LCT Gets Russian Approval for Encapsulation Technology
LCT is in phase-I with their cure for type-1 diabetes, which is pig beta cells encapsulated so that the body's autoimmune attack can not get them.
LCT has received Russian government approval to market their encapsulation technology. This approval does not cover the porcine beta cells inside LCT's encapsulation tubes, but it does cover the tubes themselves. A future approval will be done for the porcine beta cells themselves. This is continued strong progress towards LCT's stated goal of general availability of their treatment in Russia by 2011.
To put it bluntly, this puts LCT one approval away from being able to sell their treatment in Russia. Now, at the moment, their treatment is not something that I would consider a cure. However, I do believe that they will continue to improve their treatment, and I think it is possible that in 5, 10, or 20 years it will grow into something that I would consider a cure.
Note: whenever I blog about LCT, I get asked "how much will it cost?". And the answer is: I don't know. LCT has not announced it, and it may not be decided as yet. The whole idea of discussing the price of a treatment which you can not yet buy, for me, is putting the cart before the horse. There are many other questions about this treatment that I think are more important, especially: what percentage of patients will be cured? And, how long will the cure last? Plus there is the issue of safety of something which has not gone through either US FDA or EU EMEA approval.
These guys published a press release recently, and so have been in the news. The press release was issued because they filed to get patient on their technology. The press release claims an 80% success rate but does not describe the treatment in any way. They do say that whatever it is, it will be available commercially in Germany in 2010, and other places after that.
Personally, I'll be ignoring this press release, because I can not find a single study in the scientific literature, which reports on their treatment, or it's success rate. I can't even find a reference to VUCCC prior to this press release.
press release: http://www.forbes.com/feeds/businesswire/2010/03/03/businesswire136160731.html
I'd like to thank Ellen for emailing VUCCC and posting their reply, which you can read here: http://islet.org/forum/messages/53711.htm
They make a number of claims which I find hard to believe. For example: they started phase-I human trials in 1990. They have completed phase-III trials (in 1996), and have since done two phase-IV trials (IV generally means more/new testing on already approved treatments) since then. They claim to have cured outright ("disease free") over 10,000 people (none of whom have ever posted to a public forum, of course....) They claim to have three papers written (one in 1996, another in 2002, and the third 2006) just waiting for the patient so they could be submitted to "Nature or a Journal of similar stature". So the authors of that first paper just sat on it for 14 years?
This is their description of their technology, starting with the fact that in type-1 diabetes, the body's own immune cells attack the body's own beta cells:
These haywire immune cells are produced by hibernating virus particles found in all Diabetics' islet cells. ... The goal of our treatment is to stimulate the islet cells to express these hibernating virus particles and enable the body to eliminate the cells carrying the hibernating particles once and for all which rids the body of these "bad" immune cells and replaces them with low physiological levels of inactive memory cells that can no longer attack the islet cells - thus stopping beta-cell damage and restoring proper immune function.That first sentence about hibernating virus particles is nothing I've ever heard before, so I"m not tempted to put much faith in the rest. (Plus it sounds like quack treatments I have heard of in the past.) And without published results, faith and wishful thinking is really all there is. But if anyone flies to Germany this year and gets cured, please do tell! :-)
INGAP (now called exsulin) is a treatment that is undergoing phase-II human trials, and is hoped to trigger the body to regrow lost beta cells.
First, a couple of researchers have found a way to make rINGAP (recombinant INGAP). The surprise was that rINGAP was approximately 100x as powerful as INGAP in test tube testing. If borne out in live animal (and later human) testing, this would be even better news. Exsulin has long complex history, so if you want more details, please ready my previous blog entries on it:
Second, Exulin has started another round of phase-II clinical studies. This is the study I had previously discussed here:
The update is two fold: first, they started enrolling patients in Nov 2009, and second, they hope to complete the study by August 2010.
Clinical trial record: http://www.clinicaltrials.gov/ct2/show/NCT00995540
Change in Blogging Policy
My policy is to blog on research "in human trials now, or has been in the past, or is expected to be within the next two years" which is aimed at curing type-1 diabetes. So in the past, I have included any research where the researcher claimed they would start a human trial within the next two years. Unfortunately, many researchers claimed this, but never started a clinical trial, even after many years. So I'm changing my policy, and will now only blog on research that has started the paperwork required to start a clinical trial (even if they have not yet quite started the trial itself). So if they have started the paperwork for a phase-I trial, or submitted the US FDA's IND paperwork, or anything similar to that. I also plan to drop coverage of any treatment which was in human trials, but has not been in human trials for a three year period of time. I expect these policy changes to give me more time to focus on more promising research.
Reminder About Terminology
Remember that many words are used differently by professionals, than by the rest of us. For example, if you ask people what it means to be a "honeymoon diabetic" most would say "Someone who was just recently diagnosed". But if you asked a researcher that same question they would say "Someone who is still making their own insulin (as shown by a C-peptide test, for example)", and the two are not the same thing.
Also, "vaccine". If you ask a bunch of random people what a "vaccine" is they would say "something which you give to healthy people to prevent them from getting a disease". But a health professional uses a different definition that sometimes includes treatments given to people who are already sick.
In general, I use the definitions used by parents and patients. The "general population" definitions, and not the health care professional's definitions.
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF news, views, policies or opinions.