Nasdaq GlobeNewswire

Novavax Initiates Phase 1/2 Trial of NanoFlu(TM) Vaccine in Older Adults

Del
  • Recently published NanoFlu(TM) preclinical data provide strong rationale for Phase 1/2 clinical trial based on robust antibody titers and improved protective responses against both current and drifted strains
  • Data from trial expected by the end of 2017

GAITHERSBURG, Md., Sept. 19, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced the enrollment of the first participant in a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate including its proprietary Matrix-M(TM) adjuvant (NanoFlu(TM)) in older adults.

The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).

"The trial is designed to identify an immune response, characterized by hemagglutination-inhibiting (HAI) and neutralizing antibodies, that is similar to or better than Fluzone HD," said Gregory Glenn, M.D., President of Research and Development. "We will evaluate immunogenicity using HAI titers, which are the industry standard and an established surrogate marker of protection. Data from this trial may provide the basis to request accelerated approval for initial licensure of our NanoFlu vaccine.

"Our recent preclinical data further indicate NanoFlu elicits improved protective responses against drifted strains, which could be a key differentiating factor of the vaccine. Current influenza vaccine protection is typically limited to strain-specific immune responses. Strain mismatch or antigenic drift between seasonal vaccines and circulating influenza strains can lead to reduced protection."

"The data described in our recent Vaccine publication provided strong rationale for advancing our NanoFlu program into the clinic," said Stanley C. Erck, President and CEO. "Seasonal influenza remains a significant threat to older adults, with nearly three million infections and over 250,000 hospitalizations annually1. Our goal is to deliver a differentiated flu vaccine to the greater than $3 billion global seasonal influenza commercial market2 and we look forward to delivering clinical data from this trial by the end of the year."

About Accelerated Approval

Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments.

Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit. More information on accelerated approval can be found here: https://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm074794.htm

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company's website, novavax.com.

References
1. Average of 3 past seasons, 2010-2013; includes vaccine averted cases. C. Reed et al. Estimating Influenza Disease Burden from Population-Based Surveillance Data in the United States. PLOS One. 2015, DOI:10.1371/journal.pone.0118369

2. PharmaPoint Seasonal Influenza Vaccines Global Drug Forecast and Market Analysis to 2025, October 2016

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2016 and the Report on Form 10-Q for the period ended June 30, 2017, both as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contact:         

Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Director, Investor & Media Relations
ir@novavax.com
240-268-2000
               
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Russo Partners, LLC
David Schull
Maggie Beller
david.schull@russopartnersllc.com 
maggie.beller@russopartnersllc.com
212-845-4271  




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via Globenewswire

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Atico Reports Consolidated Financial Results for the First Quarter of 201824.5.2018 22:30Pressemelding

(All amounts expressed in US dollars, unless otherwise stated) VANCOUVER, British Columbia, May 24, 2018 (GLOBE NEWSWIRE) -- Atico Mining Corporation (the "Company" or "Atico") (TSX.V:ATY) (OTC:ATCMF) today announced its financial results for the three months ended March 31, 2018, posting a net income of $0.4 million. Fernando E. Ganoza, CEO and Director, commented, "The strong production and all-in sustaining cash cost of $1.85 achieved this quarter is not reflected in the financial results as a large concentrate shipment was delayed to the second quarter, along with the revenue associated with those tonnes. The shipping schedule is expected to stabilize during the second quarter, where we will then benefit from the additional shipped concentrate and recognized revenue. We anticipate strong financial results in the next quarter." Mr. Ganoza continued, "Our emphasis will continue to be on further strengthening our balance sheet, improving production costs and most importantly regional

Luxembourg Announced as SNOMED International's Newest Member24.5.2018 15:16Pressemelding

London, United Kingdom, May 24, 2018 (GLOBE NEWSWIRE) -- SNOMED International and Agence eSanté Luxembourg are pleased to announce that Luxembourg has joined the organization as its thirty-second Member. Luxembourg, one of the leading nations in the area of information and communication technology, has set the development of eHealth technologies as a high priority. Agence eSanté, Luxembourg's national agency for the exchange and sharing of medical data, has set an overall mission to facilitate clinical information exchange both within Luxembourg and across other international actors. To work towards this reality, the agency has taken part in discussions about standardization across Europe, a contributing building block achieved with its membership in SNOMED International. With their membership, Agence eSanté has committed their support for the use of structured clinical terminology. When applied to the health sector, interoperability ensures that information systems, and through them h

SEMAFO Signs Underground Mining Services Contract with AUMS24.5.2018 14:00Pressemelding

MONTREAL, May 24, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) reports that it has signed a mining services contract with African Underground Mining Services ("AUMS") to provide turnkey mining services for Siou underground. AUMS is a well-known and reputable mining contractor with underground experience in Burkina Faso and across Africa. Under the mining services contract, AUMS will be responsible for supplying the mining fleet and a skilled labour force for Siou underground in addition to ensuring development, production and auxiliary services. SEMAFO will provide technical services including geology and engineering as well as leveraging the existing surface infrastructure at Mana. The mining services contract has a term of 70 months. The economic terms of the mining services contract are consistent with the economics presented in the Mana pre-feasibility study filed March 29, 2018 on SEDAR. Preparatory work has already commenced on Siou underground with full project deplo

Merus Announces First Patient Dosed in Phase 1 Clinical Trial of MCLA-158 in Patients with Solid Tumors24.5.2018 13:00Pressemelding

- IND Accepted in April by the U.S. FDA for MCLA-158 - UTRECHT, The Netherlands, May 24, 2018 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States. MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal grow

PRA Named International Clinical Research Company of the Year24.5.2018 10:00Pressemelding

RALEIGH, N.C., May 24, 2018 (GLOBE NEWSWIRE) -- PRA Health Sciences, Inc. (NASDAQ:PRAH) is pleased to announce it was recognized by PharmaTimes as the International Clinical Research Company of the Year. This is the fifth year in a row that PRA has received this award. "This award celebrates excellence in the clinical research industry and we are honored to once again be recognized by our peers," said Colin Shannon, President and Chief Executive Officer. "This award is possible thanks to the incredibly talented PRA team members we have working around the world who are deeply committed to their work in bringing new and life-saving therapies to the patients who need them." PRA also swept the Clinical Research Associate and Clinical Trial Administrator categories capturing a total of 11 awards. These awards follow PRA's recognition earlier this month in the PharmaTimes Americas competition where PRA also received 11 awards, including Company of the Year. The PharmaTimes, International Cli

Early Warning Report23.5.2018 20:05Pressemelding

VANCOUVER, British Columbia, May 23, 2018 (GLOBE NEWSWIRE) -- Fortuna Silver Mines Inc. (NYSE:FSM) (TSX:FVI) announces that pursuant to a warrant exercise, it has acquired for a purchase price of C$803,571, direct ownership of 5,357,142 common shares (the "Shares") of Prospero Silver Corp. ("Prospero"), of 510 West Georgia Street, Suite 1800, Vancouver, BC V6B 0M3, at a price of C$0.15 per Share. Immediately following this transaction, Fortuna owned 10,714,284 common shares of Prospero, representing 22.74% of the issued and outstanding common shares of Prospero. Immediately prior to the transaction, Fortuna owned 5,357,142 common shares and 5,357,142 common share purchase warrants. The Shares were acquired by Fortuna for investment purposes, and depending on market and other conditions, it may from time to time in the future increase or decrease its ownership, control or direction over securities of Prospero through market transactions, private agreements, or otherwise. Fortuna has fil

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom