Neuralstem: Some Encouraging, But Very Early, Information on Chinese Ischemic Stroke Trial Using NSI-566 Stem Cells (CUR, Buy, $2.59)
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:
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:
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.
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.
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.
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.
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 http://www.stroketrial.cn/news/html/?443.html
You 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.
Tagged as Chinese ischemic stroke trial, CUR, Neuralstem, Inc., NSI-566 + Categorized as Smith On Stocks Blog