Okay, so I could explain a lot more details about this specific case, but for now, here’s the basic question.
Is there a typical length of time that a new drug tends to take to go through Phase 2 & 3 trials (after it’s past Phase 1)? Does anyone know? All thoughts appreciated!
Without knowing any more details, you’re probably looking at about a year (plus or minus 6 months) on average per phase (2 & 3) assuming no complications.
I’m not sure what you’re getting at, but if you go to the company’s website and click on “Investor Information” you might be able to find out more information. That’s where they’ll usually talk news regarding new drugs and how they’re progressing through the phases, when they expect them to get to the next phase, if there’s any hold ups etc…
Well… okay, HERE’S the part where y’all find out that I’ve obsessively studied every possible detail about this company and everyone in it for two years now. It’s Advanced Cell Technology.
They just got approval to put the last people in the cohort through the end of the Phase 1 trials. They’ll be meeting with their ophthalmology board in October, and there’s no reason why they shouldn’t be allowed to go through to the Phase 2 trials.
The thing is that THEY are certainly not talking about how long they expect those last 2 trials to take, and I can’t find accurate information about how long these usually take, on average. If it makes a difference, hundreds of millions of people desperately need this treatment, and it would be the very first effective treatment that has ever existed for these diseases (AMD and SMD, basically different types of macular degeneration.) There is no way to even begin to describe what this would mean to me. If I won the lottery, I would give every cent to this company to continue research and development. So I’m not exactly the most uninvolved observer here… I totally admit it.
They’re moving VERY slowly with this. From what I can tell, as of January of 2011 they discussed moving from animals to ONE patient and ramping up to 12 patients. In the PDF they’re still making references to individual patients (as opposed to ‘groups’). You need to be reading about thousands of people being tested before it hits the market.
If I had to guess…I’d guess this is at least 10 year away from hitting the general public.
I seemed to be oddly spot on with my 10 year guess.
The company has gone with the South Park Business plan of
1)Invent Something
2)???
3)Profit
But if you take a look at page 42 of their conference call from a few months ago, they have a 10 year plan to go from testing to being on the market in full force.
This report, from last year, says that P3 will be done in 2014 or 2015. That sorta kinda jives with the more recent report I linked to in the last report, but it’s common for that to happen.
One more thing, here’s another report, that tells me it’s going to be a LONG time. In October they’re going to start talking about Phase 2 trials, and this report also discusses bringing on two more people.
I see this drug uses stem cells, but I thought there was another drug that does this as well. I just remember Cramer having someone on his show and talking about having to inject something right into their eye and I know Cramer wouldn’t have the CEO of a penny stock on.
BTW, you (the OP) might want to get a Sharebuilder or ETrade account or just google ACTC once in a while. That’s their stock symbol. That’s going to be the best way you can get news, both good and bad about them. Virtually anytime their name is mentioned WRT something happening with that drug, investors want to know about it.
Yeah, I was going to mention that too, but there’s a lot of garbage out there too. This will help just bring in the actual news reports. It’s grab everything off their website, SEC filings, things from MotleyFool, and a handful of financial media outlets. It won’t, however, bring you all the garbage from the Yahoo financial message boards or tell you every time someone tried to pump and dump the penny stock on some skeevy corner of the internet.
So, I’d stand by just going to E*Trade, Sharebuilder, Seeking Alpha, Motley Fool etc and plugging in ACTC to grab news articles from time to time.
Have you ever used google alerts? There is a ‘best of’ feature that cuts down on the garbage considerably. You can also specify categories like news only.
Because I like to think POSITIVELY (positive? Positive-esque?), I’m going with 2015 for the Phase III trials. Drug companies certainly know just how much money could be made with this, and at least a hundred million people worldwide are suffering and losing so much quality of life without this treatment, so a lot of people have a lot of incentive to push things forward. The biggest problem that ACT has had with these trials (IMHO, anyway), is that it’s so hard to find older adults with AMD who can pass all of the necessary requirements to be in them. Everyone who was even in the pool of people they drew from was over 80 (per a retinal expert at Casey Eye Institute), and there are very few who do not have comorbid conditions by that point. I’m not completely sure how they’d ever get thousands of subjects-- they’d have to pull from the group of younger people with the rarer forms. But this would be a case for compassionate drug exemptions from the FDA if there has ever been one.
And, oh yes… As far as I know, there are no other drugs for… um… ocular injection that involve stem cell treatments. Avastin and Lucentis are the only current treatments, and they only have a real therapeutic effect for wet AMD (and a couple of very rare forms that are not age-related. That’s how I know about this…) And let’s just say that the procedure is actually worse to hear about than it is to have done. I will say no more.
ETA: Because of the editing time window, this has to be a separate post: the ten year plan (this doc )refers to the platelet project. Also, SMD and the rarer forms would have orphan drug status.
If I understand correctly, you yourself have AMD? Have you tried applying to be a test subject? It might be risky, but you WOULD get access to the treatment very soon.
Can’t give you much information here as I’m not an expert on the topic. But last January I was lucky enough to attend a lecture given by Nobel Prize winner John Gurdon, one of the world’s leading experts in stem cell research. When asked about the future of his branch of medicine, he said that ophtalmology was undoubtedly the area in which they were getting the best results, and where we should expect more new treatments in the coming years.
Thanks! It’s so great to know, and the people on this board are so smart…
But no, I didn’t exactly have AMD as such. I had a flareup of a very rare form, possibly something genetic, and it kind of mimicked AMD. At the time, I don’t think anyone at Casey (eye institute) actually thought that Avastin would work. (those treatments don’t do anything for the other types of MD, the ones that are not age-related. Some of those can even affect children… and I did see a few during the times I was there. I actually saw a baby. Let’s talk about something more cheerful now. On the whole, if you ever want to feel REALLY young, a retinal specialist’s office is the place to be. And it did work! And no problems since then! YAY!! (looks for wood to knock on. Lots and lots of wood.)
Anyway, I have high and happy hopes for the future. And again, thanks to everyone here for the info.