I assume they would run clinical trials on animals and work up to the monkey. If rat cells worked in them and they could figure out the science that makes them safe, it would likely make it to an FDA trial. I agree with your #2.
We mammals all come from the same type cells - STEM CELLS... not till they start differentiating do we become different animals. Again my thought is these cells are so primitive they don't trigger an immune response. I could be way off base. Just thinking outloud.
The xenogeneic cells in this case human to rat was required because the FDA wanted to see that the exact line of cells to be used clinically were safe. (My understanding) It could be the primitive nature of the stem cell is so primitive it does not have the ability to be detected as foreign in most mammals. You pose a good question because if rat cells work in humans a cheap source of cells would be readily available and not require human volunteers.
Investors know that animals that received intravenously administered MAPCs showed a decrease in the size of the damaged area of the brain compared to animals that were not given these cells after an Ischemic Stroke. Investors also know they limit damage to a greater degree than MSCs. We know the MAPCs reduce inflammation and stimulate self-repair within the brain and this is thought largely due to the interaction with splenocytes. Investors know that when injected directly into the brain MSCs in a 2005 study conducted in Korea that after a year it appeared as no evidence existed as to improvement after stroke, probably proving that's not the best route of administration. That probably also proves the role of the splenocytes.
Investors know stroke is the second leading cause of death worldwide and a major cause of disability. Investors know that back in 2012 Athersys said the stroke market represents a commercial opportunity of more than $15 million.
Investors know one study researchers observed that intravenous administration of MultiStem one day after a stroke resulted in a substantial reduction in brain tissue loss 28 days post-stroke. In the preclinical model of stroke used in the study, animals that received treatment with MultiStem versus placebo showed statistically significant outcomes.
Investors know that Costantino Iadecola, MD, professor of neurology and neuroscience at Weill Cornell Medical College, noted that the pathobiology of stroke can be reproduced effectively in animal models.
Investors know a recent article titled "Setting the bar in stroke care: Landmark medical trials put Erlanger in forefront of research" that contained the following quote "We've seen some results that have been very impressive. The thing that's impressed me the most is the improvement at day 30". Seems to have been a positive slip of the tongue.
Investors know a lot !!
Thumbs up to that my friend :-)
I know you're just keeping it real and you've added balance to this discussion from an intelligent point of view. One I respect!
Mesoblast had a patent dispute with Osiris, just saying it was not a white flag as far as product not working. The deal took care of the dispute once and for all.
I understand all those points, yet, there they are (Mesoblast) smack dab in the middle of an FDA approved phase III trial. Athersys and Pfizer were supposed to head towards CD in phase III also.
I'd like to have those following this discussion use the BING search engine and type: mesoblast MSC trial phase III crohn's disease.
Then click on the PDF file Mesoblast Provides Update on Clinical...
Read that in full, Mesoblast has consciously decided to press on with phase III in IBD in the form of a Crohn's Disease trial.
More than meets the eye here with the ongoings using the MAPCs over at Pfizer. Not at all in disagreement with anyone just throwing things out there.
WST, Maybe you're correct. It could just be Pfizer did not have the knowledge that Mesoblast had when they advanced the MSC line. Lol... The fact does remain that Pfizer does have a competing drug in development that would not have them paying royalties and milestone payments.
I generally like what you have to say WST... just I've been around this game as long as you and I've seen many small companies pressured financially. Often to benefit big pharma or a competing interest with deep pockets. It's a dirty game in biotech. IMO
The scientific evidence is solidly behind this trial producing positive data for Athersys. It's Athersys who designed this trial and not Pfizer and investors will see on this go around a trial with no ulterior motives. Athersys has the timing of treatment down to the letter and that's probably why slips of the tongue have been made concerning medical personnel who've been administering either a placebo or MultiStem to patients in this trial. Slips like saying "We've seen some results that have been very impressive. The thing that's impressed me the most is the improvement at day 30". That's a pretty tell tale slip because only 50% "some" in the trial received MultiStem and it coincides with preclinical data that shows good improvement around day 28.
Obviously last years investors wanted a shot at the after data pie. Think they don't know something? Think again. Edison basically gave a price target of $15.40 inadvertently when you plug in the odds they used and the fact that the suggested targets given are pre-data release. Maxin upgraded to $9.... These targets are conservative and unfairly so because they are all cautious due to the Ulcerative Colitis outcome, a trial not even run or designed by Athersys.
I've always liked PSTI, it's just that investing in small biotech is already risky without placing my money in an Israeli company that may go down drastically if war erupts with the Palestinians.
Garnet only has one phase II trial and not in stroke. Athersys holds a superior position in number of patents held and Athersys is far ahead in development. Is it any wonder Athersys holds their hand close? This reminds me of the OSIR - Mesoblast patent fight. In past articles I've mentioned Athersys is well protected via patents and they are. Look at the web sites and you will see Athersys comes out on top.
The one phase II trial Garnet has ongoing is foreatment of Incisional Wounds. Again the courts found both cell types are NOT THE SAME this is good news. The fact Garnet believes in their cell that is very closely related to the MAPC is just more proof the MAPC phase II Ischemic Stroke trial should be a good outcome. The science is backing this trial.
Obviously I'm not WST, however, I'm weighing in on this one anyhow. The court found both cell types that Garnet Bio Theraputics uses and Athersys's MultiStem are indeed different cells. That means Garnet can't claim patent infringement against Athersys either. Since Garnet believes they have working cells that are similar to MultiStem... it's more proof MultiStem works IMO. This was a non event causing a nice buying opportunity. The IS data should be good and nothing has changed as far as what it is that's most important here an now to Investors.
Nice find... I'm sure you recall that in the earlier video they included his brain scan and the doctors seemed as though they'd not seen such rapid improvement before. Couple all this with comments about results that unintentionally may have spilled the beans in a different article and Gordie Howe's recover and you can draw your own conclusions. Mine say it's still speculative, however, with the overwhelming preclinical data and a qualified professional who tells us animal models can reflect human models for this indication and I'd say Athersys will have a huge success here. Stay tuned my blog will cover this in more detail in the coming days.
Agree if a lackluster enthusiasm heading into the UC data ran the share price over $4 ahead of data you know at least $6.50 is coming here. It should be more, however, some will be cautious because of the UC trial that actually did not have the science behind it like the IS trial does.
The relatively new but fast-developing field of research into the potential of stem cells modified using RNAi technology in cancer therapy shows once again how closely related both the disciplines are that is RNAi and Stem Cells. ALNY $96 and ATHX $2.23 currently.... this will change rapidly going forward. IMO
If not all that at least it is this:
Athersys is undervalued as compared to Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY). Synergies may exist in the future. Genetic modification of the stem cell using RNAi technology is certainly not out of the question and is already in exploration. Today the share price comparison shows a price tag of roughly $96 a share for Alnylam shares and $2.16 for Athersys shares. The expectation here is that in 2015 the valuation gap will slowly start to close.
It may be possible to use MAPCs as a source of stem cells for bioengineered small blood vessels. The observations made using ring constructs further substantiate the notion that MAPCs can differentiate into functional SMCs and suggest that very outcome.
MAPCs express in a temporally appropriate fashion SMC-specific transcripts and proteins and that such MAPC-derived SMCs display functional attributes similar to primary SMC populations, making them a good candidate stem cell population for developmental studies and tissue engineering.
A little secret - Targeting improves MAPC treatment of Inflammatory Bowel Disease. This was not known when Pfizer started the study. For example: Its been demonstrated a new method to coat MSCs with antibodies against addressins to enhance their delivery to the colon and thereby increase the therapeutic effectiveness.
Lots of information that looks like Athersys will indeed be the next ALNY... just look where that trades with no marketed product!
That's likely a bit low as Athersys went to over $4 on a sketchy UC trial. The IS trial has a lot of science backing it and should move Athersys shares to at Least $6.50 ahead of the data from numbers and odds of success I've calculated. Maxum seems to agree IMO