|By Marketwired .||
|June 27, 2014 07:00 AM EDT||
TORONTO, ONTARIO -- (Marketwired) -- 06/27/14 -- Revive Therapeutics Ltd. (TSX VENTURE:RVV) ("Revive") announced today positive results from the second-half of its Phase 2a proof-of-concept study (the "Study") of REV-001 targeted for the treatment and/or prevention of opioid-induced respiratory depression for patients with sleep apnea in a post-operative setting.
The purpose of the Study is to determine the effect of an oral dose of REV-001 on alfentanil-induced respiratory depression and analgesia. The results of the Study indicate that a single dose of REV-001 may treat and/or prevent opioid induced respiratory depression in a post-operative setting, without affecting analgesia. The 16-patient, placebo-controlled, double-blind, randomized two-way crossover trial was performed by one of the leading experts in the field, Professor Dr. Albert Dahan, M.D., Ph.D., at the Leiden University Medical Center in The Netherlands. Full results of the Study to be published.
The data from the second-half of the Study in the eight patients yielded the following key findings:
-- Treatments with REV-001 was safe and well tolerated at the 50 mg dose, was not associated with serious adverse events, and there was no treatment-related discontinuations; -- A significant increase on respiratory drive as measured by inspired minute ventilation at an elevated expired PCO2 (VE55) of 36% (p = 0.039) by REV-001 as compared to placebo during high-dose alfentanil infusion induced respiratory depression; -- Treatments with REV-001 did not affect the opioids analgesic properties; and -- Treatments with REV-001 did not affect sedation.
"Overall, this is a successful study showing the respiratory stimulatory effects of REV-001, that now seems to have a novel target, that is reversal of opioid-induced respiratory depression and a unique solution in a post-operative setting," said Prof. Dr. Albert Dahan M.D., Ph.D., Principal Study Investigator and Professor of Anesthesiology at the Leiden University Medical Center, The Netherlands.
"I am very pleased with the successful completion of our first human clinical trial and that we met our milestone for REV-001 on time and on budget. The positive results of the REV-001 human clinical trial now positions the drug for partnering discussions," said Fabio Chianelli, Revive's Chief Executive Officer. "This achievement not only validates our ability to successfully repurpose drugs for new indications, but also provides us with the opportunity to advance our business development activities via licensing and acquisitions."
About Post-Operative Pain and Sleep Apnea
According to the National Center for Health Statistics, there are over 100 million surgeries performed annually in the United States with approximately 50% of those requiring post-operative pain medication such as opioids. However, opioids are known to raise serious concerns such as respiratory depression, oxygen desaturation and other side effects such as constipation, nausea and vomiting. Patients who have obstructive sleep apnea (OSA) are at a particular risk of experiencing such negative side-effects from opioids. There are 18 million Americans with sleep apnea and the condition is exacerbated with age, obesity, smoking and alcohol. According to an article titled "A Rude Awakening - The Perioperative Sleep Apnea Epidemic" published in the New England Journal of Medicine in June 2013, the risk of perioperative complications increase substantially with those who have OSA. Hospitals must take into consideration the financial implications that may become prevalent for patients who have OSA in order to reduce the risk of adverse events, such as opioid-induced respiratory depression. It has been estimated that between 29% and 41% are at high risk of opioid-induced respiratory depression. (Source: Hanna MH et al. Anesthesiology. 2005;102(4): 815-821 and Overdyk FK et al. Anesth Analg. 2007;105(2): 412-418). Currently, there are no approved drugs for OSA and the only drug treatments to counter opioid-induced respiratory depression is to administer opiate receptor antagonists such as naloxone (Narcan®). However, those antagonists eliminate the analgesic activity of the opioid drug and thus are rarely used by hospitals and healthcare facilities to prevent or treat opioid-induced respiratory depression. According to the article "A Rude Awakening - The Perioperative Sleep Apnea Epidemic", perioperative sleep apnea in the United States has been considered as an 'Epidemic'.
REV-001 is the repurposing of the drug tianeptine, an old but unique anti-depressant drug, which is marketed in Asia, parts of Europe and South America. Despite its narrow geographic scope, the decades-long clinical experience of tianeptine suggests much about its safety. In fact, tianeptine has been shown to have substantial cardiovascular and other safety at both normal doses and in overdose. (Source: Wilde, M. I. & Benfield, P. Drugs 49, 411-439 (1995)). More recently, in animal studies conducted by Revive, tianeptine was shown for the first time to prevent opioid(morphine)-induced respiratory depression in an animal model. The novel findings in Revive's animal studies enabled Revive to apply for intellectual property protection covering the use of tianeptine to treat respiratory depression.
About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. is a Canadian public company (TSX VENTURE:RVV) focused on acquiring, developing and commercializing treatments for major market opportunities such as gout, post-operative pain, and rare diseases. Revive aims to bring drugs to market by finding new uses for old drugs, also known as drug repurposing, and improving the therapeutic performance of existing drugs for underserved medical needs. Additional information on Revive is available at www.revivethera.com.
The information in this news release includes certain information and statements about management's view of future events, expectations, plans and prospects that constitute forward looking statements that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. These statements are based upon assumptions that are subject to significant risks and uncertainties. Because of these risks and uncertainties and as a result of a variety of factors, the actual results, expectations, achievements or performance may differ materially from those anticipated and indicated by these forward looking statements. Such factors include, among others, Revive's stage of development, lack of any product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market products, the ability to protect intellectual property, dependence on business partners and the prospects for negotiating joint ventures, distribution and licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to; the risks and uncertainties that Revive may not be able to successfully develop and obtain regulatory approval for its products; intellectual property disputes; future operating results are uncertain and likely to fluctuate; ability to raise additional capital; successfully establishing additional corporate collaborations, distribution or licensing arrangements; establishing marketing and the costs of launching products may be restricting; Revive's lack of experience in commercial manufacturing; increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in Revive's filings on SEDAR (www.sedar.com), including, without limitation, Revive's Filing Statement dated November 26, 2013 filed on SEDAR on November 27, 2013.
Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. Although Revive believes that the expectations reflected in forward looking statements are reasonable, it can give no assurances that the expectations of any forward looking statements will prove to be correct. Except as required by law, Revive disclaims any intention and assumes no obligation to update or revise any forward looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward looking statements or otherwise.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Nov. 27, 2015 10:00 AM EST Reads: 298
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Nov. 27, 2015 10:00 AM EST Reads: 484
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Nov. 27, 2015 09:45 AM EST Reads: 208
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Nov. 27, 2015 09:15 AM EST Reads: 283
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
Nov. 27, 2015 08:00 AM EST Reads: 373
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and t...
Nov. 27, 2015 07:45 AM EST Reads: 418
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Nov. 27, 2015 07:30 AM EST Reads: 314
Continuous processes around the development and deployment of applications are both impacted by -- and a benefit to -- the Internet of Things trend. To help better understand the relationship between DevOps and a plethora of new end-devices and data please welcome Gary Gruver, consultant, author and a former IT executive who has led many large-scale IT transformation projects, and John Jeremiah, Technology Evangelist at Hewlett Packard Enterprise (HPE), on Twitter at @j_jeremiah. The discussion...
Nov. 27, 2015 04:15 AM EST Reads: 708
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Nov. 27, 2015 04:00 AM EST Reads: 328
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Nov. 27, 2015 04:00 AM EST Reads: 219
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operations, business intelligence, and security and compliance. Asaf Yigal is co-founder and VP of Product at log analytics software company Logz.io. In the past, he was co-founder of social-trading platform Currensee, which...
Nov. 27, 2015 04:00 AM EST Reads: 191
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound...
Nov. 27, 2015 02:30 AM EST Reads: 454
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
Nov. 27, 2015 02:00 AM EST Reads: 518
In today's enterprise, digital transformation represents organizational change even more so than technology change, as customer preferences and behavior drive end-to-end transformation across lines of business as well as IT. To capitalize on the ubiquitous disruption driving this transformation, companies must be able to innovate at an increasingly rapid pace. Traditional approaches for driving innovation are now woefully inadequate for keeping up with the breadth of disruption and change facin...
Nov. 27, 2015 01:30 AM EST Reads: 463
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
Nov. 27, 2015 01:00 AM EST Reads: 463