EIGHTY-FIVE PERCENT of diabetes patients require medication to control blood sugar levels. This consists of oral or injected administration of insulin, or other hypoglycemic medication, and does not account for medical treatment of associated complications, which can only be managed.* A key point is that diabetes is a progressive disease, and the best that can be hoped for is that treatment slows its progress. Current research focuses on stem cell and islet cell transplants. While these approaches may appear promising, they will require extensive time, money, and ethical debate before gaining widespread use.
The Institute's approach to ending the crisis is through the use of extremely low levels of specific antibodies that are directed against targets involved in the disease process. By interrupting the steps in the progression of disease, Institute researchers regard diabetes to be controllable, meaning that the progression of the disease can be stopped. Indeed, early anecdotal human experience indicates that diabetes may actually be reversible, meaning that the patient may be able to stop medical treatment.
The Institute's low-level antibody therapy (LLAT) has been patented, both as a general process and for diabetes and diabetic neuropathy in particular. Evidence already gained from animals and humans is compelling.
- The LLAT approach appears to be effective with Types 1 and 2 diabetes. Especially with Type 2, there is a marked improvement in quality of life as demonstrated by increased vitality, decreased weight, and improved vision.
- All human patients suffering from diabetic neuropathy—spanning a spectrum from extreme pain to no pain and no feeling—have reported a return toward normal sensation in their extremities.
- For most patients, the LLAT approach began working within 30 days.
- In dogs, cats, and humans, all patients have derived some level of benefit from treatment.
- There have been no observed adverse side-effects in any of the three species.
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As LLAT uses naturally-occurring, known molecules, a significant amount of research and monetary expense can be avoided. Several years and millions of dollars will be saved as there is no need to develop new molecules which must then undergo rigorous testing for toxicity and efficacy. With a relatively modest expenditure, the diabetes LLAT is now ready for additional animal testing en route to human trials.
Investigators at the University of California, Davis, recognized experts in the field, have proposed a series of experiments in rats and primates.
Funding will also enable novel laboratory research focusing on examining the roll of those proteins that have been shown to be associated with the status of disease progression.
Once the proof-of-concept has been established, either prior to human trials or immediately thereafter, this product will be licensed to the appropriate corporate partner with the goal of delivering it to the marketplace.
The end result of successful Institute research is that millions of people suffering from diabetes and its many complications will have a safe, effective, breakthrough treatment.
THIS VISION stems from positive anecdotal clinical results and laboratory data. Such results are based on the current hypothesis of the agent's mechanism-of-action (MOA). Rigorous MOA studies are planned to define the specific actions of the therapeutic agent in the diabetes disease process. The following step is to enter into FDA-approved clinical trials.
The Institute's novel approach to treating diabetes is expected to serve as a prototype to address other diseases having an autoimmune component. Indeed, current Institute research is laying a foundation to support an entirely new therapeutic platform focused on controlling or reversing a spectrum of disorders that currently defy most medical intervention.
* The National Institutes of Health
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