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Post by JHam on Jul 16, 2014 14:15:03 GMT
Neuralstem, Inc. is a development-stage company focused on the development and commercialization of treatments for central nervous system disease based on transplanting human neural stems cells and the use of small molecule drugs. The Company has developed and maintains a portfolio of patents and patent applications that form base for its research and development efforts in the area of neural stem cell research. The Company's focus is the development of methods to generate replacement cells from neural stem cells. During the year ended December 31, 2011, the Company was selected as the primary subcontractor for the United States Department of Defense (DOD) contract to develop human neural stem cell technology for the treatment of cancerous brain tumors. The Company commenced work on the project in May 2011.
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Post by dayanand33 on Aug 6, 2014 0:28:27 GMT
FINAL PATIENT TREATED IN NEURALSTEM PHASE II ALS STEM CELL TRIAL GERMANTOWN, MD, August 4, 2014 -- Neuralstem, Inc. (NYSE MKT: CUR) announced that the final patient was treated in its Phase II trial using NSI-566 spinal cord-derived neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The multicenter Phase II trial treated 15 ambulatory patients in five different dosing cohorts. The first 12 patients received injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function, in escalating doses ranging from five injections of 200,000 cells per injection, to 20 injections of 400,000 cells each. The final three patients in the trial received both cervical and lumbar injections, for a total of 40 injections of 400,000 cells each, or a total of 16 million cells transplanted. In contrast, the final three patients in the Phase I trial received the maximum 15 injections of 100,000 cells each, for a total of 1.5 million cells. The trial will continue until six months past the final surgery, at which point the data will be evaluated. “We are all extremely pleased to have completed the transplantations in this historic Phase II trial,” said principal investigator, Dr. Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. “By early next year, we will have six-month follow up data on the last patients who received what we believe will be the maximum safe tolerated-dose for this therapy. We look forward to seeing what the data tell us about safety and efficacy of this approach. It is also worth noting that we will have completed this Phase II trial within a year, roughly. I would like to thank Dr. Parag Patil, and my collaborators at Emory, Drs. John Glass and Nick Boulis, and at Mass General, Drs. Merit Cudkowicz and Larry Borges, for helping us reach this goal.” Dr. Feldman is an unpaid consultant to Neuralstem. “The completion of Phase II of this important clinical research program is a major milestone, demonstrating that patients can tolerate the transplantation of high doses of cells and multiple spinal cord injections,” said site principal investigator, Jonathan D. Glass, MD, Director of the Emory ALS Center. “From both a clinical and scientific perspective, I think we are now ready to move forward toward a true therapeutic trial to test the efficacy of this surgical approach for slowing the course of ALS.” “We would like to express our thanks to all of the doctors and medical staff who made this possible, as well as the patients and their families. Without their bravery, none of this would have happened,” said Karl Johe, PhD, Neuralstem’s Chairman of the Board and Chief Scientific Officer. “With this landmark trial, the first to transplant stem cells in this volume and through so many injections along the length of the human spinal cord, we hope to establish the dose that is both safe and which may be optimal for treatment. We are excited about the collection and analysis of the final data and look forward to advancing to our next trial.” 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 Phase II clinical trials for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s disease, concluded final surgeries in July 2014. 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 approvals from the FDA and the Institutional Review Board of University of California, San Diego, 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 Phase Ia and Ib trials evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive disorder (MDD), and is expecting to launch a Phase II NSI-189/MDD study in 2015. 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
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Post by dayanand33 on Aug 10, 2014 15:06:10 GMT
10Q June 30 2014. A nice summary in the press release. It can serve as handy reference a few months down the line GERMANTOWN, Md., Aug. 8, 2014 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) today reported its financial results for the three months and six months ended June 30, 2014 and provided a business and clinical update.
"We are pleased to report that 2014 has already seen the company achieve several major milestones. In late July, we completed the last of the surgeries in the NSI-566/ALS Phase II trial. Each of the patients in the final cohort have received a total of 16 million NSI-566 neural stem cells, through 40 surgical injections of 400,000 cells per injection. The trial will conclude after an observation period of six months," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer.
"Our FDA-approved NSI-566 Phase I trial to treat chronic spinal cord injury (cSCI) is scheduled to commence in the coming weeks at the University of California, San Diego, School of Medicine, following approval by UCSD's Institutional Review Board during the second quarter," said Dr. Johe. "The open-label, ascending-dose study of patients with thoracic spinal cord injuries utilizes the same proprietary spinal platform and floating cannula developed for the ALS trials, as well as the same NSI-566 spinal cord cells. Patients in this trial will have an American Spinal Injury Association AIS-A level of impairment (considered to be in complete paralysis) and will be between one and two years post injury. The trial is generously supported by, and will be conducted in its entirety at, UCSD under the guidance of Principal Investigator, Joseph Ciacci, MD."
Dr. Johe continued: "During the second quarter, the company achieved another major milestone when data from the Ib trial of our neurogenic small molecule compound to treat MDD was presented at two prestigious academic conferences held in June: the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, and the International College of Neuropyschopharmacology (CINP) Annual Meeting. The extremely robust NSI-189 Phase Ib data showed statistical significance; and clinically meaningful improvement of both depression and cognitive symptoms in the active therapy patients, compared to placebo across all clinical measurements. Further, the improvements persisted eight weeks after 28-day treatment stopped.
"We believe the biomarker data (quantitative EEG), which was included in the CINP conference presentation, confirms that NSI-189 is affecting key circuitry common in both mood control and cognition, involving hippocampal neurogenesis and synaptogenesis," added Dr. Johe. "Combined with the significant clinical improvements of the patients, these findings validate our hypothesis that NSI-189 stimulates the neurogenesis of hippocampal stem cells, altering the fine structures within the hippocampus in a manner that is long-lasting. We are encouraged that NSI-189 may be affecting the physical structure of the human brain in these depression patients and may modify progression of cognitive impairment diseases, as well.
"With such positive data supporting this novel neurogenesis-based platform, we and fellow investigators, including lead study author, Dr. Maurizio Fava, Executive Vice Chair, Department of Psychiatry, Executive Director, Clinical Trials Network and Institute, Massachusetts General Hospital, are preparing the Phase II trial application. We plan to launch a multi-site NSI-189/Phase II MDD study late in the first quarter of 2015. This next clinical trial will test two doses (40mg once a day and 40mg twice a day), along with a randomized, double-blinded, placebo control group, in approximately 150 patients with confirmed diagnosis of recurrent MDD, with the aim of confirming these extremely promising results in a larger clinical setting," concluded Dr. Johe.
"We closed the second quarter of 2014 with a cash position of nearly $30 million, which gives a solid foundation to execute on the company's business plan through mid-2016," said Richard Garr, Neuralstem's President and CEO. "As Neuralstem's products advance in the clinic in both cell therapy and neurogenic pharmaceuticals, we are building the infrastructure necessary to accelerate our programs towards NSI-566 and NSI-189 commercialization. To that end, my fellow Directors and I were pleased to welcome Sandy Smith as a Director during the second quarter. Sandy is the former President, International Group, and Executive Vice President of Genzyme Corporation. His experience directing global commercialization for one of the world's most successful rare disease companies, where he was directly responsible for launching 12 new products in diverse therapeutic areas, will prove invaluable as we take the company to the next level. Sandy's appointment follows that of Catherine Sohn, PharmD, who spearheaded global commercialization at GlaxoSmithKline, one of the world's largest pharmaceutical companies. We are already benefitting from this level of expertise and experience being added to Neuralstem's Board. We are extremely pleased to have Sandy's and Cathy's guidance during this time of pivotal inflection points for our product development in both the Company's cell therapy and small molecule programs.
"During this past quarter, we further strengthened our global IP portfolio with the issuance of a neurogenic small molecule patent, validated in 34 countries, by the European Patent Organisation. We also received notice of issuance of the second U.S. patent for the floating spinal cannula surgical device used in cell therapy. This brings our total patents to 87 issued and 59 pending," said Garr.
"Dr. Johe and I would like to acknowledge with deep gratitude the brave patients and their families and caregivers who are allowing this breakthrough cell therapy and novel neurogenic drug advancements in the clinic. We also thank our exceptional collaborators, among them: NSI-189/psychiatric/small molecule trial consultant, Maurizio Fava, MD, NSI-566/ALS principal investigator, Eva L. Feldman, MD, PhD, and NSI-566/cSCI lead collaborator, Martin Marsala, MD, PhD. We also want to acknowledge the leading institutions that serve as sites for this ground-breaking work, including the University of Michigan, Emory University, Massachusetts General, and University of California, San Diego," concluded Garr.
Second Quarter Clinical Program and Business Highlights
In June, Neuralstem's NSI-189/MDD Phase Ib data was reported at the annual meetings of both the American Society of Clinical Psychopharmacology (ASCP), and the International College of Neuropyschopharmacology (CINP).
"A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation Study Evaluating the Effects of NSI-189 Phosphate, A Neurogenic Compound, in Patients with Major Depressive Disorder (MDD)," was presented at the ASCP Annual Meeting by Marlene Freeman, MD, Medical Director, Clinical Trials Network and Institute, Massachusetts General Hospital, and Associate Professor of Psychiatry, Harvard Medical School. Data showed a clinically meaningful reduction in cognitive and depressive symptoms across all measures in depressed patients on NSI-189 active therapy against the control group, continuing for the duration of the trial, eight weeks after the 28-day treatment had stopped. A large effect was reported in all four scales employed in the study that are commonly used to assess clinical levels of depression and improvement: Montgomery-Asberg Depression Rating Scale (MADRS), Clinician Global Impression–Improvement (CGI-I), Symptoms of Depression Questionnaire (SDQ), and Cognitive and Physical Functioning Questionnaire (CPFQ). Based on the results, the investigators concluded that a neurogenesis-based platform could identify promising new treatments for MDD. "Effects of NSI-189, a neurogenic compound, on quantitative electroencephalography (qEEG) in patients with major depressive disorder (MDD) during a phase 1b randomized, double-blinded, placebo controlled, multiple ascending dose study" was the title of a poster presented by [Brett English, PharmD, PhD, Adjunct Assistant Professor at USC School of Pharmacy and Senior Director for Scientific Affairs at PAREXEL] at the CINP Annual Meeting. The NSI-189/MDD Phase Ib qEEG data showed significantly increased brain wave patterns in the hippocampal region of the brain, and increased electrical coherence in the prefrontal cortical region, which is a pro-cognitive signal. Researchers concluded that these electrophysiological changes are consistent with the neurogenic hypothesis of the drug mechanism, which involves long-term structural changes in the hippocampus. In June, Neuralstem received issuance of EPO Patent # 2470182 (Synthesis of a Neurostimulative Piperazine), that was validated in 34 countries: Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Monaco, Macedonia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia and Turkey, for a total of 35 European patents.
In June, Neuralstem shares were added to the broad-market Russell 3000® Index. Annual reconstitution of Russell's U.S. indexes captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization. Membership in the Russell 3000, which remains in place for one year, brings automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes.
In May, Sandford Drexel Smith was appointed to Neuralstem's Board of Directors. Mr. Smith is the former President, International Group, and Executive Vice President of Genzyme Corporation. As President of the International Group, Mr. Smith opened markets in Latin America, China, India, Russia and Eastern Europe, establishing more than 45 offices worldwide, and was responsible for the launch of 12 new products in diverse therapeutic areas. He grew Genzyme's international business to $3.1 billion, or 60% of the company's total revenues. In 2011, Genzyme was acquired by Sanofi, one of the world's largest healthcare companies.
In May, Neuralstem's President and CEO, Richard Garr, presented a talk entitled, "Sustainable Growth of Regenerative Medicine: Ensuring Long Term Development and Patient Access to Transformative Cell Therapies," at the World Stem Cells & Regenerative Medicine Congress, in London, UK.
In April, the FDA-approved NSI-566 Phase I trial to treat chronic spinal cord injury (cSCI) was approved to commence at the University of California, San Diego, School of Medicine by its Institutional Review Board. The open-label study will enroll patients with thoracic spinal cord injuries who have an American Spinal Injury Association AIS-A level of impairment (patients who are considered to be in complete paralysis) and are between one and two years post injury. NSI-566/cSCI patients will also receive post-surgery immunosuppressive therapy as tolerated for three months.
In April, NSI-566/ALS Principal Investigator, Eva Feldman, PhD, MD, presented published Phase I data at the Keystone Symposia, "Engineering Cell Fate and Function." Dr. Feldman took part in a workshop, organized in collaboration with California Institute for Regenerative Medicine, called "Clinical Progress for Stem Cell Therapies."
In April, the United States Patent Office issued Patent #8,708,962, the second U.S. patent for the floating spinal cannula and method of use, to which Neuralstem holds exclusive license.
Second Quarter Financial Results
For the three months ended June 30, 2014, the Company reported a net loss of approximately $6,751,000 or $0.08 per share, compared with a net loss of approximately $6,252,000 or $0.09 per share, for the comparable 2013 period. The increase in net loss was due primarily due to a $278,000 increase in operating loss due to an increase in legal, consulting and professional fees included in our general and administrative expenses related to patent, litigation and other corporate matters. This is coupled with a $227,000 increase in other expenses primarily due to a $705,000 increase in non-cash expense related to modifications of certain stock purchase warrants, partially offset by $250,000 of income from a legal settlement in the current period and prior period including a $188,000 non-cash expense for the change in fair value of our warrant liability.
For the six months ended June 30, 2014, the Company reported a net loss of approximately $12,670,000 or $0.15 per share, compared with a net loss of approximately $9,842,000 or $0.14 per share, for the comparable 2013 period. The increase in net loss was due primarily due to a $2,561,000 increase in operating loss comprised of a $1,878,000 to an increase in non-cash stock based compensation mainly due to a consultant achieving a performance based milestone which resulted in a term extension of certain common stock purchase warrants along with a $390,000 increase in legal, consulting and professional fees included in our general and administrative expenses related to patent, litigation and other corporate matters. This is coupled with a $268,000 increase in other expenses primarily due to a $343,000 increase in interest expense due to the prior year only including 3 months of expense related to our March 2013 debt issuance; a $152,000 increase in non-cash expense for the change in fair value of our warrant liability partially offset by $250,000 of income from a legal settlement in the current period.
Our cash, cash equivalents and short-term investments on hand was approximately $30,232,000 at June 30, 2014, compared to $16,846,000 at December 31, 2013. The increase of approximately $13,386,000 was primarily due to our raising net $18.7 million through our January 2014 registered direct offering coupled with approximately $1.7 million from the exercise of certain common stock purchase warrants and options partially offset by cash used in our operations.
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Post by stemman on Sept 6, 2014 16:51:34 GMT
What is the group's opinion on the following: A Closer Look At Neuralstem's ALS Treatment - Forbes "This is a complicated operation (recent video), one requiring special training for the surgeon, as it involves exposing the patient’s spine and using a custom delivery system that has to counteract the subtle movements of the patient, even under anesthesia, to avoid damaging spinal nerves. According to CEO I. Richard Garr, these are the world’s first intraspinal injections, directly into the gray matter, not the spinal cavity or spinal fluid." (my highlights) This reminds me of the Coffey scaffold implant vs. ACT's injection (complexity-wise). If both CUR and BCLI ALS treatments get approved, assuming both show similarly good efficacy, wouldn't the easier, quicker, more patient-friendly, lower-risk, less expensive option be more likely to prevail? I think Neuralstem's treatment may have one advantage over Brainstorm's: if I understand it correctly, Brainstorm's treatment needs to be repeated (not sure how many times and how often). All-in-all, how would you rate CUR's chances to win over the patients and the insurers if both options were available? (I may cross-post this under BCLI.)
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Post by forthefuture on Sept 8, 2014 22:20:56 GMT
What is the group's opinion on the following: A Closer Look At Neuralstem's ALS Treatment - Forbes "This is a complicated operation (recent video), one requiring special training for the surgeon, as it involves exposing the patient’s spine and using a custom delivery system that has to counteract the subtle movements of the patient, even under anesthesia, to avoid damaging spinal nerves. According to CEO I. Richard Garr, these are the world’s first intraspinal injections, directly into the gray matter, not the spinal cavity or spinal fluid." (my highlights) This reminds me of the Coffey scaffold implant vs. ACT's injection (complexity-wise). If both CUR and BCLI ALS treatments get approved, assuming both show similarly good efficacy, wouldn't the easier, quicker, more patient-friendly, lower-risk, less expensive option be more likely to prevail? I think Neuralstem's treatment may have one advantage over Brainstorm's: if I understand it correctly, Brainstorm's treatment needs to be repeated (not sure how many times and how often). All-in-all, how would you rate CUR's chances to win over the patients and the insurers if both options were available? (I may cross-post this under BCLI.) Ease of administration could certainly play a part, but at this point in the game, there's still plenty of time for one or the other to differentiate based on efficacy data.
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Post by mycargoesfast on Jan 7, 2015 19:19:32 GMT
Caught this on the Yahoo boards today, all rumor but interesting none-the-less: smithonstocks.com/neuralstem-some-encouraging-but-very-early-information-on-chinese-ischemic-stroke-trial-using-nsi-566-stem-cells-cur-buy-2-59Neuralstem: Some Encouraging, But Very Early, Information on Chinese Ischemic Stroke Trial Using NSI-566 Stem Cells (CUR, Buy, $2.59) Posted by Larry Smith on Dec 18, 2014 • (0) Purpose of This Blog I received this e-mail communication from a SmithOnStocks subscriber who has a good insight into the Chinese drug market and drug development. This is the first report of any kind that I have seen on patient outcomes in the trial of Neuralstem’s Chinese trial of NSI-566 stem cells in ischemic stroke patients. He wrote as follows: “Larry, Hi. I stumbled upon a story about CUR’s stroke program in China today. The story was posted online on Oct 17 2014. It was written in Chinese about the final visit (the 4th visit) of the first patient enrolled in this program. I translated the abstract of this story and some key points below: Abstract: 一次性神经干细胞移植手术治疗9个月后,首例参与患者完全恢复独立行走及语言能力,并且持续数月保持改善状态。其余病人也有不同程度的改善。 9 months after one time transplantation of Neuralstem cells, the first patient fully recovered his ability to walk and speak. And these improvements lasted for months. Other patients expressed various degrees of improvements also. 北京军区总院附属八一脑科医院的医生,按照临床研究的预定方案,本周对参与中风临床研究的第一个病人,进行了神经干细胞移植手术治疗9个月后的第四次回访, 对病人进行了全面检查。结果表明,神经干细胞移植治疗,对这位原来病症较为严重的脑中风偏瘫患者,有很显著的疗效,并且这种效果在三个月前的前次检查初次显示后, 继续保持下来。按各项临床检测的诊断与判别,病人的各种功能恢复,与治疗前相比较,有50%甚至更好的改善。 Doctors from Beijing Bayi hospital conducted the 4th return visit for the first patient this week according to the trial design. The results showed that the transplantation greatly improved the patient who had had a relatively severe stroke greatly improved and the improvements last at least for 3 months. Various assessments, compared to pre-trial baseline, improved 50% or more. 神经干细胞移植的疗效在病人身上的直观表现,是其运动及语言功能障碍的显著改善。在做干细胞移植手术前,该病人需要家属搀扶才能来医院。 经过一次性神经干细胞的移植治疗,病人的肢体运动能力得到显著改善,至今其偏瘫一侧的肢体的功能已经有相当程度的恢复,达到能够完全独立行走、不需要任何人搀扶、协助的水平。 这次以及前一次来医院检查,他都是自己一个人坐公交车来的。 The most obvious relief from the cell transplantation is the patients’ improvement in the walking and speaking ability. Before transplantation, this patient has to be carried by his relatives to the hospital. After one time transplantation, the mobility of the patient’s limbs greatly improved. Though still a little paralyzed in one side of his body, the patient can now walk without ANY assistance. He himself without company took the bus to the hospital in this visit and in the last one 3 months ago. 对语言功能障碍的恢复,神经干细胞治疗效果更为突出、更加迅速地体现出来:在手术后几天内,病人自己就感觉语言障碍有明显改善(他手术前说话有很严重的障碍,每次想表达一下自己的意思,只能一个字、一个字地“蹦”出来)。一个月回访时,他说话的能力就有相当程度的恢复(他太太当时甚至“抱怨”他话太多了—对于一个患病已达一年之久、因为中风而导致的语言功能障碍而长期“有口难言”的人来说,一旦功能恢复就会常常要打开“话匣子”,是完全可以理解的)。现在该病人的语言能力已基本恢复,可以毫不困难地整段整句地说话了。目前这种语言能力的恢复也继续保持良好。 As to the speaking ability, the cell transplantation worked more prominent and even quicker. Several days after operation, the patient himself felt his ability to speak greatly improved (he had severe speech impairments and could only speak one word at a time to express himself). At the first month visit, his speech ability greatly recovered (His wife even complained he’s talking too much. It is understandable for a patient who had had a stroke and could hardly speak for more than one year, though). Now the patient’s speaking ability almost fully recovered. And this improvement also preserves well. 后续入组的病人,目前也有不同程度的改善。必须指出的是,中风偏瘫病人的脑组织损伤,常常是非常严重的、有时甚至是不可逆的。因此,以神经干细胞来修复这样的脑组织损伤,是个漫长、也许需要数年之久的长期过程。其最终的治疗效果,也会因为病人的具体情况的不同、脑组织损伤的程度不同、以及病人本身的个体差异,例如年龄、身体状况、是否有其它相关病症、是否积极参与康复治疗等等因素而不同。 Other patients experienced various degrees of improvements as well. We have to point out; brain injuries due to the stroke are generally severe and irreversible. Therefore, it may take a very long period of time, sometimes years, for the patients to recover. The ultimate outcome may vary according to the patient conditions, degrees of injury, patient diversity such as age, general health, other diseases, willingness to participate into the trial, etc. The remaining report is about the general description of the trial which we all know for a while. So I stop here. The link of this page is www.stroketrial.cn/news/html/?443.htmlYou may use google translate or other programs if you will.” My Thoughts on This Report Neuralstem has noted in response to questions that it appears to be seeing encouraging signs in the patients initially treated in the Chinese ischemic stroke trial. However, this is the very early “dose up” part of the trial. In the US, this would be called a phase 1b trial that treats patients suffering from the disease state as opposed to healthy volunteers. It is extremely early to be expecting or talking about efficacy. The main goal of the first 18 patients treated in this trial is to establish the maximum safe tolerated dose for the following part of the trial which will be equivalent to a phase 2/3 trial in the US. Investigators are, of course, measuring functional recovery. Investors generally are skeptical of data coming out of China and Neuralstem is especially sensitive to this issue. Hence, they are very cautious in talking about early results. Management would not comment to me on this report other than to say that stroke is a huge public health problem in China and one of the main reasons they have established a presence there. This report is intriguing but I am not urging any action based on this. Still, given the potential importance of this trial, it is something worth watching.
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