected with HBV, representing approximately 1 in 20 people on the planet. No currently available treatment methods can reliably achieve meaningful cure rates. ARC-520 is designed to reduce the production of new viral particles and viral proteins. Many experts believe that reducing key viral proteins can revive patients' adaptive immune response and potentially lead to a functional cure of chronic HBV infection with a finite treatment regimen. Arrowhead previously presented data generated in rodent models and in a chimpanzee chronically infected with HBV, showing that ARC-520 induces rapid, deep, and durable knockdown of both circulating HBV DNA and key viral proteins, including hepatitis B s-antigen, e-antigen, and the core protein that forms the capsid.



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Sarepta Therapeutics (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, announced it will hold a conference call at 8:00 a.m. EDT (5:00 a.m. PDT) on Wednesday, July 24, 2013, to provide a regulatory update for eteplirsen, its lead product candidate for the treatment of Duchenne muscular dystrophy (DMD).

The conference call may be accessed by dialing 800.446.2782 for domestic callers and 847.413.3235 for international callers. The passcode for the call is 35357086. Please specify to the operator that you would like to join the "Sarepta Therapeutics Regulatory Update Call." The conference call will be webcast live under the events section of Sarepta's website at www.sarepta.com and will be archived there following the call for 90 days. Please connect to Sarepta's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

Also Tuesday:

The Alkaline Water Company Inc. (OTCBB: WTER), developers of an innovative, state of the art, proprietary electrolysis process that creates healthy alkaline water for a balanced lifestyle, is pleased to announce the successful launch of its flagship product, Alkaline84, into the Southern California marketplace.

Arch Therapeutics, Inc.(OTCQB: ARTH)
, a life science company and developer of AC5™, a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to advise that co-founding and inventing scientist, Dr. Rutledge Ellis-Behnke, delivered a lecture titled "The Spider Effect, how the Immune System in the Brain can be Measured and Modulated with Nanotechnology" at the 6th annual European Foundation for Clinical Nanomedicine (CLINAM) Summit in Basel, Switzerland.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers and a pioneer in laser surgery in other medical specialties, announced today that medical device marketing executive and eye care, medical laser, and post-surgical anesthesia industry veteran Orlando P. Rodrigues has been named Vice President, Marketing.

Cepheid (Nasdaq: CPHD)
and the American Lung Association (www.Lung.org) today announced a partnership to promote tuberculosis-related awareness in the U.S. and the need for improved TB (tuberculosis) diagnostics.

Graymark Healthcare Inc. (OTCQB: GRMH)
, a leading provider of care management solutions to the sleep disorder market, announced today that it has completed the acquisition of Foundation Surgical Hospital Affiliates LLC and Foundation Surgery Affiliates LLC (collectively "Foundation").

iSatori, Inc. (OTCQB: IFIT)
, an emerging leader in the development and marketing of scientifically engineered nutritional supplements for healthier lifestyles, is pleased to announce that Curvelle, its branded weight-loss supplement especially designed for women, has been nominated as "Women's Product of the Year" by the premier internet retailer Bodybulding.com's Supplement Awards program.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)
, a biopharmaceutical company focused on discovering breakthrough treatments for human disease, will release its second quarter 2013 financial results on Tuesday, July 30, 2013 before the financial markets open.

LipoScience, Inc. (Nasdaq:LPDX)
today announced that it will release its second quarter of fiscal year 2013 financial results before the market open on Tuesday, August 6, 2013.

Masimo (NASDAQ: MASI)
announced today that it has entered a new year-to-year group purchasing agreement with Community Health Ventures (CHV), the business development affiliate of the National Association of Community Health Centers (NACHC), representing more than 9,000 health centers nationwide.

Net Medical Xpress Solutions, Inc. (OTCQB: NMXS)
, a leader in the telemedicine market, announced today that the University of New Mexico has agreed to provide expanded neuro-specialist and neuro-surgery coverage in New Mexico using Net Medical's emerging technology.

Nova Mining Corporation (OTCBB: NVMN) entered into an Asset Purchase Agreement with The Renewable Corporation, a Washington corporation and its wholly owned subsidiary Renewable Bioscience Technologies, Inc., a Florida corporation to purchase their license, certain assets and processes to innovative technologies in skin protection from the sun, industrial UV sources (such as welding), and reducing collateral damage from medical radiation treatment which consists of various patented skin products under the "Radiant Creations" label.

Goldman Small Cap Research, a stock market research firm focused on the small cap and microcap sectors, released a research update on Plandai Biotechnology Inc.'s (OTCQB: PLPL).

Swisher Hygiene Inc. (Nasdaq:SWSH) (TSX:SWI)
, a leading provider of essential hygiene and sanitizing products and services, announced today that on July 17, 2013, it received a written notice (the "Notice") from the Listing Qualifications department of The Nasdaq Stock Market ("Nasdaq") indicating that Swisher is not in compliance with the minimum bid price requirement of $1.00 per share set forth in Nasdaq Listing Rule 5450(a)(1) for continued listing on The Nasdaq Global Select Market.

Techne Corporation (NASDAQ: TECH)
announced today that J. Fernando Bazan, Ph.D. has been appointed Chief Technology Officer.

Vascular Solutions, Inc. (Nasdaq:VASC)
today reported financial results for the second quarter ended June 30, 2013.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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