Tag Archives: amd

A new story about shareholder determination!

This is a VERY important article. As you-all may or may not know (and not necessarily, seeing as how there has been almost zero coverage), Astellas Pharmaceuticals is trying to buy Ocata. Now for a recap, for those who don’t know. Ocata, of course, holds the patents for stem cell-based treatments to a long list of incurable diseases. Their FDA-approved study for a cure for age-related macular degeneration has finished Phase I. AMD affects 220 million people in the world– yep, that’s right, 220 million– and is the number one cause of blindness in the developed world. A Phase I trial is only required to show safety. Ocata’s trial showed major improvement in over half the subjects, and stopped the progression of the original disease in all but one. These gains have been maintained for several years.

Most drugs currently for sale on the market for any purpose at all do not have results like this. Yep, I’m going to say it again; most approved drugs that have completed all phases of testing and can be bought at Walmart with your doctor’s prescription do not have a success rate like this. That’s not even mentioning the cures in earlier phases of testing, the ones for multiple sclerosis, rheumatoid arthritis, Crohn’s disease, lupus, chronic fatigue, and on and on and on. And… the company’s in danger of being bought out.

Not all of the retail shareholders agree with me on this, but given the insane unending demonizing of embryonic stem cell research in this country, I will be okay with seeing this go to Japan if that’s what it takes to make these cures happen. BUT… and it’s a big but… Ocata is giving it away for almost nothing. Now THAT, we can do something about. We are standing firm against the unacceptable offers that Astellas has made so far. And we’re getting some press at last! 🙂 Read and share!!
Small investors oppose Ocata sale; $379M offer deemed too low for drug ‘worth billions’

My fun trip to Casey Eye Institute this week, and the results…

So on Wednesday, I sat in the waiting room of Casey Eye Institute again, heart pounding, hands numb with terror where my fingers clutched at the wooden arms of the chair. (And if you think *that* sounds bad, then you should have seen me every time I had to go there four years ago!) I was surrounded by little old ladies in wheelchairs and inching along on walkers, their faces full of stubbornness and determination, with the flashing eyes and set lips of survivors. As usual, there were a couple of children, too. I tried to never look at the children, sitting quietly by their mothers, their faces hidden behind thick glasses, their faces filled with the weary patience of eight or nine year olds who have spent too much of their young lives in doctor’s offices and waiting rooms. There’s a lot more of this type of description in my memoir, but you know, I think we’ll stop there for the purposes of a blog post.

The point is, I went to Casey again, which I have to do twice a year. As usual, I would rather have been chased off a cliff by rabid wolves. But I sat in the chair while the retinal scanner went up and down my eyes; I sat in another chair while the cute and chirpy assistant stuck a dubious-looking metal thing meant to measure glaucoma right up against my eyeball, and I sat in the really fancy chair as I waited for Dr. Lauer to come in and interpret it all. (Hint: meditation mp3’s don’t really help in this situation.) And the news was…

(drumroll)

IT’S ALL GOOD!

Okay, maybe it’s not exactly *good*, but my vision is stable. There’s nothing new going on (which would mean new and bad; definitely not new and good.) The first doctor who looked at my retinas through that horrible bright slit lamp thingy was amazed that I hadn’t needed a new Lucentis injection since 2011. This really isn’t normal, and nobody seems to know why the first injections have held up so long. Of course, nobody ever exactly identified the original disease, either. 😛 So I was set free that day to skip out into the sunshine of the wide world outside OHSU, as people looked at me and wondered if I’d escaped from the psych ward.

But it did make me think about a few things.

Yes, this is good news. But there’s never any guarantee. I really do live one day at a time. And I know how lucky I am compared to a lot of people. Most younger patients are not helped by anti-VEGF drugs at all. It makes me a very impatient patient when I think about all the glowing news in the past few days,. Very little of the gushing is supported by fact. The much-ballyhooed treatment at Moorfields isn’t just in the first experimental stages. It’s also dangerous, invasive, scarring, risky to the survival of the retina, and extremely expensive. Why is there so much over-the-top excitement about it?? It’s exactly like the wet AMD treatment in Japan earlier this year, the one based on IPSC’s rushed to the clinic dangerously fast. The study was abruptly stopped, and nobody ever got a straight answer as to why. Other scientists have skirted the issue, showing a lot of professional courtesy in not confronting Dr. Takahashi, I’m sure, but not much regard for the rights of patients.

It’s hard to wait. But it’s good to know that we are waiting for something that works. That doesn’t set aside the issue of what may or may not happen in Phase II. But it does acknowledge the fact that we know that for the people in the Ocata study, the treatment to date has worked. I, for one, am over the excited gushing surrounding experimental treatments that haven’t even begun to do that much. Because we, the patients, deserve better than this. Everyone going through their own personal hell at Casey on Wednesday deserves better. I believe that we will get it. I have learned to wait, God only knows how. I haven’t been to any mountaintop, but I have seen a glimpse of it. We will get there, and we will do it together. So I say to everyone,… have faith, and hold on!

First Patient Enrolled in Ocata Therapeutics’ Phase 2 Study for Dry AMD Results from First Cohort Expected in the Second Quarter of 2016

Here’s the press release.
(STARES at today’s news)

*^()&)*(&)*(&)*( I DON’T EVEN.
(RUNS around yelling incoherently, but happily.)

INFINITE YAY.
THIS… this is what we’ve been waiting for. Ocata is officially now going to start Phase 2 of the AMD study.

There’s so much to be said here… it’ll have to get done later on… but for now… HAPPY. Just plain… happy. 🙂

My Amazing Powers of Predicting Disaster: Failure of the Takahashi Trials

!!!!!!
Ahem.

Well, the Japanese Takahashi trials with the induced pluripotent stem cells are turning out to be a dangerous failure. Read all about it here. Just as SOMEBODY predicted. Hmm… I can’t imagine who…

Anyway. The trials were stopped because, in the words of New Scientist: “ genetic mutations were discovered in the cells of the second trial participant. One of the mutations may carry a remote risk of cancer.” (Remote… oh really? This is the same publication that has carried gushing fan news about the IPSC trials since Day One. Of course, so have all the rest… but still, I wouldn’t trust a disclaimer like that as far as I could throw it.)

Hmm… .WHO predicted this failure last year? WHO posted these predictions multiple times all over the web, including Paul Knoepfler’s blog and investorstemcell.com? WHO said it was way too soon to rush into the clinical setting when there hadn’t been even a tenth of the number of animal studies that should have happened first? WHO held fast to this prediction, even when nobody agreed with her and nobody wanted to hear about it?

Could it be… ME??

Hint: the answer is yes.

I’m NOT posting the link to Randy Travis singing “I Told You So” again. This is actually beyond even what I dared to predict last fall for the IPSC trials. That’s it. There HAS to be a way to turn this amazing psychic power to predict disaster into something valuable… (hmmm)

Anise: (poring over a crystal ball while clients wait impatiently) I can tell you all the Powerball combinations that aren’t going to win.

Clients: Isn’t there a faster way?

Anise: No. But I can give you all 174 million losing number combinations, and you just have to go through them– wait– where are you going??

The point is that I knew the IPSC trials wouldn’t work. They were rushed to the clinic crazy fast because it was a chance for Japan and Riken to get the first clinical trial of IPSC’s underway. This represented a chance to save face after the STAP cell disaster last year. To tell you the truth, it’s not rocket science and is very easy to piece together. However, this kind of outcome is what I hoped wouldn’t happen. But it was always a possibility. I posted long, long threads about it in the past, and we really don’t need to go into all of it again here… suffice it to say that there are good reasons to have a lot more animal trials before jumping immediately and dangerously fast into clinical trials.

You know… this sounds horrible, but the failure of these trials will ultimately help Ocata a lot. One by one, the inferior and not-ready-for-prime time stem cell treatments are falling. Ocata’s treatment for AMD is the only one that continues to advance through all trials with flying colors. And since this is treatment I would need… well, I think I have the cred to say it!!

Also, it would have been good for that article to get Ocata’s name right. 😛 But you know… there’s good and bad in everything.

Continue reading

More Details About That South Korean Study

Here’s the link for the original South Korean article showing even more positive results for patients when the Ocata technique was used. This is a much smaller study with only four people, and I think the real value is that it supports the original results in the Lancet. There were two AMD and two SMD patients, and when I read the full article, I could see that all of them had improvements. Three were very significant (vision improved 50%, 100% (twice as good, and I can never remember if that should be 100% or 200%), and 1300% improvement– yes, vision that was thirteen times better than before the study!

The fourth person wasn’t considered to have significant improvement, but I’m not so sure that I would agree. Their vision went from being able to read one letter to two, and when your vision is that bad to start with, any improvement helps.

Anyway… I highly recommend reading the whole article. The complete pdf if available for free, which is usually not the case– so take advantage of it!

Treatment of Macular Degeneration Using Embryonic Stem Cell-Derived Retinal Pigment Epithelium: Preliminary Results in Asian Patients

New Ocata Press Release!

YES! These are the results we’ve been waiting for from CHA in So. Korea. They are great, and they 100% support the Lancet results from Ocata’s own trials. The thing that really impresses me about the CHA results is that just like Ocata’s, they were published in a peer-reviewed journal instead of being released through a company announcement. I have to say, I’m kind of over company announcements. (Remember when StemCells Inc did that??) Anyone can announce anything. I can announce that I just won Powerball. That doesn’t make it true! An article in a peer-reviewed journal is the gold standard.

Anyway, here’s a snippet, although you really need to go the link:
Continue reading

Ocata Therapeutics Successfully Completes Dosing in Phase 1/2 RPE Studies

Here’s a cogent, intelligent, and rational comment to the news below:
3458qu9fqu4589q3u-!!!!! OMG I DON’T EVEN. O.o.
This moment has been brought to you by the Department of Medical Miracles to Come. 🙂
THIS IS WHAT WE’VE BEEN WAITING FOR!!! It’s the OFFICIAL announcement! Ocata can now start the second trial! They have pivotal trial status from the European Medicines Agency! This means that they can start marketing the drug after the next trial is over! It would be the FIRST stem cell based drug approved since 1956! Yes, I really DO think that we need all of these exclamation points!!!

Capslock? What capslock? 😉

Ahem. Anyway, check it out. 🙂
Ocata’s Press Release on the Completion of Phase I/II of SMD Trials

Incredible News About Stargardt’s Cure

So, I was posting a summary for my book on the NaNoWriMo Facebook page, thinking that it sounded over the top… stem cell-based cures for horrible incurable diseases within 2-10 years, that kind of thing… well….

There’s no link for this, because it is insider info from shareholders who went to Ocata’s quarterly meeting in Boston, which was not open to the public. (There is a LOT about Ocata in the book– they’re the biotech company that just changed their name from Advanced Cell Technology.) Ocata is the company developing the first cure (or even treatment!) for age-related macular degeneration, a disease that slowly causes blindness for 30 million people in the U.S. and Europe alone. The interim published results for the clinical trials have looked great, but as far as when this treatment might actually come to market… it’s everybody’s guess.

But in the quarterly meeting… several attendees have all said the same thing. The drug already has orphan treatment approval for a genetic disease caused Stargardt’s, which has exactly the same effects and eventually causes blindness. But it attacks much younger people, including children as young as six. (Yep, six years old.) AND… the CEO of Ocata said that the drug will be available in the U.K. in 2018. We don’t have absolute confirmation of this yet. But it’s apparently what was officially said at that meeting.

One of the lines of thought on the forums is that the date might be earlier for AMD approval in the U.S, even quite a bit earlier if the drug is fast tracked here… we just don’t know. But this is INCREDIBLE!!!~ There has never ever been any kind of treatment for Stargardt’s before, and now there will be, and it will be STEM CELL BASED. As of now, that will be the first drug approved anywhere in the WORLD that is embryonic stem cell based.

YES! IT’S THE START OF A NEW ERA IN MEDICINE!!! And it will be in the book!
(sorry about the capslock…

Link to the Amazing msemporda’s Blog

There are a lot of stem cell blogs out there, some of them better than others… a LOT better. and some a lot worse. 😛 Paul Knoepfler’s blog is one of those at the head of the pack for sure, although I don’t always agree with everything he’s been publishing lately, especially the glowing, overly optimistic, heading-for-a-fall-IMHO coverage of Takahashi and her iPSC cell based RPE work in Japan. (You know, the one where they’re moving terrifyingly fast and using humans as guinea pigs about a zillion times faster than they should have…) But anyway. We all have our own opinions. 🙂

It’s also good to branch out. And that’s why I’m recommending this link to msemporda’s blog!

The Amazing Stem Cell Science Blog. THIS, I tell you, is an expert. Stem cell science, sector analysis, biotech company analysis, news… he has it all. And he’s somehow able to keep from rants…. I can’t do that, and I admit it… So check it out. 🙂

Yamanaka on the new iPSC trials for wet AMD in Japan. Part 1.

Head on over to Paul Knoepfler’s blog and check out hisYamanaka Interview on Clinical Use of Pluripotent Stem Cells.

I don’t know. I’ll be posting more about this tomorrow, but… suffice it to say right now that I wish I could get more excited about this new study with iPSC’s. I think they’re rushing wayyyyyy too fast to use these techniques on a human subject, especially when you look at all the pre-clinical problems and questions. And there were A LOT.

 

And I think we could have all lived without this quote:

 

At the same time, the ethical issues that hESC possess mean that as iPSC technology improves, hESC will be less needed. Still, iPSC is a new technology, and its safety and efficacy still needs to be confirmed.

 

Um, hello, EARTH TO DR. YAMANAKA. There ARE no “ethical issues.” Seriously, you don’t know about Robert Lanza’s blastomere technique, which doesn’t destroy the embryo?. And yep, no kidding that iPSC’s safety needs to be confirmed, much less their efficacy. Maybe we shouldn’t be blithely testing these cells on human beings right now.

 

That’s enough of a rant for today, but there will be more tomorrow!