|By PR Newswire||
|February 4, 2014 08:30 AM EST||
SAN FRANCISCO, February 4, 2014 /PRNewswire/ --
- 36 out of 47 adult subjects (77%) completed the double-blind placebo controlled, multiple dose, crossover study
- Primary endpoint met as measured by change from baseline in ADHD-RS-IV score in 5mg (p=0.003) and 10mg (p=0.037) doses which were statistically significantly superior to placebo with approximately 25% greater efficacy compared to placebo
- Secondary endpoints were also met for 5mg dose in Inattention subscale (p=0.003), Hyperactivity subscale (p=0.008), CGI-I scores (p=0.023), POMS (p=0.006), anger hostility score (p<0.001), BAS reduction in restlessness (p=0.029) and BAS Awareness of Restlessness sub score (p=0.003)
- The Company has initiated a review of strategic options for the ADHD program
Amarantus Bioscience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced positive clinical data for Eltoprazine in a Phase 2a clinical study Adult Attention Deficit Hyperactivity Disorder. The results from the study demonstrated statistically significant improvements of both doses of 5mg and 10mg vs. placebo in a range of ADHD clinical measures. Adult ADHD represents a $5B market opportunity.
"Following a thorough statistical review of the data announced by Psychogenics in 2008 by an independent clinical CRO retained for due diligence purposes, an updated study report was submitted in the Investigator's Brochure in 2010 that was better than originally reported," said David A. Lowe, PhD member of the Amarantus Board of Directors. "There is a significant need for non-stimulant ADHD treatments in the marketplace, especially in light of recent regulatory oversight of abuse of currently approved treatments. We believe Eltoprazine may fill this market need."
Eltoprazine is a 5HT1a/1b partial agonist small molecule drug candidate has a well-established safety profile, having been dosed in over 700 patients to date. The study entitled "The Effects of Eltoprazine on Symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in Adults: A Double-Blind, Multiple Dose, Crossover, Safety and Preliminary Efficacy Trial" enrolled 47 patients (48 enrollees were planned), with 36 patients completing the study. The study was conducted at 4 centers in the United States, including Duke University Medical Center, Riley Hospital for Children, NeuroScience, Inc. and UCI Child Development Center.
The primary objective of the study was to compare the effects of two doses of eltoprazine (5mg and 10mg) with placebo on symptoms of ADHD in adults. The primary efficacy parameter is ADHD-RS-IV. The secondary efficacy parameters were to compare two doses of eltoprazine (5mg and 10mg) versus the Conner's Continuous Performance Test (CPT), the Investigator's Clinical Global Impression-Improvement (CGI-I), the safety/tolerability of multiple doses of eltoprazine and to assess the safety after discontinuation.
SUMMARY OF THE DATA:
- The data produced demonstrated that at both 5mg and 10 mg, the study met its Primary endpoint as measured by change from baseline in ADHD-RS-IV score in 5mg (p=0.003) and 10mg (p=0.037) doses which were statistically significantly superior to placebo with approximately 25% greater efficacy compared to placebo. Total ADHD-RS-IV scores improved by 13.6, 17.9 and 17.4 points from baseline for placebo, 5mg and 10mg of Eltoprazine, respectively. Inattention, Hyperactivity, and Impulsivity ADHD-RS-IV subscales were also analyzed.
- For the Inattention subscale, both 5mg and 10mg groups showed a statistically significant benefit over placebo (0.003 and 0.039, respectively).
- For the Hyperactivity subscale, the 5mg dose showed a statistically significant benefit in favor of Eltorprazine treatment compared to placebo (p=0.008); the 10mg dose was superior to placebo, however the difference was not statistically significant (p=0.130).
- For the Impulsivity subscale, no significant benefit was observed for either drug dose compared to placebo.
- Both 5mg and 10mg demonstrated significantly greater improvement over placebo for CGI-I scores (p=0.023 and 0.004, respectively).
- The percentage of subjects who were considered improved by the investigator was 57.9% for placebo, 68.4% for 5mg, and 81.1% for 10mg. The percentage difference was significant between 10mg and placebo (0.029), but it was not between 5mg and placebo (p=0.342).
The results indicate the overall positive outcomes reported on the ADHD-RS-IV were largely driven by the Inattention and Hyperactivity subscales. This phenomenon was expected because most enrolled subjects had primary deficit in Inattention at baseline. Significant benefits of the active treatments were also observed for the following secondary efficacy variables:
Profile of Mood States (POMS):
- The 5mg dose was statistically significantly better than placebo for POMS total score (p=0.006)
- Both the 5mg and 10mg groups were statistically significantly better than placebo for anger-hostility score (p<0.001 and p=0.036, respectively)
- The 5mg group was also statistically significantly better than placebo for tension anxiety score (p=0.046)
Barnes Akathisia Scale (BAS)
- Both 5mg and 10mg groups showed a reduction in restlessness and were statistically significantly better than placebo for BAS (p=0.029 and p=0.007, respectively)
- Both 5mg and 10mg groups were statistically significantly better than placebo for Awareness of Restlessness subscore (p=0.003 and p<0.001, respectively).
- The 10mg group was also statistically significantly better than placebo for Distress Related Restlessness subscore (p=0.047)
Abnormal Involuntary Movement Scale (AIMS)
- 10mg showed a significantly greater reduction in abnormal movements than placebo (p<0.001)
There were no serious adverse events (SAEs). Most adverse events were mild of moderate in severity, with only 2 severe treatment-related adverse events with the 5mg/day (hypnagogic hallucination and constipation) and 1 severe treatment-related adverse event with the 10mg/day (fatigue).
"We are pleased to update the marketplace on the Eltoprazine ADHD program at this time, as we have initiated a review of strategic options for the further development of the program. We believe there is significant value to be unlocked with this program and intend to pursue business development-related transactions that we believe will bolster shareholder value as we prepare to up-list to a national stock exchange." said Gerald Commissiong, President & CEO of Amarantus Bioscience Holdings.
About Attention-Deficit Hyperactivity Disorder (ADHD)
ADHD is a neurobehavioral developmental disorder affecting about 3-5% of the world's population under the age of 19. It typically presents itself during childhood, and is characterized by a persistent pattern of inattention and/or hyperactivity, as well as forgetfulness, poor impulse control or impulsivity, and distractibility. There is a clear need for new non-stimulant therapies for ADHD, currently considered to be a persistent and chronic condition for which no medical cure is available. ADHD is one of the most common psychiatric disorders in children and adolescents with approximately 7.8 percent of all U.S. school-age children, or about 4.4 million children aged 4 to 17 years, having been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). Over 8 million adults in the US also exhibit the symptoms of ADHD, while only an estimated 600,000 are being treated. Adult ADHD is characterized by difficulty maintaining attention, as well as hyperactivity and impulsive behavior. Adult ADHD symptoms can lead to a number of problems, including unstable relationships, poor work or school performance, and low self-esteem. Treatment for adult ADHD is similar to treatment for childhood ADHD, and includes stimulant drugs or other medications, and psychological counseling.
The ADHD market is valued at over $3.5 billion dollars, with approximately 35 million prescriptions written annually.
Amarantus is a biotechnology company developing treatments and diagnostics for diseases associated with neurodegeneration and protein misfolding-related apoptosis. The Company has licensed Eltoprazine a phase 2b ready indication for Parkinson's Levodopa induced dyskinesia. The Company has an exclusive worldwide license to the Lymphocyte Proliferation test ("LymPro Test®") for Alzheimer's disease and owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor ("MANF") and is developing MANF-based products as treatments for brain disorders. Amarantus is a Founding Member of the Coalition for Concussion Treatment (#C4CT), a movement initiated in collaboration with Brewer Sports International seeking to raise awareness of new treatments in development for concussions and nervous-system disorders. The Company also owns intellectual property for the diagnosis of Parkinson's disease ("NuroPro") and the discovery of neurotrophic factors ("PhenoGuard"). For further information please visit http://www.Amarantus.com, or connect with the Company on Facebook, LinkedIn, Twitter and Google+.
Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are forward-looking statements." These forward-looking statements generally are identified by the words believes," project," expects," anticipates," estimates," intends," strategy," plan," may," will," would," will be," will continue," will likely result," and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements.
Aimee Boutcher, Director of Investor Relations
Amarantus Bioscience Holdings, Inc.
+1-408-737-2734 x 101
SOURCE Amarantus Bioscience Holdings, Inc.
"Qosmos has launched L7Viewer, a network traffic analysis tool, so it analyzes all the traffic between the virtual machine and the data center and the virtual machine and the external world," stated Sebastien Synold, Product Line Manager at Qosmos, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 11:00 AM EST Reads: 849
"Coalfire is a cyber-risk, security and compliance assessment and advisory services firm. We do a lot of work with the cloud service provider community," explained Ryan McGowan, Vice President, Sales (West) at Coalfire Systems, Inc., in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 11:00 AM EST Reads: 974
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for ...
Dec. 8, 2016 10:30 AM EST Reads: 520
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Dec. 8, 2016 10:30 AM EST Reads: 7,292
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Dec. 8, 2016 10:05 AM EST Reads: 129
SYS-CON Events announced today that Dataloop.IO, an innovator in cloud IT-monitoring whose products help organizations save time and money, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Dataloop.IO is an emerging software company on the cutting edge of major IT-infrastructure trends including cloud computing and microservices. The company, founded in the UK but now based in San Fran...
Dec. 8, 2016 10:00 AM EST Reads: 580
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
Dec. 8, 2016 10:00 AM EST Reads: 978
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Dec. 8, 2016 09:45 AM EST Reads: 1,918
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 8, 2016 09:30 AM EST Reads: 591
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Dec. 8, 2016 09:15 AM EST Reads: 929
"We are a leader in the market space called network visibility solutions - it enables monitoring tools and Big Data analysis to access the data and be able to see the performance," explained Shay Morag, VP of Sales and Marketing at Niagara Networks, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 09:12 AM EST Reads: 197
"We analyze the video streaming experience. We are gathering the user behavior in real time from the user devices and we analyze how users experience the video streaming," explained Eric Kim, Founder and CEO at Streamlyzer, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 09:00 AM EST Reads: 585
In his session at Cloud Expo, Robert Cohen, an economist and senior fellow at the Economic Strategy Institute, provideed economic scenarios that describe how the rapid adoption of software-defined everything including cloud services, SDDC and open networking will change GDP, industry growth, productivity and jobs. This session also included a drill down for several industries such as finance, social media, cloud service providers and pharmaceuticals.
Dec. 8, 2016 09:00 AM EST Reads: 459
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Dec. 8, 2016 08:45 AM EST Reads: 887
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
Dec. 8, 2016 08:45 AM EST Reads: 1,871