Allies Voice: Oral-lyn needle-free insulin in Phase 3
A little over a year ago I blogged about a company called Generex. Their flagship product is called Oral-lyn®, a spray form of insulin that enters the body through the inner lining of the cheek. Imagine the future of coverage and correction without needles! Standby 'cause the future of needle-free insulin is closer than you think. Generex announced in April that supplies for a six-month U.S. trial are ready to be shipped to clinical sites.
Oral-lyn is administered through a hand-held device that looks a lot like an inhaler. The insulin begins working within 15 minutes and the onset profile last approximately 2 hours. This is ideal for preventing post-parandial lows and erratic hypos. Oral-lyn is more efficiently absorbed in comparison to injections. The body effectively absorbs between 20% and 40% of injected insulin. Insulin from the Oral-lyn Rapid Mist delivery system absorbs 60% to 80% into the blood stream. Furthermore, effective absorption with the Oral-lyn RapidMist device may help reduce daily dose requirements - enhancing patient compliance and reducing overall complications. Less waste - more control sounds like a win-win situation.
Studies have shown that controlling blood glucose with less insulin presents favorable outcomes in preventing long-term complications. Oral-lyn could become the first choice in treatment for newly diagnosed Type 1 and Type 2. Small doses, superb safety and a discreet device...I think we're on to someething big, folks! I'll even take it a step further and speculate that Oral-lyn could possibly be an answer to arresting pre-diabetes from becoming Type 2. Staving-off diabetes with something as unimpressive as a canister of mouth spray - fanciful thought with pragmatic imminence.
The proprietary delivery system adds an extra feature of protection from hypoglycemia. The absorption rate is impressive with a majority reaching the blood stream through the buccal mucosi. However insulin not absorbed in the cheek will pass through to the stomach (not the lung) where the stomach acids will denature the insulin. Denatured insulin cannot cause hypoglycemia.
The generic insulin used in Oral-lyn is U-500. Many of us are most familiar with U-100 insulin. This means that the fine mist of Oral-lyn is 5x stronger than traditional insulin. The Rapid Mist device delivers 1 unit of insulin per puff. As mentioned before injected insulin, unit for unit, is only absorbed 20% to 40% per dose. A majority of the Oral-lyn fine mist insulin is absorbed. This validates Oral-lyn as the more efficient insulin choice for precise dosing. In case you were wondering about price - the estimated cost for Oral-lyn is $30 to $40 per device.
Generex performed studies showing that administering Oral-lyn in split-dosing (half before a meal and half after) was more effective in controlling average blood glucose readings (HbA1c) than analogue protocols. If your barometer is the "numbers game" (and for many of us it is nothing BUT numbers) Oral-lyn may be the breath of fresh insulin you've been waiting for.
To get a close up of the Oral-lyn RapidMist in action - checkout this FOX News clip!
For more information about this revolutionary product - visit the Oral-lun product page on the Generex site, Check back for more details on Phase 3 and availabililty of Oral-lyn.
thass very Good News* Especially w/ most Diabetics taking 3 to 4 Shots of Insulin Daily* I like the fact it's released in a Fine Mist + absorbed by the Body much better which is one reason I like the Preci-Jet Needleless Injector so much*
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............now if we can only do something in preventing all those nasty Complications from Diabetes taking place, which I have posted on my site bettercell.blogspot.com
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I have concern about U-500 insulin. Although they note that 60% to 80% is absorbed, bur that is still a fairly wide range.
Although it appears to be more precise than Exubera and other alternative delivery mechanisms, my feeling is that the movement towards ever more concentrated insulin could be dangerous for people with impaired counterregulatory systems. This trend is being driven by the drug industry's lust after the enormous type 2 market, but could be quite dangerous for insulin-sensitive type 1 patients.
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Uhhhh..... I must admit to a bit of confusion and to a lot of skepticism. If this new wunderdrug is absorbed at a 60-80% rate but is administered at a 5x strength dose - isn't it about the same thing as a 1x strength dose that's absorbed at a 20% rate? The same amount gets in. I hate to sound like such a curmudgeon, but it sounds like "old" math to me in new packaging. And before I start inhaling anything and subjecting very sensitive cells to a direct and higher strength drug, I'd have to see hard core major clinical studies with lots and lots and lots of people that have statistical significance and sufficient power as well as proven to do me no harm - unlike the drug I took that got me into this mess in the first place...and unlike the so called "studies" that approved "human" insulin....
Kelly
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Hi Kelly,
Please email to discuss ... You can find my email address at www.HYPO-thesis.cOM
…Warm thanks & Adrenalin Love
Nick Gracey, BSc(Hons) Medical Biochemistry, Birmingham University, UK, WATerian (C) MON.11.AUG.2008 @ 10:10hrs c/o www.LoveDiabetes.cOM & www.LIFE2345.cOM
.
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Although there may be slight medical benefits to this delivery system, I am generally dismayed at all the scarce research resources which have been invested in one contraption after another to deliver insulin by some route other than injection, when so many truly curative potential therapies -- INGAP, Faustman's work, Living Cell Technolgies' research, etc. -- are now languishing for want of money.
The problem here is that most of the medical world's understanding of the problems of diabetes is shaped by people who have no idea what real diabetics think, what they want, or how they live. So they take one cursory look at the disease, decide that the 'terrible pain' of insulin injections must be the major issue, and then go about addressing that. But if they had bothered to ask any type 1 diabetics, they would have quickly discovered that within a week of diagnosis, no one minds insulin injections a bit.
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FYI, the VP of Generex (who is developing Oral-lyn) is Dr. Bernstein who just happens to be the ex-president of the American Diabetes Association. I believe he DOES have an idea of what real diabetics think.
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The ADA is an organization that represents the interests of IRD (Type 2 Diabetes) and not T1DM FYI.
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Steven—
I don’t know Dr. Bernstein, so to question his integrity, his knowledge or his credibility is speculative. But for you to imply that his affiliation with the ADA in a leadership role somehow automatically equates with his understanding how and what diabetics want is ludicrous. The ADA—once a mission-driven advocacy group—has morphed over the last 2 or 3 decades into a profit-driven quasi-corporation hiding behind a veil of charitable entitlement. The ADA (leadership) determined that the big bucks were to be gleaned from the burgeoning Type 2 population, and significant revenues could be garnered by accepting the role of industry propagandist. Like most corporations today, ADA chose to “follow the money.” Your promotion of Dr. Bernstein via his ADA-connection is an effort in futility or flawed-logic when presented to a group of long-time diabetics who have found self-reliance trumps ADA propaganda.
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Hi,
As an investor and brother to a Type 1 that has suffered much from Type 1 complications, I have follow Generex closely and can share a little info regarding their Medical Affairs VP:
Dr Gerald Bernstein an attending physician at Beth Israel Medical Center, and for years was the Director of the Beth Israel Health Care Systems Diabetes Management Program. He is physician emeritus at Lenox Hill Hospital and Montefiore Medical Center, all in New York. Dr. Bernstein was president of the American Diabetes Association in 1998-99 and was for many years a member of the ADA's Board of Directors and its Executive Committee. He presently serves on several ADA committees and on the Board of Directors of the American Diabetes Association Research Foundation.
Dr Jaimie Davidson at Generex also has an impressive resume:
http://investor.generex.com/releasedetail.cfm?ReleaseID=250288
The Oral-lyn Phase III Principal Investigator is UT's Dr Philip Raskin. He also is a lead investigator of the Type 1 Diabetes TrialNet Prevention study:
http://www.utsouthwestern.edu/patientcare/dallas/clinicaltrials/medical/advertisement.html?formId=33659
At the Generex Annual meeting a couple of months back, Dr Davidson remarked that Oral-lyn may be introduced to the Type 1 TrialNet studies.
Generex's subsidiary (Antigen Express) is also working on a diagnostic kit for screening as well as a potential vaccine. Both efforts were presented at this year's ADA Scientific Sessions. This is about the kit:
http://www.newswise.com/articles/view/541495/">http://www.newswise.com/articles/view/541495/
I have also been a fan of Allie's and was very disappointed when AOL stopped publishing the Diabetes and Cancer Blogs. I'm glad I found her again. Thank's for all your efforts Allie, and in your own hard fought persuit of raising cash to help diabetics find a cure.
http://www.newswise.com/articles/view/541495/">http://www.newswise.com/articles/view/541495/
You are a gem!
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With non-diabetics driving the bus for both diabusinesses (profit before patients) and decision-making (prestige before patients) in regard to how and where research dollars are spent, one questions how progress can EVER be achieved. We now how more toys, more bells and whistles, more 'metrics' to define individual 'successes' . . . but results (complications, quality of life) are not improving. I have long wondered WHY some of these DIRECTORS of diabetes exploration fail to recognize that inclusion of living, breathing (T1) diabetics on their illustrious boards is worthy of consideration. As Sanktpauli notes, 'painful' injections are NOT high on the list of problems with which diabetics must contend. Incorporating a few long-time diabetics as 'advisors' to these isolated decision-makers might offer TRUE PROGRESS. Alas, I am preaching to the choir!
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Alas, most of you already know this . . . but research in this manner is like mining for fool’s gold. We all know insulin is an anabolic hormone which, among other counterproductive actions, includes stimulation of fat-producing cells at the site where excess occurs. Anyone who has been on a pump for an extended period of time or taken shots at various sites for an extended number of years are familiar with fat overgrowth.
If we allow the industry to continue this type of research and exploitation, we (as a patient-consumer group) will be identifiable by the size of our cheeks. We’ve long been able to maintain at least a veneer of normalcy . . . oral-misting will strip away this illusion. Perhaps creative propaganda will allow us to embrace our future chipmunk-like appearance.
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I have been following this company for more than 2 years now while they have been doing their R&D. I do believe that this will take the place of inhaled insulin for covering post prandial spikes in blood sugar. Oral-lyn will be especially welcomed in countries like China and India where there is an explosion in Type 2 diabetes. I think it will be demonstrated in clinical studies that it is easy to use, effective in controlling post meal blood glucose, and accepted by the people who need to use it. The questions remaining however are will it be affordable and are there any side effects from long term use?
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Florian,
Another question may be: "Is this an enabling tool that, because of ease-of-use, allows T2's to deal with post-prandial bG elevation without making any significant, beneficial life-style changes?" And, as you state, will continued use, or overuse, have long-term side effects?
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How about working on a cure? Stem cells or anything that would eliminate this issue for millions of us. Let's really get down to the business at hand. Oh yea, it is the business at hand for producing products we still would have to pay for and deal with. Let's work on a cure and cut out the marketing of diabetes we all need a solution to this situation not a one day gas tax relief.
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How can it not get into the lungs if it's inhaled through the mouth?
Also, why find a cure for IDDM when there's money to be made on keeping the disease alive? New types of insulin, new meters, insulin pens, new pumps...oh joy!
Yes, I've become quite pessimistic over time. Yea, ADA is like the CDA here...cater more to people with type 2. Why not, it's an epidemic now...lots of money to made. I'll never forget when I had someone from CDA go into my son's classroom (shortly after he was diagnosed) and talk about diabetes. The next day, I went into the school to see that she had left a poster that was put up in the hall that said "diabetes can be prevented". Umm, as far as I knew, my son's IDDM could not have been prevented. Then there's JDRF...
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The key to capitalism is to rent forever rather than sell once. That is why all real estate in London is sold as a 99-year lease rather than as an outright sale, and also why Bell Telephone used to rent people their phones at a monthly rate rather than selling them. When this rule is applied to medicine, it requires Big Pharma never to find cures but only to find new, ingenious, and ever more expensive treatments which have to be bought and re-bought forever. Every time I see another ad on television for glucometers and blood glucose testing strips, I see the chances for a cure fading into the background, since capitalism has discovered what a perpetual cash cow we can be.
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i just wish i new the information that
the pharms, (elli lilli) (nova nordisk) etc. have, about possible cures,
clinical trial results, etc. that we will never know.
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does anyone know where i can find, clinical test results from Dr. Vinik
ingap peptide...before elli lillie got
hold of it,
i'm new here but have been insulin
dependant for about 16 years, i have
a 14 year old son that was diagnosed
about 3 years ago....just doing a
little research and get disgusted
when the big (treatment co's) get
hold of a possible cure?
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Please forgive one introductory snarky comment: If you could (through FOIA) obtain a copy of the NDA for Lilly’s human insulin—you would be appalled at what has been shoved at us. The application essentially showed that their product lowered blood glucose (much like natural insulin) . . . and it apparently didn’t kill anyone (right away). The technology was not available then that allowed Lilly to PROVE that their product was, indeed, human insulin—but the FDA did not have technology to PROVE that it wasn’t. So—awaiting required post-marketing studies (which never materialized) and evolving analytical/technological equipment, we have been guinea pigs in a long-running EXPERIMENT. That should make you feel good.
Now, to explore what “inventions” may have been produced (and shelved) . . . you can have hours—no, make that days—exploring the USPTO (at USPTO.gov). You select search words, and the adventure begins. One patent leads to another . . . referenced patents (that show a “new” patent is, indeed, patentable) will take you down many interesting roads. Patents are often broad in scope (inventors seek to garner as much intellectual property protection as possible), and proprietary information may not be all that you wish for . . . but I think you would experience a real eye-opening journey. Good luck. You will be interested to note, in background and discussion sections, some of the information divulged about new products that actually denigrate products already on the market. (For instance, Lilly’s patent application for human insulin STATED that bovine Ultralente was the GOLD STANDARD for basal control.) Obviously no one at the FDA was told . . . or if they were told, they chose to ignore the information.
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Alma--
Here's a good example. Go to USPTO.gov, access their 'search patents' and type in 6949070. You can read about a non-invasive blood glucose monitor that sounds intriguing. Why isn't it on the market yet? Well . . . we wouldn't want to impede the sales of the already-approved, very expensive (and problematic) INVASIVE bG monitors that the BigBoys of pharma are selling, now would we? And for those who cannot afford that equipment . . . why would we want to curtail the copious use of blood glucose monitoring strips that we use multiple times a day (sometimes with errors messages) in our current bG monitors that are ALLOWED to be sold to us despite a recognized plus or minus error factor of 10%. (10% too high, 10% too low gives an actual 20% margin error--and this is considered ACCEPTABLE?!) But hey, the monitors come in such pretty colors, deliver their (often inaccurate) results in mere seconds, and offer us great feelings of security and "job well done" each time we test! I could understand if errors were acceptable in the first generation of monitors--but hey, they've been on the market for awhile now . . . but I guess speed and fashion trump accuracy.
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I have been told by an endocrinologist who is a family member that oral insulin can cause lung damage. Be careful!
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That was the product that was discontinued last year, because no one wanted to use a tube that big, and it could only dose in 1 u or 3u single doses, and 3 1u were not equal to 1-3 unit go figure?
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Isn't part of the purpose of Allie's blog here to help generate monetary support for Denise Faustman's Clinical trials?
As a point of interest, do a site search for "Faustman" on the JDRF and ADA web sites. Interestingly enough (and assuming I read correctly), the most recent article on the JDRF site is a "Eureka!" type of article from 2001 about Faustman's research and it's merits. It's surprisingly free of arguments or de-merits! Sadly, this old article seems to be the last update regarding her work, and the site is now plastered from end to end with "Artificial Pancreas Nearing Pharmacy Shelves!" headlines.
It's a true conundrum; I'd hate to see all of these people lose their jobs, and pharmaceutical companies lose their profit margins, but if Faustman's research continues to show positive results, I'm most definitely on the band-wagon. - For myself, and for everyone out there scratching your heads wondering why resesarch like Faustmans gets 'blacklisted'. -Wiki it, Now! -Or even choose a reputable source of information, you'll be amazed!
Now, I will admit I know very little about Faustman's work from *Any* perspective, medical, bureaucratic or other, but from what I have read... I am in utter disbelief that this has not been funded to the hilt from the very
beginning.
My impression: The cure may be there staring you in the face, so Freaking do something!
If I'm not totally off base here (and please correct me if I am) can we rally to get some support flowing in the direction of Boston, where Dr. Faustman's research is happening?
- A personal "Thank you" to Lee Iacocca for his generous contribution(s) btw!
I haven't perused this blog site yet, just stumbled upon it, but Allie: can you post any extra information?
Best health to everyone!
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I need free or cheap insulin for my step son who is diabetic. He keeps asking us for cash for it and it's breaking us. Thank you. Sincerely,Julie Barnes
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Hi Julie - Your step son should checkout Diabetic Rock star at: http://www.diabeticrockstar.com.
My friend, Christopher Thomas, created the community that boasts a sympathetic and supportive group of people. PLUS – the foundation behind Diabetic Rock star, FightIT, may be able to offer him assistance:
Diabetic Rockstar is also the host of the non-profit campaign Fight IT!, a unique charitable venture helping uninsured, in-need and newly diagnosed diabetics. Blending the Community with the Charity, we can make a huge difference in the lives of many Rockstars who are fighting every day to make a difference in the world.
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How are you. For one human being to love another; that is perhaps the most difficult of all our tasks, the ultimate, the last test and proof, the work for which all other work is but preparation.
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Thanks for the help :o, Odele.
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cool post
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