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Seems to be churning pretty well yesterday and today. Nice consolidation after Mondays spike!
I completely agree!!!much thanks to all I this board!! Very thankful to have come across the DD put forward here!
CUR...thanks for the chart...now up 18% intraday!
CUR...anyone join here? Up 10%. PI results published I. Peer reviewed journal...
Final Results Of Neuralstem Phase I Stem Cell Trial In Amyotrophic Lateral Sclerosis Published In Annals of Neurology
ROCKVILLE, Md., March 17, 2014 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that the final results from the Phase I safety trial using NSI-566 spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) were published in the peer-reviewed journal, "Annals of Neurology" http://onlinelibrary.wiley.com/doi/10.1002/ana.24113/full. In "Intraspinal Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis: Phase I Trial Outcomes," results were updated from Phase I interim data, reported earlier, to include data from the last six patients in the trial. These six patients were the first to receive cervical stem cell transplants. Three of them were also the first to be transplanted along the length of their spines, in both the lumbar and the cervical regions. The results showed that NSI-566 human spinal cord stem cells can be safely transplanted in both the lumbar and cervical spinal cord segments, did not accelerate disease progression, and warrant further study on dosing and therapeutic efficacy. Furthermore, the researchers were able to identify potential therapeutic windows, suggesting that more injections, as well as multiple injections, are better and may increase both the length and the magnitude of the potential benefits. This is consistent with the hypothesized neuroprotective mechanism-of-action for this cell therapy.
Photo - http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO
Since concluding Phase I, the trial has progressed to Phase II at three centers, Emory University Hospital in Atlanta, Georgia, the ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, and Massachusetts General Hospital in Boston, Massachusetts, which treated its first patient in February. Treatment of three of the five Phase II cohorts has been completed.
"Although this was a Phase I trial, and functional outcome data were collected for the purpose of assessing safety, we performed secondary analyses of these data as a means to gain insight into how cellular transplantation affected disease progression rates and to inform outcome assessment approaches in future trial phases," said Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute, Director of Research of the ALS Clinic at the University of Michigan Health System, principle investigator for the NSI-566/ALS trial and lead author. Dr. Feldman is also an unpaid consultant to Neuralstem.
"Pre-surgical disease progression rates for the various functional outcome measures were calculated to create slopes for each patient, so that we could determine if post-surgical data points, at 6, 9, 12 and 15 months, improved relative to predicted points. We also did analyses to determine which, if any, functional outcome assessment most closely correlated with the overall ALSFRS-R scores," said Dr. Feldman. "Comparison of the outcome data to predicted outcome points in group E (patients who received both lumbar and cervical injections) revealed improvements in a significant number of measures at 6, 9, 12 and 15 months post-surgery. Overall, 50% of the patients in the trial showed improvement across multiple clinical measures at the same time points. We also found that a measure of grip strength correlated most closely with the overall ALSFRS-R scores.
Dr. Feldman added, "Finally, we conducted an analysis to identify the most biologically active period of the injected cells for the patients receiving both lumbar and cervical injections. This analysis reveals that the maximal periods of benefit correlate with the two surgical interventions. Importantly, as the 'bell-shaped curve' associated with each intervention is likely due to disease progression, increasing the total cell dose, and applying multiple applications of these stem cells, may increase both the length and magnitude of the potential benefit. We are of course exploring this very dosing regimen in our ongoing Phase II trial."
"The completion of this Phase I study is a major milestone for the testing of intraspinal stem cell therapy for ALS," said Jonathan Glass, MD, Professor of Neurology and Pathology, Emory University School of Medicine and Director of the Emory ALS Center, site principal investigator and a senior study author. "We have now shown that the procedure is safe for both lumbar and cervical injections, allowing us to move forward with an aggressive program to test whether this treatment will improve the course of disease for patients with ALS."
"This peer-reviewed article is the first such report of cervical and dual-targeted intraspinal transplantation of neural stem cells in ALS subjects," said Karl Johe, PhD, Neuralstem's Chairman of the Board and Chief Scientific Officer. "We believe our cells offer a means to replace lost cells, provide neurotrophic support, and improve the diseased microenvironment. This study demonstrates these factors, and that the cells and the novel surgical route of administration are safe and well-tolerated. Our ability to directly inject cells into the cervical regions of the spinal cord represents a significant advance in the field of cell therapy.
"We would like to thank the incredible teams at both Michigan and Emory who made this study possible, and who continue working with us today in our ongoing Phase II trial. We'd like to give special thanks to Dr. Jonathan Glass, Director of the Emory ALS Center, the Emory site principle investigator, and Dr. Nick Boulis, Associate Professor of Neurosurgery at Emory School of Medicine, the surgeon for all of the Phase I surgeries, and the inventor of the spinal-mounted stabilization and injection platform and floating cannula surgical devices used to deliver the cells," concluded Dr. Johe.
About Neuralstem
Neuralstem's patented technology enables the production of neural stem cells of the brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glial cells. Neuralstem's NSI-566 spinal cord-derived stem cell therapy is in Phase II clinical trials for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease. Neuralstem has been awarded orphan status designation by the FDA for its ALS cell therapy.
In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury and ischemic stroke. The company has received FDA approval to commence a Phase I safety trial in chronic spinal cord injury.
Neuralstem also maintains the ability to generate stable human neural stem cell lines suitable for systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate neurons, possibly reversing pathologies associated with certain central nervous system conditions. The company has completed a Phase I safety trial evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive disorder (MDD). Additional indications might include traumatic brain injury (TBI), Alzheimer's disease, and post-traumatic stress disorder (PTSD).
For more information, please visit www.neuralstem.com or connect with us on Twitter, Facebook and LinkedIn
Cautionary Statement Regarding Forward Looking Information:
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2013.
Replies:
Very Nice...Thanks for the post. CUR
Citrati on 3/17/2014 9:22:44 AM
Report TOS
Here you go...
https://vascepasavings.com
Also, more positive on Friday ...
http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/03132014/stem-cell-agency-approves-72-million-accelerate
CUR....This may have boosted share price on Friday...
Link to legislation proposed regarding stem cells...
http://www.boxer.senate.gov/en/press/releases/031314a.cfm
Link to legislation proposed on Friday regarding stem cells...
http://www.boxer.senate.gov/en/press/releases/031314a.cfm
CUR....
http://stockcharts.com/h-sc/ui?s=CUR
$3.90 resistance was broken and MACD crossover occurred on Friday.
Link back for DD
We are at 3.98 in AH ...FWIW. :)
Do you have a link for this?? According to the trial on clinical trials.gov they are not completing the trial until Sept of this year. I don't think they can release results before then...
http://www.clinicaltrials.gov/ct2/show/NCT01087697?term=Tengion&rank=8
I was really surprised and thankful he said that! Must have known we would be listening ;) I think the baboon results for pertussis will give us a nice boost into Trimesta results. It's like a perfect storm!!!
CUR...breakout today ahead of data release for their PII ALS trial. One of the patients has been blogging post op on her progress. That can be found here...http://aprilals.com/2013/11/24/post-stem-cell-surgery-pics-video/
Here's some info on the company and trial..http://smithonstocks.com/neuralstem-sizing-up-potential-key-events-of-2014/
More info on ALS trial..CUR...breakout today ahead of data release for their PII ALS trial. One of the patients has been blogging post op on her progress. That can be found here...http://aprilals.com/2013/11/24/post-stem-cell-surgery-pics-video/
Here's some info on the company and trial..http://smithonstocks.com/neuralstem-sizing-up-potential-key-events-of-2014/
Will post more DD later. May be a good look into PII data release. The company will be presenting at a conference and the patient April is supposed to be attending as well. I will post a link with the conference info later this evening. If my memory serves me correctly the conference is April 6-10.
I urge everyone to read the patient blog. Very informative info in her personal story.
Have a good weekend everyone!
That's right! Looking to stay on this bull for longer than 8 seconds though.. ;)
I'm going to be anticipating Mondays open all weekend. I think once word spreads over the weekend on the new legislation there could be heavy volume in on Monday.
All in my opinion of course!
I added another 1,000 shares today. Glad I did!!
I think we will see this move into the close really well!
We got $3 in after hrs. ;)
Sheff is back in. :)
I'm guessing that was the Sheff effect you saw with the sudden volume spike
SYN...in addition to the catalyst for Trimesta results on April 26th, they will also be disclosing results from the baby baboon trial for Pertussis within the next few weeks. This was mentioned by the CEO during his presentation at the Roth conference. If you listen to the presentation one would be heavily inclined to believe the results are positive based on his comment that he said," I can't discuss results but lets just say I'm smiling"
Does anyone know what broker is officially no longer loaning shares for shorts? Effective date is today/tmw. I read this on another board but thought it could be related to our spike today and could lead to another tmw.
Do you have a link? I was unaware of new rules for shorters. It may be the reason another position I'm in shot up today on above avg volume.
Forgive my post if it's been discussed but BTD submission was going to be submitted by the end of Q1...will that be PR'd so that we know exactly when the 60 day clock starts?
I feel like I've asked this but my memory is blurry on the response
TIA
What is going on? Shorts covering in anticipation for BTD application?
Very nice whatever it is!
I was hoping you would come by for a TA update! Thanks Tom!
Salegov and Will...both of you guys are correct. The amendment is being made to increase dosing which is why a PIIa is conducted. It's for dosage adjustment and safety measure. This in my opinion is a positive because the TRAE must be low so they are going to capitalize on that by seeing if changing the dosing schedule will provide additional efficacy to patients.
PIIb will have a focus more in efficacy and these modified dosing schedules will still be assessed for safety as well.
GL
Thanks for posting the link. So after listening to the presentation I'm even more excited about things going forward. I was unaware of the baby baboon data for pertussis that will be released in a few weeks. Should be a nice primer to Trimesta results.
Also was unaware that the C-IBS trial could potentially be a PIII instead of a PII. Very positive! Does anyone know when the meeting with the FDA will take place for further clarification?
C. diff is definitely the most intriguing of all and a good reason to stay long!
Here's the thing...they didn't have to execute the option and purchase these shares right now. They could easily wait until later to purchase these shares because they have 10 yrs to do so. In my opinion it's very positive that they converted these options and purchased them at .80 a share. It's a discount but only 10% less than were we are now.
Still a strong vote of confidence in the direction ONCS is headed!!
Absolutely!!! Is there an exact date for ALS data release in April?
Ok on the road right now but I will check it out this evening...Preciate it!
Senderos...what was your take on the presentation? I have not had a chance to listen to it. Was there an update on the timeline for the bladder trial which should have data later in the year?
Thanks in advance!
Grabbed a starter position here today!
Sold LJPC 500 @ 18.25
Sold LJPC 150 @ 18.345
From 650 shares @ 8.84 avg!
106.6% return!
OT: Just got it through! Thanks for your help.
Sold LJPC 500 @ 18.25
Sold LJPC 150 @ 18.345
From 8.84 avg! 106.6% return!
OT: Is there a particular way to trade in after hrs trading? I have etrade and have placed a limit order but it never filled. TIA
LJPC...many thanks to Sheff and others on the board here. I bought and sold once with a 12% profit. I re bought last Thursday at an $8.84 avg for 650 shares and held through results. I will sell in the morning only because the 3-day rule etrade has on funds clearing and my acct. is not setup as a margin yet. I will post that percentage gain once the sell goes through.
Thanks again!!!!
My bet is here is because of Baker Bros and other inst. investor interest. I don't think they would put money here unless they liked the trial design.
AIMO of course!