One more Big Wow for ACTC's MSCs!!!!!

[Ceasar de Cuenca]

I was about to have dinner but I missed something that is very important!

All please note that ACTC has filed her patent covering the proprietary process of manufacturing covering both the hESC and iPS ways! With long telomeres and an almost infinite capacity to renew, and ideal as a Master Cell Bank!

Best,

Cuenca

[davea0828]

I was about to have dinner but I missed something that is very important!

All please note that ACTC has filed her patent covering the proprietary process of manufacturing covering both the hESC and iPS ways! With long telomeres and an almost infinite capacity to renew, and ideal as a Master Cell Bank!

Best,

Cuenca

I have read the slides about 5 times now, noting what was different between May and June, a single month. The Lancet report now has an extra line in it "Recorded functional visual improvements in both patients" that was not there before. I love the word "Recorded" and take it as absolute proof!!

The "Images of hESC-RPE transplantation site in SMD Patient" added "Demonstrate" survival and engraftment of RPE The injected RPE cells migrate to the desired anatomical location" just from May to now. More Proof!!!

The "Intellectual Property – RPE Program" slide and the "Price Justification" are both brand new and follows Ceasars comment about what ACT has and what its worth!!

The "Mesenchymal Stem Cells in Therapy" slide ands its added statement "An "off-the-shelf cellular drug ready for treatment of a wide range of inflammatory and autoimmune diseases", more what is there for the taking.

The "Adult Mesenchymal Stem Cells" slide with the additional statement "BUT: Replicative capacity is a big limitation for adult sources of allogeneic MSC therapies.", more proof that many have went after the wrong stem cells.

The entire "hESC/iPS – derived MSC" including the statement "Larger yield of MSCs - 33,000 fold greater yield relative to adult MSC" showing all the advantages to hESC's, ARE YOU KIDDING ME?? 33,000 TO 1 BETTER YIELD!!!!

And the killer "Animal Models" from the "Preliminary Data" slide. The two statements "hESC-derived MSCs substantially decrease and reverse disease conditions in autoimmune models." and "hESC-derived MSCs are far more potent than adult (BM) derived MSCs." take my breath away.

How is it the ACT slide presentation has changed so much in what, 30 to 40 days? The presentation is so much stronger than May's presentation.

I am damn excited over all this. I ask myself now, whats next, and WHEN? If the presentation changed that much in 30 to 40 days, I can only imagine what the next 6 months will bring.

Dave

[TORCH]

Great post Dave!

[davea0828]

Has anyone ever drank coffee from grounds where the water ran thru the grounds a second time? The thing you notice right away is how weak the coffee is. The color is wrong, the taste is wrong, it simply cannot be called coffee.

Thats how i see Adult stem cells vs hESC's of ACT. The Adult stem cells are watered down, nothing like the original hESC's.

I wonder how many people there are sitting in Board rooms realizing the millions and millions of dollars spent going down the wrong path. I can see them now, studing the slides, going over every single statement, graph, picture, trying to figure out what the impact is to their own trials and processes already in place.

Once, a long time ago, while I was programming in COBOL, thinking I was doing great with the entire process I went to visit a young Programmer at a small oil distributer in Seattle. He was programming in a 4GL language doing in 2 hours what I was getting done in 2 weeks. I broke out in a cold sweat realizing the end was coming using standard programing languages, not right away, but it was coming. It was a shock for me, one that I never ever forgot.

I suspect its happening to some very large companies right now, that same sinking feeling that your processes will be replaced, and all the income be replaced also.

Who makes the first move to re-aquire the lead position in Health Cure. We shall soon see.

Dave

[NOLAstemcell]

Unbelievable. Are we still looking at a $4 billion JV (although I guess that would be just for the eyes, right?) So perhaps $3 pps by the end of 2012 if all this continues to progress?

[davea0828]

Unbelievable. Are we still looking at a $4 billion JV (although I guess that would be just for the eyes, right?) So perhaps $3 pps by the end of 2012 if all this continues to progress?

NoLAstemcell,
You gotta believe something really really big is coming. It may not be 4 billion up front, but may be 4 billion over time, based on progress, on progress to market, and on the progress of a number of pre-selected programs, all that fit the JV partner to a Tee!!

Dave

[Skulbone]

It really makes these cheapie shares so much sweeter.

[john60]

It is not clear from the slides that it is working for AMD (Attachement). One of the slide mentiones that it is working for SMD.
This is my main concern with ACT and the science. Can some one re assure me on this issue...or Am I missing some thing. Lets remember that the market is mostly AMD...SMD is way too small to even justify current market cap?????

[jckrdu]

Unbelievable. Are we still looking at a $4 billion JV (although I guess that would be just for the eyes, right?) So perhaps $3 pps by the end of 2012 if all this continues to progress?

Below is my opinion only.....

I like the new slide deck and posted on other threads that I felt the deck was revamped/fine-tuned to speak to the institutional investors and potential JV partners. Matt Vincent's comment about ICELL's detective work and the potential impacts on deal making was also interesting.

However, my crystal ball says we still won't see a multi-billion dollar JV for the RPE program until ACTC starts generating Phase II efficacy results. Just because MV made a comment about deal-making and the slide deck was updated does not mean a massive RPE JV is imminent. IMO, ACTC is just showing their cards a little bit more as they go to these conferences, and is telling the institutions and potential partners exactly what they have, and the value of those cards. That's great, but a massive JV deal is still a bit farther down the road IMO.

I do think we'll see the China JV any time, and no later than end of 2012.

It is happening .... a little more patience is what we need.

[fred1947dy]

Why did slides only talk about 2 patients when 7 patients have been injected.

[jckrdu]

Why did slides only talk about 2 patients when 7 patients have been injected.

Hey Fred - Not to take over for Ceasar, but he's either still sleeping on the west coast or at the gym... so my 2 cents....

IMO, ACTC will release the results for cohort-1 SMD (3 patients) and cohort-1 AMD (3 patients) in a more strategic way when they believe the timing is right. Based on when the injections happend, I believe the SMD results for cohort-1 are available now, and AMD available in late June/July.

When they release this news, it will be a significant event.... as it will validate the early results of the first 2 patients. ACTC will show they went 6 for 6.... it will be evident that the first 2 patients was no fluke. I'm glad ACTC is waiting to release the "validation" news at the appropriate strategic time.

[Ceasar de Cuenca]

Hey Fred - Not to take over for Ceasar, but he's either still sleeping on the west coast or at the gym... so my 2 cents....

IMO, ACTC will release the results for cohort-1 SMD (3 patients) and cohort-1 AMD (3 patients) in a more strategic way when they believe the timing is right. Based on when the injections happend, I believe the SMD results for cohort-1 are available now, and AMD available in late June/July.

When they release this news, it will be a significant event.... as it will validate the early results of the first 2 patients. ACTC will show they went 6 for 6.... it will be evident that the first 2 patients was no fluke. I'm glad ACTC is waiting to release the "validation" news at the appropriate strategic time.

Hi Jckrdu,

Thanks for your help.
You are correct.
Also, I snoozed late today.

Cuenca

Cuenca

[mar-cell]

It is not clear from the slides that it is working for AMD (Attachement). One of the slide mentiones that it is working for SMD.
This is my main concern with ACT and the science. Can some one re assure me on this issue...or Am I missing some thing. Lets remember that the market is mostly AMD...SMD is way too small to even justify current market cap?????

If I remember well, Gary said that they saw a "similar trends " in both indications. That's the only thing so far which leads me to believe that the AMD trial is going fine...

Edited : from the London conference slides : "•Similar trends observed for latest AMD and SMD patients"

[tradeup]

Hey Fred - Not to take over for Ceasar, but he's either still sleeping on the west coast or at the gym... so my 2 cents....

IMO, ACTC will release the results for cohort-1 SMD (3 patients) and cohort-1 AMD (3 patients) in a more strategic way when they believe the timing is right. Based on when the injections happend, I believe the SMD results for cohort-1 are available now, and AMD available in late June/July.

When they release this news, it will be a significant event.... as it will validate the early results of the first 2 patients. ACTC will show they went 6 for 6.... it will be evident that the first 2 patients was no fluke. I'm glad ACTC is waiting to release the "validation" news at the appropriate strategic time.

Agreed. Additionally, the complete Cohort 1 data for SMD and AMD should add the following to ACT's preliminary results in The Lancet:

1. Compelling evidence to help rule out the Placebo effect. Notably in the AMD patient(s).
2. Safety and tolerability beyond the initial 4-months reported. There was a justifiably cautious tone with only 4-months safety data - despite the argument that within days/weeks any rejection or tumorigenicity would be noticeable. Longer-term the better. Question is, will ACT wait to release results until one full year after the first patient of each trial was injected?

I'm also assuming that later stage Cohorts will provide an even more compelling body of results:

1. Higher dosage + multiple injections/blebs = greater survival %. Increased visual rescue.
2. Earlier-stage patients -- where a consensus for visual improvement can more easily be reached.
3. Earlier-stage patients -- more Bruch's membrane present for RPE to attach and engraft to; rods and cones in a more repairable state.
4. Improved Imaging technology -- more compelling anatomical evidence of visual improvement.

[mar-cell]

" Compelling evidence to help rule out the Placebo effect. Notably in the AMD patient(s)."

In My opinion,this is what we need to conclude a JV without leaving "billions of dollars of the table".

[jckrdu]

" Compelling evidence to help rule out the Placebo effect. Notably in the AMD patient(s)."

In My opinion,this is what we need to conclude a JV without leaving "billions of dollars of the table".

A couple of more points about the results in the Dry AMD patients... some will be repetitive:

1. ACTC has stated that the 1st patient's (Sue Freeman) visual acuity has been sustained at 10 months, and that the other Dry AMD patients treated are following the same trend. So, IMO.... it's reasonable to assume that the treatment is working in late-stage Dry AMD patients at the lowest dosage.

2. Why no Evidence of Engraftment in Dry AMD? - Lanza stated that ACTC got lucky with the SMD patient as Dr. Schwartz just happened to be able to find RPE cells in one particular area where he was specifically looking. Lanza charaterized this as a lucky find that ACTC was then able to disclose in the Lancet. With the Dry AMD patient, while they did not have the same luck in finding the newly injected RPEs, IMO they are there. Also, in a subsequent conference call, it was either Matt Vincent or Lanza that stated it was very very difficult to discern the original RPE from the transplanted RPE.

IMO, the bottom line is that the therapy is working for the Dry AMD patients, and one day soon ACTC will be able to provide tangible proof that the RPE cells have engrafted. The additional empirical evidence of engraftment is that the untreated eye in Sue Freeman has returned to its pre-surgery level of visual acuity.

Informed people at ICELL have this information ahead of everyone else.

[mar-cell]

A couple of more points about the results in the Dry AMD patients... some will be repetitive:

1. ACTC has stated that the 1st patient's (Sue Freeman) visual acuity has been sustained at 10 months, and that the other Dry AMD patients treated are following the same trend. So, IMO.... it's reasonable to assume that the treatment is working in late-stage Dry AMD patients at the lowest dosage.

2. Why no Evidence of Engraftment in Dry AMD? - Lanza stated that ACTC got lucky with the SMD patient as Dr. Schwartz just happened to be able to find RPE cells in one particular area where he was specifically looking. Lanza charaterized this is a lucky find that ACTC was then able to disclose in the Lancet. With the Dry AMD patient, while they did not have the same luck in finding the newly injected RPEs, IMO they are there. Also, in a subsequent conference call, it was either Matt Vincent or Lanza that stated it was very very difficult to discern the original RPE from the transplanted RPE.

IMO, the bottom line is that the therapy is working for the Dry AMD patients, and one day soon ACTC will be able to provide tangible proof that the RPE cells have engrafted. The additional empirical evidence of engraftment is that the untreated eye in Sue Freeman has returned to its pre-surgery level of visual acuity.

Informed people at ICELL have this information ahead of everyone else.

Your assumptions are probably right, but most of the information you are referring to has only been disclosed verbally during some conferences. It has to be revealed in a more official manner if we want to convince those who still doubt about our treatment.

[jckrdu]

Your assumptions are probably right, but most of the information you are referring to has only been disclosed verbally during some conferences. It has to be revealed in a more official manner if we want to convince those who still doubt about our treatment.

Mar-Cell - Agree. For example, unless you were on the conference call when Rabin allowed Matt Vincent to disclose that Sue Freeman's untreated eye had returned to the pre-surgery level of visual acuity, you would not know about it. ACTC is letting out tidbits to shareholders to let us know everything is happening as expected with regard to the results, but they're waiting to officially release the news at a more strategic time.

Now: Interesting initial results for 2 patients, but one we're not sure about... and who knows if the improvements will last.

Sometime in 2012: Initial results validated in 4 more patients. Placebo effect definitively ruled out via vision in untreated eye. Results sustained for a year after treatment in the first 2.

[jckrdu]

Agreed. Additionally, the complete Cohort 1 data for SMD and AMD should add the following to ACT's preliminary results in The Lancet:

1. Compelling evidence to help rule out the Placebo effect. Notably in the AMD patient(s).
2. Safety and tolerability beyond the initial 4-months reported. There was a justifiably cautious tone with only 4-months safety data - despite the argument that within days/weeks any rejection or tumorigenicity would be noticeable. Longer-term the better. Question is, will ACT wait to release results until one full year after the first patient of each trial was injected?I'm also assuming that later stage Cohorts will provide an even more compelling body of results:

1. Higher dosage + multiple injections/blebs = greater survival %. Increased visual rescue.
2. Earlier-stage patients -- where a consensus for visual improvement can more easily be reached.
3. Earlier-stage patients -- more Bruch's membrane present for RPE to attach and engraft to; rods and cones in a more repairable state.
4. Improved Imaging technology -- more compelling anatomical evidence of visual improvement.

Hey Tradeup - Another question is... will ACTC have the Lancet do a follow-up study so we have peer-reviewed results for the first 6 patients?

It may take a little more time, but I hope they do elect to have the results peer-reviewed to provide official validation. Either way, I think we'll see the validation results sometime in 2012.

If we can get the SEC lawsuit and Aronson/Gorton behind us without too much damage, the pps could surprise a lot of people by the end of 2012.

[Peter Vaguely]

Hey Tradeup - Another question is... will ACTC have the Lancet do a follow-up study so we have peer-reviewed results for the first 6 patients?

It may take a little more time, but I hope they do elect to have the results peer-reviewed to provide official validation. Either way, I think we'll see the validation results sometime in 2012.

If we can get the SEC lawsuit and Aronson/Gorton behind us without too much damage, the pps could surprise a lot of people by the end of 2012.

I am quite certain that there will be another paper submitted to the Lancet, by Schwartz et al, for further peer review. Remember, the Lancet didn't do the study. The Lancet does a peer review of the report and then elects to publish. As the first was entitled: "Embryonic stem cell trials for macular degeneration: a preliminary report," I would be surprised if there wasn't a follow up.