Media Contact: Ann Blackford
LEXINGTON, Ky. (Dec. 16, 2009) −A unique sweetener
that actually controls blood sugar just might be the dream of diabetics
everywhere. Now, thanks to the efforts of a University of Kentucky College of Pharmacy
professor and his drug company, Spherix, this dream is one step closer
to reality. An interim analysis of the global phase 3 clinical trial
results for D-tagatose, a novel compound used in the treatment and
management of Type 2 diabetes, showed a reduction in HbA1c and key
blood lipids as well as Body Mass Index (BMI).
D-tagatose, which occurs naturally in small amounts in dairy
products, is a highly soluble white crystal or powder, can be produced
with a physical bulk similar to ordinary table sugar, and is 92 percent
as sweet. In a U.S. phase 2 study designed to establish the minimum dose
capable of causing a beneficial effect on HbA1c, D-tagatose was
administered orally three times a day with meals at three different
doses. As in the phase 3 trial, results from phase 2 clinical trials
have also shown a reduction in hemoglobin A1c (HbA1c) after six months
and a reduction in serum triglycerides after one month of the trial.
Robert Lodder, professor in the Department of Pharmaceutical Sciences
and president of Spherix (NASDAQ CM SPEX), a scientific research
company, said that when D-tagatose enters the market as a treatment for
diabetes, it will be as a prescription drug. Unlike other drugs used to
treat diabetes, the product has been deemed Generally Recognized As Safe
(GRAS) by the Food and Drug Administration (FDA), a designation that a
chemical or substance added to a food is considered safe by experts and
so is exempted by the usual Federal Food, Drug and Cosmetic Act (FFDCA)
food additive tolerance requirements.
“The interim results of our ongoing clinical trials are encouraging
and support the hypothesis that D-tagatose may be an important treatment
option for patients with Type 2 diabetes,” Lodder said. “These data,
combined with the fact that D-tagatose is an epimer of fructose with no
known adverse interactions with current Type 2 diabetes treatments,
continues to lead us to believe that there will likely be a place for
D-tagatose in the treatment regimen as either a stand-alone or an
adjunct therapy. In addition, the beneficial effect on serum
lipoproteins and BMI may lead to a role for D-tagatose in the treatment
of atherosclerosis and the metabolic syndrome.”
Dr. Dennis G. Karounos, associate professor of medicine in UK's Department of Internal Medicine, Endocrinology Division, is a principal investigator at the UK phase 3 site in the Spherix global clinical trial.
“We are excited about being part of this trial to evaluate tagatose
as a new therapy for type 2 diabetes that is not quite controlled by
diet or exercise alone," Karounos said. "Tagatose has the potential to
be a therapy that patients can incorporate into their meal plans to
improve blood sugar control yet have minimal side effects.”
The Investigational Drug Service at UK
also plays an important role in the Spherix trial by providing a means
to test new manufacturing batches in human subjects. In fact, the GRAS
designation of D-tagatose for use in foods provides unique
opportunities for drug formulation. Currently, Granny's Goodies, a bake
shop in Georgetown, Ky, is formulating D-tagatose in candy, cookies and
cakes solely for Spherix and UK for research purposes and with good
results. These dosage forms can be labeled as foods and used as
consumer test samples to optimize D-tagatose delivery.
“The University of Kentucky provides unparalleled opportunities for
entrepreneurial scientists interested in translational (“bench to
bedside”) research,” Lodder said.
Five pipeline drugs from Lodder’s laboratory at UK are being patented
and licensed to Spherix, and several of Lodder’s publications have UK
and Spherix coauthors.
“The College of Pharmacy is poised for incredible progress,” Lodder
noted. “The huge new state of the art building, the opportunities for
collaboration, the atmosphere that encourages translational research and
commercialization all make Pharmacy and UK the place to be in the
Type 2 diabetes mellitus is the most common form of diabetes. In Type
2 diabetes, the body does not produce enough insulin or the cells
ignore the insulin (insulin resistance). While Type 2 is often initially
managed by increasing exercise in conjunction with dietary
modification, medications are usually needed as the disease progresses.
There are an estimated 23.6 million people in the U.S. with diabetes and
17.9 million cases have been diagnosed. Of the diagnosed diabetes
cases, 90 percent are Type 2.