Welcome!

News Feed Item

First Patient Enrolled in Northern Hemisphere for Phase 3 Study of Favipiravir for Influenza

MediVector, Inc. Announces the Successful Initiation of Its Phase 3 Program for the Investigational Influenza Drug

BOSTON, Jan. 16, 2014 /PRNewswire/ -- MediVector, Inc. today announced the enrollment of its first patient in the United States in one of two FAVOR favipiravir Phase 3 studies in adults with uncomplicated influenza.  This multi-center, double-blind, placebo-controlled study is expected to enroll over 1,000 patients in participating clinics and practices in North, Central, and South America. 

"The burden of seasonal influenza is substantial, resulting in hundreds of thousands of deaths each year worldwide.  We see the potential for this drug to serve a crucial public health need," Dr. Carol Epstein, Executive Vice President and Chief Medical Officer of MediVector, Inc. said.  "With illness and death from pandemic flu an ever present threat, the importance of new drugs, like favipiravir, become more and more significant.  Many strains of influenza have developed resistance to currently-available drugs."

The Phase 3 FAVOR study follows the successful completion of a Phase 2, multi-center, double-blind, placebo-controlled study in the United States with favipiravir in patients with uncomplicated influenza. In the Phase 2 study, twice daily dosing of favipiravir demonstrated statistically significant decreases in time to alleviation of each of six influenza symptoms consistent with uncomplicated influenza (cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue).  In addition, subjects who received favipiravir cleared the virus statistically significantly more quickly compared with placebo. Favipiravir appeared safe and well tolerated with no serious adverse events reported during this study. 

The investigational drug candidate (favipiravir) is being developed by BioDefense Therapeutics (BD Tx), a Joint Product Manager within the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office. A component of the Joint Program Executive Office for Chemical and Biological Defense, JPM-MCS aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance our nation's biodefense response capability. For more information, visit www.jpeocbd.osd.mil.

About MediVector, Inc.
MediVector, Inc. is a Boston-based drug development company focused on developing innovative therapeutic agents using streamlined processes to address unmet medical needs and improve public health. 

About Favipiravir
Favipiravir (originally known by the code name, T-705) is a novel anti-viral compound that works against a different viral enzyme target than approved antiviral agents used to treat people who have become ill with influenza.   Favipiravir inhibits the enzyme viral RNA polymerase that functions to make copies of the viral RNA segments and to synthesize mRNAs that produce the proteins that will form new viruses.  Favipiravir may be useful for the treatment of influenza infections based on its potent and selective inhibitory activities against a broad spectrum of influenza A, B, and C viruses, including strains poorly susceptible to existing drugs and its efficacy against highly pathogenic avian influenza and avian influenza virus A (H5N1) isolated from humans and birds in both in vivo and in vitro studies.  Preclinical studies indicate that favipiravir may also be effective against a variety of other viral illnesses.

Contact | Sonya Khan, 617.398.5941, [email protected]

SOURCE MediVector, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
The IoT has the potential to create a renaissance of manufacturing in the US and elsewhere. In his session at 18th Cloud Expo, Florent Solt, CTO and chief architect of Netvibes, will discuss how the expected exponential increase in the amount of data that will be processed, transported, stored, and accessed means there will be a huge demand for smart technologies to deliver it. Florent Solt is the CTO and chief architect of Netvibes. Prior to joining Netvibes in 2007, he co-founded Rift Technol...
If there is anything we have learned by now, is that every business paves their own unique path for releasing software- every pipeline, implementation and practices are a bit different, and DevOps comes in all shapes and sizes. Software delivery practices are often comprised of set of several complementing (or even competing) methodologies – such as leveraging Agile, DevOps and even a mix of ITIL, to create the combination that’s most suitable for your organization and that maximize your busines...
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
New Relic, Inc. has announced a set of new features across the New Relic Software Analytics Cloud that offer IT operations teams increased visibility, and the ability to diagnose and resolve performance problems quickly. The new features further IT operations teams’ ability to leverage data and analytics, as well as drive collaboration and a common, shared understanding between teams. Software teams are under pressure to resolve performance issues quickly and improve availability, as the comple...
The proper isolation of resources is essential for multi-tenant environments. The traditional approach to isolate resources is, however, rather heavyweight. In his session at 18th Cloud Expo, Igor Drobiazko, co-founder of elastic.io, will draw upon their own experience with operating a Docker container-based infrastructure on a large scale and present a lightweight solution for resource isolation using microservices. He will also discuss the implementation of microservices in data and applicat...
Join IBM June 8 at 18th Cloud Expo at the Javits Center in New York City, NY, and learn how to innovate like a startup and scale for the enterprise. You need to deliver quality applications faster and cheaper, attract and retain customers with an engaging experience across devices, and seamlessly integrate your enterprise systems. And you can't take 12 months to do it.
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, will discuss how research has demonstrated the value of Machine Learning in delivering next generation analytics to im...
This is not a small hotel event. It is also not a big vendor party where politicians and entertainers are more important than real content. This is Cloud Expo, the world's longest-running conference and exhibition focused on Cloud Computing and all that it entails. If you want serious presentations and valuable insight about Cloud Computing for three straight days, then register now for Cloud Expo.
As you respond to increasing requests for new analytics, you need fast and flexible technology in your arsenal so that you can deploy the right workload to the right platform for the need at hand. Do you need self-service and fast time to value? Do you have data and application control and privacy needs, along with strict SLAs to meet? IBM dashDB™ is data warehouse technology powered by in-memory computing and in-database analytics that are designed for fast results, scalability and more.
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
IoT device adoption is growing at staggering rates, and with it comes opportunity for developers to meet consumer demand for an ever more connected world. Wireless communication is the key part of the encompassing components of any IoT device. Wireless connectivity enhances the device utility at the expense of ease of use and deployment challenges. Since connectivity is fundamental for IoT device development, engineers must understand how to overcome the hurdles inherent in incorporating multipl...