|By PR Newswire||
|January 29, 2014 05:00 PM EST||
DUBLIN, January 29, 2014 /PRNewswire/ --
Research and Markets (http://www.researchandmarkets.com/research/bgdzzw/tesaros) has announced the addition of the "Tesaro's Rolapitant: Competition for Emend" report to their offering.
(Logo: http://photos.prnewswire.com/prnh/20130307/600769 )
Tesaro's rolapitant is a NK-1 inhibitor in phase III trials for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV). As such, it will compete most directly against Emend, Merck's first-in-class NK-1 inhibitor, originally approved in 2003.
Both agents attempt to address a relatively unmet need for effective prophylaxis against the CINV that occurs during the period from 24+ to 120 hours after higly-emetogenic chemotherapy is administered (Delayed Phase). Current 5-HT3 antagonists such as Zofran, Aloxi, and Kytril are available in generic forms and provide reasonable efficacy during the Acute Phase (0 to 24 hours after chemotherapy).
This report reviews the underlying rationale for NK-1 therapy, the available phase II rolapitant data and the probability of phase III success, the history of relevant precedents and the probability of regulatory success, and importantly, rolapitant's ability to compete against Emend in the marketplace.
Key Topics Covered:
CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV):
2. Classification of emetic risk and therapy
1. Rationale for use
2. Post-operative nausea and vomiting
3. Phase II trial in CINV
4. Phase III trials
CLINICAL AND REGULATORY DISCUSSION:
1. Will the phase III trials show positive efficacy outcomes?
2. Are there safety concerns?
- Clinical data from the meta-analysis and from Emend seem to confirm a benign profile
- The pharmacology of NK-1 inhibition suggest benefit and risk
- Precedents also suggest some risks
- In summary
3. Will the rolapitant program provide adequate support for approval?
- General considerations
- The Emend precedent
2. Competitive analysis
APPENDIX 1. Risk of emesis with chemotherapeutic agents
APPENDIX 2. ASCO CINV treatment guidelines
APPENDIX 3. Therapy regimens used in rolapitant and Emend trials
APPENDIX 4. Rolapitant phase II CINV trial results: Cycle 1 complete response rates by dose and phase
APPENDIX 5. Treatment-emergent/related adverse events with =2% incidence during the phase II CINV rolapitant trial (all cycles)
APPENDIX 6. Percent of patients with adverse events in the two pivotal oral regimen emend trials combined: cycle 1, hec setting, incidence =3%
- Dr. Ellen Brady
- Dr. Ilana Fogelman
For more information visit http://www.researchandmarkets.com/research/bgdzzw/tesaros
Media Contact: Laura Wood , +353-1-481-1716, [email protected]
SYS-CON Events announced today that Niagara Networks will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Oct. 24, 2016 11:45 AM EDT Reads: 1,302
In an era of historic innovation fueled by unprecedented access to data and technology, the low cost and risk of entering new markets has leveled the playing field for business. Today, any ambitious innovator can easily introduce a new application or product that can reinvent business models and transform the client experience. In their Day 2 Keynote at 19th Cloud Expo, Mercer Rowe, IBM Vice President of Strategic Alliances, and Raejeanne Skillern, Intel Vice President of Data Center Group and ...
Oct. 24, 2016 11:45 AM EDT Reads: 1,505
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Oct. 24, 2016 10:45 AM EDT Reads: 3,850
SYS-CON Events announced today that Cemware will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Use MATLAB functions by just visiting website mathfreeon.com. MATLAB compatible, freely usable, online platform services. As of October 2016, 80,000 users from 180 countries are enjoying our platform service.
Oct. 24, 2016 10:30 AM EDT Reads: 823
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Oct. 24, 2016 10:30 AM EDT Reads: 2,531
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Oct. 24, 2016 10:30 AM EDT Reads: 2,088
Virgil consists of an open-source encryption library, which implements Cryptographic Message Syntax (CMS) and Elliptic Curve Integrated Encryption Scheme (ECIES) (including RSA schema), a Key Management API, and a cloud-based Key Management Service (Virgil Keys). The Virgil Keys Service consists of a public key service and a private key escrow service.
Oct. 24, 2016 10:15 AM EDT Reads: 1,058
SYS-CON Events announced today that eCube Systems, the leading provider of modern development tools and best practices for Continuous Integration on OpenVMS, will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. eCube Systems offers a family of middleware products and development tools that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Oct. 24, 2016 10:00 AM EDT Reads: 4,492
Effectively SMBs and government programs must address compounded regulatory compliance requirements. The most recent are Controlled Unclassified Information and the EU’s GDPR have Board Level implications. Managing sensitive data protection will likely result in acquisition criteria, demonstration requests and new requirements. Developers, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by incorporating changes.
Oct. 24, 2016 09:45 AM EDT Reads: 1,685
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Oct. 24, 2016 09:15 AM EDT Reads: 4,670
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
Oct. 24, 2016 09:00 AM EDT Reads: 2,311
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Oct. 24, 2016 09:00 AM EDT Reads: 3,478
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walk you through how Oct...
Oct. 24, 2016 08:15 AM EDT Reads: 3,146
SYS-CON Events announced today that Embotics, the cloud automation company, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Embotics is the cloud automation company for IT organizations and service providers that need to improve provisioning or enable self-service capabilities. With a relentless focus on delivering a premier user experience and unmatched customer support, Embotics is the fas...
Oct. 24, 2016 08:00 AM EDT Reads: 854
DevOps is speeding towards the IT world like a freight train and the hype around it is deafening. There is no reason to be afraid of this change as it is the natural reaction to the agile movement that revolutionized development just a few years ago. By definition, DevOps is the natural alignment of IT performance to business profitability. The relevance of this has yet to be quantified but it has been suggested that the route to the CEO’s chair will come from the IT leaders that successfully ma...
Oct. 24, 2016 07:30 AM EDT Reads: 16,450