Summary of the pipeline

A board to discuss future MS therapies in early stage (Phase I or II) trials.
Lyon
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dignan
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Post by dignan »

I'm done editing the phase 2 list, so it's time to add something, just for Bob.

I added Valomaciclovir (EPB-348) to the phase 1 list based on this press release:

http://www.epiphanybio.com/news/Press_R ... 3MAR09.pdf
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Lars
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Post by Lars »

Bob,
I think I'll take that bet. Too much info/study data leading that direction to discount it. We have done a impromptu survey in our group and almost all have a viral history be it EBV or Herpes. Dr Volmer (extreme guru of MS) of the Rocky Mountain MS Center, puts a lot of stock in this theory, so do I.
Hold onto that hat!
Be Well,
Lars
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dignan
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Post by dignan »

I added two studies to the phase 1 list: Linoleic Acid (omega-6) (University of Rochester) and Low Fat Diet (Oregon Health and Science University). I'm glad to see some non-drug treatments being tested.

http://www.clinicaltrials.gov/ct2/show/NCT00852722

http://www.clinicaltrials.gov/ct2/show/NCT00638196
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Post by LR1234 »

Something really confuses me about the low fat diet one.
It says that that fish is not allowed as part of the trial and that the diet will not be supplemented with Omega 3/6's via supplements.

A. I wonder why they have chosen to exclude fish.

B. I assume they will be giving the people in the low fat diet group measured amounts of rapeseed/ flaxseed oil or olive oil on their food.
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dignan
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Post by dignan »

LR1234, I don't know the answer with certainty, but I'm guessing they exclude fish / omegas because there is a chance that omegas have a positive influence on MS, so they are making sure the results of this study reflect the effects of a low fat diet, not omegas.
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Post by Lars »

Bob,
On a bit of a follow up, a Google search of HHV-6 and MS adds some interesting data on the viral connection. MS is triggered by something, I find it extremely plausible to consider this a candidate.
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Post by LR1234 »

Hi Dignan,
Any completion dates of the phase III trials? I am hoping some finish soon! Once they are published...if they are successful how long do the drugs take to get to the market?

L
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Post by dignan »

I'm adding Prolactin (Stem Cell Therapeutics / U of Calgary) to the phase 1 list based on a bunch of stuff. Thanks to Marcy for the tip.


From the Stem Cell Network:
Endogenous progenitor cell repair in multiple sclerosis (Core)
Investigators: Samuel Weiss (project leader), University of Calgary; Voon Wee Yong, University of Calgary; Jack Antel, McGill University; Luanne Metz, University of Calgary.

Project summary: Building on previously funded SCN research, this project includes basic research and a clinical trial to identify and test the role of prolactin, a pituitary hormone, in the repair of damaged myelin in patients with Multiple Sclerosis (MS).

Partners: Swartout Centre for MS Neuroprotection and Repair – Hotchkiss Brain Institute; Neuroscience Canada Foundation; Stem Cell Therapeutics Corp.

Benefits: The overall goal is to develop a novel therapeutic approach to treat MS patients.
http://www.stemcellnetwork.ca/projects.php


From Stem Cell Therapeutics (SCT):
SCT has substantial intellectual property relating to the use of neurogenic agents for treating demyelinating diseases such as multiple sclerosis (MS). Previous scientific investigations have characterized two potentially important therapeutic effects of prolactin on the CNS. In these published studies prolactin has been shown to act as both a neurogenic agent to increase the number of progenitor cells that mature into oligodendrocytes and as an agent that promotes remyelination of the brain in the presence of disease conditions. SCT was recently granted two key patents for the use of prolactin in neurologic diseases authored by Dr. Samuel Weiss from the University of Calgary and based on demonstrated insights into the effect of prolactin. Moreover, recent publications (Journal of Neuroscience, Feb. 21, 2007 ‘White Matter Plasticity and Enhanced Remyelination in Maternal CNS’ by Drs Yong and Weiss) strongly support and validate the concept that prolactin may represent a potential new therapeutic platform for the treatment of white matter injury, and an mpetus for a clinical program aimed at treating patients with multiple sclerosis. Successful completion of a preliminary non-clinical study undertaken by Dr Wee Yong at University of Calgary is expected to quickly evolve into a clinical program to demonstrate efficacy in patients diagnosed with multiple sclerosis. The results of this study are anticipated to be announced in early 2009, and the follow-on clinical study that will be lead by Dr Luann Metz at the University of Calgary is anticipated to begin in Q3 2009. This study is expected to be funded by an outside grant to the University of Calgary.
http://www.stemcellthera.com/pdf/SCT3Q08MD_A.pdf

A couple of other miscellaneous links:
- http://cnrp.marketwire.com/cnrp_files/2 ... 707sss.pdf
- http://cnrp.marketwire.com/cnrp_files/2 ... 09SSS1.pdf
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Post by Lars »

Dig,
I just noticed Tovaxin is still (or is back) on your list. Do you know something I don't?
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Post by dignan »

Lars, no, I don't know anything. I always figured Opexa would keep pushing to get somebody to buy them out. The last I read, the company has enough money to keep going until August. The latest data they've got I think actually achieved statistical significance on some measure (I think tovaxin was found to decrease company financial resources in a highly significant manner - p<0.000001).
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