March 7, 2012
(NASDAQ: SPEX) – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies – today announced that one of its drug candidates, SPX-106T, arrested development and reduced atherosclerotic plaque area in the aortic arch, thoracic aorta and sinus of Valsalva in mice genetically predisposed to cardiovascular disease. Atherosclerosis can lead to myocardial infarction (MI) and stroke. Each year, about 770,000 people in
the United States
experience their first MI, and about one-third of these events are fatal.(1-3)
Two groups of apolipoprotein E-deficient mice (control and SPX-106T) were each fed a Western diet (high in fat and carbohydrates) for eight weeks. In the SPX-106T group, the sucrose portion of the dietary carbohydrates was replaced with D-tagatose and SPX-106 was added at 0.1%. Plaque area was quantified at three locations: the sinus of Valsalva on top of the heart, aortic arch, and thoracic aorta (Figure 1a). SPX-106T reduced atherosclerotic plaque areas almost 5-fold in all locations (p<0.05 in thoracic aorta, p≤0.01 in aortic arch and sinus of Valsalva). Photomicrographs of the sinus of Valsalva illustrate the reduction of atherosclerosis with SPX-106T (Figure 1b).
These results expand on previous work done by Spherix, which was presented at the American Association of Pharmaceutical Scientists (AAPS) 2011 national meeting in October, showing that SPX-106T significantly reduced serum cholesterol, the amount of subcutaneous, retroperitoneal, and epididymal body fat, and prevented body weight gain. These data also support Spherix's other findings that SPX-106T reduced atherosclerotic lesion areas in the aortic arches of LDL receptor-deficient mice fed fructose and glucose.
"As we continue the development program for SPX-106T, we are gaining valuable insight into the therapeutic potential for SPX-106T. We are looking forward to bringing SPX-106T into human clinical trials in 2012," noted Dr.
, CEO of Spherix.
LDL-cholesterol is a known risk factor for the development of atherosclerosis in humans.(4) Spherix has previously shown that LDL-cholesterol is reduced in LDL receptor-deficient mice treated with SPX-106T.