Novavax Reaches Significant Enrollment Milestone in the Prepare(TM) Phase 3 Trial of its RSV F Vaccine
- Prepare trial is assessing the efficacy of Novavax' RSV F Vaccine for infants via maternal immunization
- Enrollment of ~4,600 participants enables initiation of interim efficacy analysis
- Topline efficacy data from analysis expected in the first quarter of 2019
GAITHERSBURG, Md., May 07, 2018 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced it has reached a significant milestone in the Prepare(TM) Phase 3 clinical trial of its respiratory syncytial virus F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization. Enrollment has reached approximately 4,600 participants, of whom, at least 3,000 have received the RSV F Vaccine.
Prepare is a global, pivotal Phase 3 clinical trial of the RSV F Vaccine, in healthy, third trimester pregnant women, which initiated in December 2015. The primary objective of the Prepare trial is to determine the efficacy of maternal immunization with the RSV F Vaccine against medically significant RSV-positive lower respiratory tract infection (LRTI) in infants through a minimum of the first 90 days of life and up through the first six months of life.
"Reaching this enrollment target for the Prepare trial is a significant milestone in the advancement of our RSV F Vaccine franchise," said Stanley C. Erck, President and CEO of Novavax, Inc. "RSV remains an urgent global unmet medical need due to the mortality and morbidity associated with RSV disease in infants and the absence of a vaccine to prevent such disease. We look forward to completing the interim analysis of the Prepare trial as this is the next step on the path to filing marketing applications in the U.S. and Europe for the first-ever RSV vaccine."
Novavax will initiate a prespecified interim efficacy analysis for the Prepare trial after the last infant born to the approximately 4,600 women enrolled in the trial has been followed for six months. Novavax expects to report on the interim data in the first quarter of 2019. Assuming successful interim analysis results, the trial would be concluded without further enrollment and Novavax would file a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) with the European Medicines Agency (EMA) by the first quarter of 2020. With Fast Track designation previously granted by the FDA, the Novavax RSV F Vaccine could potentially be eligible for priority review of the BLA, which reduces the standard FDA review by four months.
In December 2017, Novavax conducted an informational analysis related to the prevention of medically significant RSV-positive LRTI in a subset of 1,300 infants from the Prepare trial. This analysis allows Novavax to conclude that the vaccine's potential observed efficacy in this subset group is in the range of 45% and 100%1.
The Prepare trial is supported by a grant of up to $89.1 million from the Bill & Melinda Gates Fund. This grant supports development activities, product licensing efforts and World Health Organization prequalification of the RSV F Vaccine.
RSV is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.2 In the U.S., RSV is the leading cause of hospitalization of infants.3 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.4 Currently, there is no approved RSV vaccine available.
About the FDA's Fast Track Drug Development Program
The Fast Track Drug Development Program was established under the FDA Modernization Act of 1997. A Fast Track designation is intended for products that treat serious or life-threatening diseases or conditions, and that demonstrate the potential to address unmet medical needs for such diseases or conditions. The program is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Specifically, Fast Track designation facilitates meetings to discuss all aspects of development to support licensure and it provides the opportunity to submit sections of a BLA on a rolling basis as data become available, which permits the FDA to review modules of the BLA as they are received instead of waiting for the entire BLA submission. In addition, priority review (6 month review versus standard 10 month review) is a potential benefit that may be available to Novavax' RSV F vaccine in the future.
Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent infectious diseases. Its RSV and influenza nanoparticle vaccine candidates are Novavax' most advanced clinical programs and are at the forefront of Novavax' efforts to improve global health. For more information, please visit www.novavax.com.
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, 2017 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.
Senior Manager, Investor & Public Relations
1 Assumes 2:1 randomization
3 Leader S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32
4 PLOS. "How immunity to respiratory syncytial virus develops in childhood, deteriorates in adults." ScienceDaily. 21 April 2016. https://www.sciencedaily.com/releases/2016/04/160421145747.htm
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
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
CTG Promotes Three Long-time Business Leaders in Europe15.2.2019 15:00:00 | Pressemelding
Bob Daelman, Guido Helsloot and Rénald Wauthier named Vice Presidents BUFFALO, N.Y., Feb. 15, 2019 (GLOBE NEWSWIRE) -- CTG (NASDAQ: CTG), a leading provider of information technology (IT) solutions and services in North America and Western Europe, announced today that three of the Company’s high-performing managers in its European business, Bob Daelman, Guido Helsloot and Rénald Wauthier, have each been named vice president. “Bob Daelman and Rénald Wauthier have proven track records of significantly expanding their respective businesses in Europe. Guido Helsloot has been key enabler in effecting two acquisitions in the past six years that expanded our operations and was again instrumental in driving our recent Tech-IT acquisition that will give CTG broader end-to-end capabilities to better-serve our clients. Together, this team has greatly contributed to our success in Europe, where CTG has recorded eight consecutive years of revenue growth,” commented Filip Gydé, current Executive Vic
Jazwares Announces Partnership with Kellytoy for Russ Berrie™ Worldwide15.2.2019 01:00:00 | Pressemelding
Sunrise, FL, Feb. 14, 2019 (GLOBE NEWSWIRE) -- Jazwares LLC, a global leader in toys and licensing, announced today that its affiliate Zag Toys, LLC (“Zag Toys”) formed a strategic partnership for their wholly owned brand Russ Berrie™, with Kellytoy, an influential manufacturer and distributor of plush toys and pet products. This relationship will carry on the 50+ year legacy of the Russ Berrie™ brand, positioning it globally as the premier plush brand on retail shelves in Fall 2019. Kellytoy will market the Russ Berrie™ brand through its global distribution channels, which include almost every market segment. “Working together with Kellytoy will maximize the Russ Berrie™ legacy,” says Judd Zebersky, Jazwares CEO and President. “By leveraging Russ Berrie™ and its reputation for quality and commitment to “Make Someone Happy™” with Kellytoy’s global footprint we’ll secure placement in retailers all around the world, putting Russ Berrie™ at the forefront of today’s plush presence at retai
PROFEPA report confirms no contamination of soil from overflow of contingency pond at the San Jose Mine, Mexico in October 201814.2.2019 19:46:00 | Pressemelding
VANCOUVER, British Columbia, Feb. 14, 2019 (GLOBE NEWSWIRE) -- Fortuna Silver Mines Inc. (NYSE: FSM) (TSX: FVI) is pleased to report that the Federal Attorney's Office for Environmental Protection (PROFEPA) has completed its investigation into the overflow of the contingency pond at the dry stack tailings facility at the San Jose Mine on October 8, 2018, which was caused by heavy seasonal rains (refer to Fortuna news release dated October 11, 2018). PROFEPA’s final report confirms that the overflow did not contaminate soil, and therefore no remediation is required. The Company awaits a final report from the Mexican National Water Commission (CONAGUA). The Company reiterates its commitment to safeguarding the wellbeing of the environment, local communities and our work force. About Fortuna Silver Mines Inc. Fortuna is a growth oriented, precious metals producer focused on mining opportunities in Latin America. Our primary assets are the Caylloma silver Mine in southern Peru, the San Jos
Cloudian HyperStore Named 2018 Product of the Year in Software-defined and Cloud Storage by Storage Magazine14.2.2019 19:10:00 | Pressemelding
Also Wins Best Hybrid Cloud Solution in 2018-2019 Cloud Awards, Further Reinforcing Company’s Object Storage Leadership SAN MATEO, Calif., Feb. 14, 2019 (GLOBE NEWSWIRE) -- Cloudian today announced two top industry awards for its HyperStore object storage platform. The awards are the latest honors for the company’s limitlessly scalable, highly cost-effective solution, which provides the industry’s best S3 compatibility and seamless data management across on-premises and public cloud environments. 2018 Software-defined and Cloud Storage Product of the Year TechTarget’s Storage magazine and SearchStorage.com named HyperStore 7 as the Gold winner in the Software-defined and Cloud Storage category of the 2018 Products of the Year Awards. The judging panel of analysts, consultants, users and TechTarget writers were “particularly impressed with [HyperStore’s] functionality.” In addition, the solution received high marks for innovation, value and ease of integration, use and manageability, en
Hot Silicon Valley Tech Firm Grows in Krakow14.2.2019 16:28:00 | Pressemelding
SignalFx Opens Research and Development and Support Office; Hires Industry Veteran Martin Burlinski, Head of Engineering, EMEA SAN MATEO, Calif., Feb. 14, 2019 (GLOBE NEWSWIRE) -- SignalFx, the leader in real-time cloud monitoring for infrastructure, microservices, and applications, is announcing the opening of a new Research, Development and Support Office in Krakow, Poland and the addition of Martin Burlinski, Head of Engineering, EMEA. The new Krakow facility will enable SignalFx to accelerate product development and provide broader global support for its customers. “We were naturally attracted to Krakow not only because of its strong existing talent pool of world-class engineers but also its proximity to recent graduates from the city’s many universities,” said Leonid Igolnik, EVP Engineering for SignalFx. “We have an immediate need for engineers to become a core part of our company working side-by-side with our Silicon Valley and Research Triangle Park teams. With a global client
HL7 and SNOMED International Announce Agreement for Free Set of Terms for Use with International Patient Summary14.2.2019 15:00:00 | Pressemelding
Orlando, Fl., Feb. 14, 2019 (GLOBE NEWSWIRE) -- SNOMED International and Health Level Seven International (HL7) announce today the formalization of a license agreement in which a relevant ‘Free for Use’ Set of SNOMED CT coded concepts will be used within the HL7 International Patient Summary (IPS). Health Level Seven International (HL7) is a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. SNOMED International is a not-for-profit, member-owned and driven international organization charged with maintaining and releasing the SNOMED CT clinical terminology product; the world’s most comprehensive clinical terminology. Presently comprised of 38 Member countries globally, SNOMED International supports the role that structured