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Amarantus Provides Program Update on Phase 2b Eltoprazine for Parkinson's Disease and Adult ADHD
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SAN FRANCISCO and GENEVA, Sept. 17, 2014 (GLOBE NEWSWIRE) -- Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of diagnostics and therapeutics for Alzheimer's disease, Parkinson's disease and orphan ophthalmological disorders, today provided a program update on its Phase 2b-ready Eltoprazine program for Parkinson's disease levodopa-induced dyskinesia patients ("PD LID") and adult attention deficit and hyperactivity disorder ("Adult ADHD"). The company expects to initiate its Phase 2b PD LID clinical trial in the fourth quarter of 2014 or early in 2015.
Eltoprazine for Parkinson's disease levodopa-induced dyskinesia patients ("PD LID")
"We have spent the last six months evaluating the historical Eltoprazine data and laying out the clinical program going forward," said Dr. Charlotte Keywood, Chief Medical Officer of Amarantus' therapeutics division. "We have designed a robust Phase 2b study based upon a thorough evaluation of state of the art trial designs for drugs in the PD LID indication. We will be engaging with the FDA in the coming weeks to commence the regulatory process for the initiation of the PD LID clinical program in the US."
Since the in-license of Eltoprazine in the first quarter of 2014, Amarantus has accomplished the following milestones:
1. Undertaken a comprehensive review of the existing Eltoprazine data package, to determine the development strategy for Phase 2b to registration in PD-LID, including pharmacokinetic modelling and dose definition
2. Conducted additional manufacturing work to support the qualification of the existing Eltoprazine stockpile for use in the proposed Phase 2b PD LID trial
3. Designed the Phase 2b trial in consultation with Key Opinion Leaders in PD LID
4. Identified the principle investigator and key sites for PD LID Phase 2b clinical trial
5. Commenced supporting work for initiation of the trial by the end of 2014
6. Finalized the clinical trial synopsis for submission to the FDA
In preparation for the trial initiation, the Company has identified the following important steps on the path to Phase 2b initiation:
1. Request pre-IND meeting with the FDA
2. Submit IND to the FDA
3. Obtain IND approval
4. Start enrolment for the Phase 2b PD LID clinical trial in the USA
5. Submit Phase 2b design to EMEA
6. Obtain agreement on Phase 2b trial design with EMEA
7. Start enrolment for the Phase 2b PD LID clinical trial in Europe
"We are very pleased that our Eltoprazine program has progressed so rapidly under the direction of Dr. Keywood and Dr. Lowe," said Gerald E. Commissiong. "The initiation of the Phase 2b trial in PD LID will mark a major milestone for Amarantus. We expect to be in the clinic for this important indication by early 2015. PD LID represents a significant unmet medical need for Parkinson's disease patients."
Eltoprozine for adult attention deficit and hyperactivity disorder ("Adult ADHD")
Commissiong added, "concurrently the Company is taking the first steps in a second important indication for this compound -- Adult ADHD. Adult ADHD represents another massive market opportunity, where non-stimulant drugs are highly sought after to replace current marketed drugs that are highly prone to addiction."
"The non-stimulant Adult ADHD competitive landscape is now maturing to the point where there is greater definition on approvable endpoints, making the planning of a Phase 2b trial in Adult ADHD feasible," said David A. Lowe, PhD, member of the Amarantus Board of Directors. "Regulatory bodies in the United States and in Europe have identified Adult ADHD as a significant unmet medical need, thereby increasing the importance of Eltoprazine's positive Adult ADHD Phase 2a clinical trial data to Amarantus' pipeline."
Amarantus will evaluate the initiation of a Phase 2b clinical development program for Eltoprazine in Adult ADHD after the PD LID program is underway.
About Eltoprazine
Eltoprazine is a small molecule 5HT1a/1b partial agonist in clinical development for the treatment of PD LID and Adult ADHD. Eltoprazine has been evaluated in over 600 human subjects to date, with a very strong and well-established safety profile. Eltoprazine was originally developed by Solvay Pharmaceuticals for the treatment of aggression. Upon Solvay's merger with Abbott Pharmaceuticals, the Eltoprazine program was out-licensed to PsychoGenics. PsychoGenics licensed Eltoprazine to Amarantus following successful proof-of-concept trials in PD LID and adult ADHD.
About Parkinson's disease Levodopa-induced dyskinesia (PD LID)
Parkinson's disease is a chronic, progressive motor disorder that causes tremors, rigidity, slowed movements and postural instability. The Parkinson's Disease Foundation estimates that there were approximately one million people living with Parkinson's disease in the United States in 2011. The most commonly-prescribed treatments for Parkinson's disease are levodopa-based therapies. In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease. The therapeutic efficacy of levodopa is gradually lost over time, and abnormal involuntary movements, dyskinesias, gradually emerge as a prominent side-effect in response to previously beneficial doses of the drug. Levodopa-induced dyskinesia can be severely disabling, rendering patients unable to perform routine daily tasks.
About adult attention deficit and hyperactivity disorder (Adult ADHD)
Attention-deficit/hyperactivity disorder (ADHD) is a common and impairing neuropsychiatric condition, with a total worldwide market size exceeding $8 billion, growing at an annual rate of 10%. Once believed to only affect children, ADHD is now known to persist into adolescence and adulthood in a sizeable number of cases. Approximately 4-5% of adults worldwide are affected with ADHD. Most adults with ADHD remain undiagnosed and untreated. While approved stimulant medications have been shown to be effective and safe for the treatment of ADHD, up to 30% to 50% of those who are prescribed stimulants for ADHD either do not respond to or do not tolerate these treatments; the utility of stimulants is further hindered by potential risk for abuse (stimulants are controlled substances regulated by the DEA and other international government agencies). Consequently, it is important to develop safe and effective non-stimulant treatment alternatives. Eltoprazine positive phase 2a data for Adult ADHD.
This is a no brainer from here. Anyone debating on adding.... this IS the time.
Great day! 5 star post!
Thanks for the brillant post! Wow. Another savior.
Nope...just call em like I see em. Have a great day too!!
Missed your buy in in the .09's?? You had a chance. 80 million shares traded higher than we are at now last week. New base is in IMO. You will be hard pressed to buy anything below .105
OK..Thanks for sharing....please wait for it down there before getting some!! Much appreciated! Wow. Glad you're so smart!! Just amazing!! wow. OK...SO are you gonna wait for the 3's or low 4's??
for
yup....doctors are bright.
Agreed...Same price as yesterday this time...lol But now 40 million shares are in stronger hands.
Nice volume pouring in....afternoon rush!! Look out .20!
100 percent agree risk. The volume from their group is less than 1/4th of 1 percent of the float. This is not going to spoil the show by any means.
Couple swing traders having fun today but the majority are longs accumulating. I bet the groups only contributed to 1-2 million shares traded. That's 170-340k. When this is in the .20's and .30's most of the flippers will be long gone and the longs will be multiplying their money.
Have a great weekend all!! I see low .20's possibly by tuesday. IMO
Amarantus and BSI Proudly Announce BIO CEO & President Jim Greenwood as Panelist for 3rd Alzheimer's Focused #C4CT Concussion Awareness Summit at United Nations
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MINNEAPOLIS and NEW YORK, July 22, 2014 (GLOBE NEWSWIRE) -- Brewer Sports International (BSI), a multi-faceted global sports advisory firm, and Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to cell cycle dysregulation, endoplasmic reticulum stress, neurodegeneration and apoptosis, are proud to announce the Honorable Jim Greenwood, President & CEO of the Biotechnology Industry Organization (BIO), as a panelist for the 3rd Alzheimer's focused #C4CT (Coalition for Concussion Treatment) Concussion Awareness Summit, powered by MDM Worldwide on Thursday, July 31, 2014, at the United Nations in New York City, NY.
"This Summit brings together a diverse range of thought leaders focused on addressing one of the pressing medical challenges we face," Greenwood said. "It offers the opportunity to dive deep into the latest research, to highlight the policies needed to encourage and incentive increased investment in new drugs and therapies and to mobilize our efforts to increase awareness. It will be a wide-ranging, informative and frank conversation, and one I am greatly looking forward to participating in."
As President & CEO of BIO, Greenwood leads the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. Prior to BIO, Greenwood held elected office for 24 years. He served in the Pennsylvania House and Senate before being elected to the U.S. House of Representatives.
The #C4CT Concussion Awareness Summit is being convened on July 31, 2014 to explore the potential link between TBI and Alzheimer's disease. A diverse working group of clinicians, medical researchers, policy makers, international diplomats, athletes, celebrities, and philanthropic organizations will be assembled to raise awareness, advance clinical research, and develop public policy in order to address this major unmet medical need and public health issue.
To register or for additional information, please visit www.c4ctsummit.com. For further event questions, please contact Lindsay Lommel at lindsay.lommel@thebrewergroup.com. For sponsorship information please visit: http://www.c4ctsummit.com/sponsorship-opportunities/.
We are establishing a well-oiled clinical organization capable of translating protocols to practice, and ultimately to data at a very rapid pace. - See more at: http://www.thechairmansblog.com/amarantus-bioscience/gerald-commissiong/understanding-data-presented-aaic-amarantus-well-positioned-heading-c4ct/#sthash.7m56h0Op.HexIQ7Ls.dpuf
I base my decision to invest on the company and its actions. If I based it on a message boards actions I'd be broke. Weed through the bad apples and pick a few you trust and ignore the rest.
We are still 20% plus where we were a few weeks ago and in reality although the actual high Tues. says .1754 there were only a few trades above .16 so we are not as far off the actual high as you may think.
There are still plenty holding on to their .13-.16 shares that will wait for higher.
As the price swings so will the agendas. The visions are clear.
Yup! Great amount of new atronger hands on board the last few days!
This is primed for more!
They are co sponsoring the event. Scroll to the bottom.
http://www.c4ctsummit.com/about-the-summit/
That sounds like too much work....But your brokers are happy!
I don't have time to flip all day.
Wait till we get the 50 million share plus day. Then we'll be moving!!
All regular trends are going to be retrended...lol
It was on CBS evening news too. tonight
Was well deserved. Nice to see 20's
I thought the day it was published on May 1st. completed or approved the application??
LOL That was before the LPC capital was announced. Good try!
Filed Application Oct. 24th. 2013
Received at International Bureau Nov. 7th. 2013
Validated April 4th. 2014
Published May 1st. 2014
Report generated today.
Complete.
Classic!
I never said there would be revenue by the end of the year.
Projections of revenue perhaps and paving the way for revenue and more exposure...yes
I/he didn't ask to the extent of revenue...again your dancing.
yea dancing.
A simple yes or no would suffice.
Angry Goats question.
"Are you saying that Gerald and his team are blowing smoke about the effectiveness of Lympro? "
Great points. It simply comes down to percentages and whether you believe the team will perform. I have always been impressed with the amount of exposure GC has given AMBS and from the looks of it it's just the beginning. If you look at the 3 year chart below the 6 month an explosion is more likely than an Implosion IMO
Great post...and as usual goes unanswered...or danced around...lol
good luck!! I am sure the person who bought your shares will be holding them for more!!
Way to go zoom!
Again. Good luck with that. Let us know when we should pull the trigger!! lol