|Novavax Begins Enrollment of Phase 1 Clinical Trial of RSV Vaccine; Delcath Says FDA Designated NDA for Standard Review|
|By Staff and Wire Reports|
|Monday, 15 October 2012 18:30|
Novavax, Inc. (Nasdaq: NVAX) announced enrollment has begun in a Phase 1 dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adults 60 years of age and older.
This randomized, blinded, placebo-controlled Phase 1 study will evaluate the immunogenicity and safety of two doses of Novavax' RSV-F nanoparticle protein micelle vaccine candidate with and without aluminum phosphate as an adjuvant. The study is similar to the recently launched Phase 2 RSV study in women of childbearing age but will enroll 220 adults 60 years of age and older who will receive a single intramuscular injection of Novavax' RSV-F nanoparticle protein micelle vaccine or placebo plus a single dose of licensed influenza vaccine or placebo at days 0 and 28. Safety and immunogenicity will be evaluated for up to one year.
Delcath Systems, Inc. (NASDAQ: DCTH) announced the U.S. FDA has accepted the Company's New Drug Application (NDA) for its proprietary chemosaturation system with melphalan hydrochloride for injection. The FDA has designated the NDA for standard review. Delcath expects to be notified of its PDUFA date in the FDA's 74-Day letter, which the Company expects to receive by the end of October. Under the Prescription Drug User Fee Act (PDUFA), the FDA has the goal of completing its review of applications designated for standard review within 10 months of the NDA submission, which was submitted on August 15, 2012.
The Company is seeking approval for its proprietary chemosaturation system with melphalan hydrochloride as a treatment for patients with unresectable metastatic melanoma in the liver.
Abbott (NYSE: ABT) today announced initial results from "Aviator," a phase 2b study of its interferon-free, investigational regimen for the treatment of hepatitis C (HCV). Initial results show sustained virological response at 12 weeks post treatment (SVR12) in 99 percent of treatment-naive (n=77) and 93 percent of null responders (n=41) for genotype 1 (GT1) HCV patients taking a combination of ABT-450/r, ABT-267, ABT-333 and ribavirin for 12 weeks, based on an observed data analysis.
Amarantus BioSciences, Inc. (OTCQB: AMBS), today announced that it has retained the legal services of JS Barkats, PLLC ("JS Barkats") to represent the Company as its corporate and securities counsel.
Biomerica, Inc. (OTCBB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, announced financial results today for the first fiscal quarter ended August 31, 2012.
CDEX Inc. (OTCQB: CEXID), a leading developer of chemical detection products using patented technologies for use in healthcare, safety and security markets, today announced the completion of its financial restructuring emerging with no debt and working capital for growth.
Element Trading Technologies Inc. (PINKSHEETS: UTRM), a company which trains market traders to successfully trade stocks with the company's proprietary trading account, announced today that the company will be conducting its first free one hour Webinar today, October 15 at 4:30 PM for stock traders.
Grant Walsh, Chairman of Medifocus, Inc. (OTCQX: MDFZF) and (TSX VENTURE: MFS), which originated and is currently marketing the FDA-approved Prolieve® System in addition to the developing the APA-1000 that uses focused and controlled microwave energy to shrink or eradicate cancerous tumors with minimal invasion, has been interviewed on the Stock Legends Radio Show.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the closing of the sale of its women's health business to Meda (an international specialty pharmaceutical company) for $95 million in cash.
Masimo (NASDAQ: MASI) announced today limited market release of the Universal ReSposable™ Pulse Oximetry Sensor System, offering the Measure-Through Motion and Low Perfusion performance and accuracy of SET®, as well as the comfort of its single-patient-use adhesive sensors with the cost-effectiveness and environmental advantages of a reusable sensor.
Mauna Kea Technologies (NYSE Euronext: MKEA), a leader in the field of optical biopsy, today announced its sales for the third quarter and first nine months of the year ended September 30, 2012.
MediSwipe Inc. (OTCQB: MWIP), a merchant payment solutions and financial products company for the medical health care industry, today announced that its Board of Directors has authorized the Company to file the S-1 registration statement of its 800 Commerce for the benefit of its shareholders.
Neuralstem, Inc. (NYSE MKT: CUR) announced that data on Neuralstem's NSI-566 spinal cord-derived neural stem cell line in a rat model of ischemic stroke was presented in a poster, "Histopathological Assessment of Adult Ischemic Rat Brains after 4 Weeks of Intracerebral Transplantation of NSI-566RSC Cell Line," at The Society for Neurosciences Annual Meeting (http://www.sfn.org/AM2012/).
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced that the company completed enrollment in the FOCUS trial, an international Phase 3 clinical trial evaluating single-agent carfilzomib in patients with relapsed and refractory myeloma who have received three or more prior therapies.
SpectraScience, Inc. (OTCQB: SCIE), a San Diego-based medical device company, announced that its WavSTAT Optical Biopsy System will be featured in the PENTAX Medical booth at the United European Gastroenterology Week Conference (UEGW) in Amsterdam, October 20-25, 2012.
SunSi Energies Inc. ("SunSi") (OTCQB: SSIED) (OTCQB: SSIE), an international manufacturer, seller and distributor of energy products and solutions, today announced it has entered into an agreement with Gold Rush Gaming Room, LLC ("Gold Rush Gaming") to conduct a trial of its LED lighting products at Gold Rush Gaming's 15,000 square foot facility located in Collin County, Texas.
Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that its successful Phase 2 clinical trial evaluating an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women was the subject of an oral presentation given by Morten Karsdal, MSc, PhD, Chief Executive Officer of Nordic Bioscience, at the ASBMR 2012 Annual Meeting in Minneapolis, MN.