You won't be able to do that in North America or will you?Originally Posted by jsilver
You won't be able to do that in North America or will you?
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The enzyme is administered through micro-needles but the number of injections per area that would adequately cover the cord still needs to be worked out in a larger animal model. In our rat model we only administer a single injection at C4. When the viral vectors are perfected they spread much farther than regular ch'ase. Thus, perhaps only a single injection will be needed even in a larger animal per targeted area. The peptide is given systemically and can be administered for as long as needed. A critical adjunct to the therapy can be physical rehab or epidural stimulation.
No problem of doing these experiments in the US. We just need the cooperation of a university with a good primate facility.
It is nice to hear promising research going on, and even more nice to have the one administering it communicating with us! Thank you Dr. Silver and keep up the good work!
Dr. Silver,
Thank you for responding and engaging our community through this channel. I am excited about this peptide and the Ch'ase developments.
A few questions:
1) Can you give us an actual estimate for a timeframe when Ch'ase will start Human Trials. (I.e.: 6mo, 1yr, 3yrs, you cannot comment because of confidentiality or uncertainty, or a more in depth explanation than ISRT is developing a delivery method) People here and myself want hear a definitive answer.
2) Can you give us a time estimate on the peptide as well, assuming it is effective and safe?
3) You mentioned Acorda Therapeutics in the Q&A. Can you give us some of their reasoning for why they are sitting on a Ch'ase patent without pursuing human trials? Is there patent issues that ISRT are going to run into or are having that are hindering progression for their Ch'ase version? What is being done to prevent this story from repeating?
4) What can we advocate to the government and industry to help you and others expedite this research?
Thank's!
OK let me have a go at these but it is difficult to pinpoint an exact timeframe.
The major reason that chondroitinase has not gone to clinical trials is because there has not been compelling research showing that the enzyme by itself could restore robust function
at chronic stages following cord injury. With our new results I hope that this will stimulate the ISRT to move forward even more rapidly. However, they are a small foundation with limited resources.
You might wish to contact the ISRT and get a sense of their timeline. Their new delivery system of the enzyme should be completely proprietary to the inventors. The ISRT is my bet for the clinical future of chondroitinase.
Our peptide strategy has a ways to go. We need to move towards a therapy that works to restore function after chronic contusive injury and show efficacy and safety with a maximum tolerated dose study.
These challenging experiments are now in progress.
Dr Silver
Should your lab and ISRT manage to produce a combination therapy of your peptide and chase, how 'portable' would the treatment be? By that I mean, I am in New Zealand and so I'm wondering how easy would it be for neurosurgeons here to perform the procedure? Or would patients have to travel overseas to specific centers which specialized in that therapy?
Our strategy is relatively straightforward and easy to administer. It is minimally invasive so theoretically anybody could do this.
I don't mean this as antagonistic, although it may sound that way...Honestly, what are the differences between what you are proposing to do and what they already testing at the university of iowa state with dogs? A different compound?
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If I'm not mistaken, the addition of their peptide.
Large animal studies without PETA's influence .. 3-5 if they started tomorrow. Must get funding and talk a university into it ... 3-5 additional years? Human trials and money - another 10yrs?
I don't think these figures are way off.
Last edited by lynnifer; 02-19-2016 at 03:15 AM.
Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.
T-11 Flaccid Paraplegic due to TM July 1985 @ age 12
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