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Spherix Incorporated
Biotech Specialty Pharma
6430 Rockledge Drive #503
Bethesda, MD 20817 USA
phone:301.897.2540
fax:301.897.2567
Symbol SPEX
Exchange Nasdaq
Founded 1967
Employees 10
www.spherix.com
Research Sector Biotech Specialty Pharma
Summary Description
Innovative biopharmaceutical products and consulting services
Management
Claire L. Kruger, CEO, COO; Robert A. Lodder, President; Robert L. Clayton, CFO, Treasurer; Katherine M. Brailer, Corporate Secretary and Director of Administrative Services
Ownership
Financials Mkt Cap :7
* numbers in thousands
 

Keywords
SPEX, Type 2 diabetes, triglycerides, clinical, biotechnology, pharmaceutical companies

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Updated: Feb. 01, 2012

Description
Spherix develops innovative biopharmaceutical products and provides technical and regulatory consulting services through subsidiaries Biospherics and Spherix Consulting. Biospherics has completed a global Phase III clinical trial investigating the usage of D-Tagatose as an oral anti-dyslipidemic agent for type 2 diabetes. D-Tagatose, originally developed as a reduced-calorie sugar substitute, is poorly absorbed in the small intestine, thus preventing stimulation of insulin secretion and thereby lowering blood glucose levels. Spherix owns patents for the usage of D-Tagatose as an oral treatment for glycemic control, and has filed patents for its usage in dyslipidemia and atherosclerosis. Spherix’s new lead product candidate is SPX-106T, a therapeutic combination licensed from the University of Kentucky College of Pharmacy for reducing triglycerides, cholesterol, and atherosclerosis. Subsidiary Spherix Consulting provides scientific and strategic support for suppliers, manufacturers, distributors, and retailers of various foods, consumer products, and pharmaceuticals, particularly in the areas of identifying health risks, environmental risks, and compliance with regulations. The mission of this later-stage biotechnology company is to create and grow shareholder value through successful worldwide commercialization of SPX-106T and D-Tagatose, as well as through the promotion of its consulting practice as a premier product regulatory approval and scientific advisory board.
Products / Services
D-tagatose is a novel, small molecule that has shown human proof of concept as a glycemic control and anti-hypertriglyceridemia agent in a Phase 2 and an initial Phase 3 clinical trial in Type II Diabetes, as reported in 4Q10. The initial Phase 3 clinical study in Type 2 Diabetes showed a statistically-significant 0.4% reduction of HbA1c compared to placebo after 10 months of therapy in the ITT population. The Phase 2 trial, using lower doses of tagatose, showed a statistically-significant 21% reduction in triglycerides from minimally elevated triglyceride in diabetic patients, a trend in reduction of LDL cholesterol (non-significant due to small sample size), and a linear dose response in reduction of HbA1c. D-tagatose is being used by Spherix as a platform for other drug products to treat atherosclerosis and the metabolic syndrome.
Technology / Differentiation
SPX-106, is one of five small, non-carbohydrate molecules in-licensed by Spherix last year. D-tagatose is a novel, small molecule that has shown human proof of concept as a glycemic control agent in an initial Phase 3 clinical trial in Type 2 diabetes and as anti-dyslipidemic agent in a Phase 2 study in Type 2 diabetics. Tagatose is an epimer of fructose and has a unique mechanism of action in glucose and lipid homeostasis. D-tagatose is believed to depress elevations of blood sugar levels in diabetic patients by increasing glycogen synthesis while decreasing glycogen utilization, resulting in an improvement of blood sugar control and modulation of HbA1c. Tagatose?s mechanism of action is believed to target adipocyte and hepatocyte effect on lipid homeostasis.



A development program in hypertriglyceridemia was initiated in 4Q2010, with a phase 1 study which will begin 4Q2011 or 1Q2012. D-tagatose is being used by Spherix as a platform for other drug products to treat atherosclerosis and the metabolic syndrome.

Tagatose has been approved by the FDA as a GRAS agent for food use and approved as a ?novel food ingredient? in the European Union (EU) without any restriction on usage. Tagatose was previously used as a food ingredient in the US and Europe, but is no longer being marketed as a food ingredient to pursue development as a drug agent.

In early 2011, Spherix initiated the preclinical development of SPX-106 and D-tagatose as a treatment for hypertriglyceridemia. In the completed study, treatment of animals using combination therapy with twice- daily oral dosing significantly reduced triglycerides by 43 mg/dl compared with control animals with a mean triglyceride level of 118 mg/dl (p=0.01). The same therapy significantly reduced total cholesterol by 73 mg/dl from a mean level of 378 mg/dl compared with control animals (p=0.01). SPX-106 is in preclinical development in combination with other agents, including D-tagatose, for the prevention and treatment of atherosclerosis, hypertriglyceridemia and related dyslipidemias.

The SPX-106/tagatose combination is the most effective of the treatments for lowering triglycerides.
? The SPX-106 dose is responsible for lowering most of the triglycerides in the blood, followed by tagatose.
? D-tagatose lowers triglycerides by -3.1 mg/dl per g/kg/dose of the sugar, while the SPX-106 lowers triglycerides by -372 mg/dl per g/kg/dose of the drug. Both glucose and fructose raise triglycerides.

The SPX-106/tagatose combination is the most effective of the treatments for lowering cholesterol. ? The SPX-106 concentration is responsible for lowering most of the cholesterol in the mice blood, followed by tagatose.
D-tagatose lowers cholesterol by -3.9 mg/dl per g/kg/dose of the sugar, while the SPX-106 lowers cholesterol by -629 mg/dl per g/kg/dose of the drug. Both glucose and fructose raise cholesterol.

In the recently completed study in 3Q 2011, treatment of animals using a range of low doses of SPX-106T twice- daily significantly reduced VLDL by 35% (from 127 mg/dl to 82 mg/dl) and LDL by 18% (from 141 to 116 mg/dl) (p=0.05). Importantly, the same therapy also reduced atherosclerotic lesion area in the aortic arch to less than one-half the value of the untreated group.

The SPX-106T (the combination of D-tagatose and SPX-106) reduced dyslipidemia in new studies of apolipoprotein E-deficient mice and Syrian Golden hamsters. This finding corroborates data obtained in LDL receptor-deficient mice (see Spherix press release of September 8, 2011). Additionally, a new study in rats demonstrates that D-tagatose inhibits fructose absorption in the gastrointestinal tract, providing further insight into the mechanism of action of SPX-106T.

The results obtained with SPX-106T in two strains of genetically engineered mice prone to dyslipidemia. SPX-106T significantly reduced VLDL and LDL cholesterol in LDL receptor-deficient mice fed normal chow. In apolipoprotein E-deficient mice fed a Western (high fat/high carbohydrate) diet, SPX-106T significantly reduced serum cholesterol by 30% (-307 mg/dl; p<0.05), prevented body weight gain (p<0.05), and significantly reduced the amount of subcutaneous, retroperitoneal, and epididymal fat (77, 90, 85% reductions, respectively, p<0.01) . SPX-106T did not affect the weight of other organs (heart, spleen, etc.). A recent range- finding dose study in hamsters fed the same Western diet and given SPX-106T provided evidence that the combination was effective in reducing serum triglycerides. The Company plans to start an initial human efficacy study in early 2012.
Market / Customers
Tagatose has the potential to compete in the multi-billion dollar dyslipidemic and diabetic markets.
Strategy
Spherix is seeking development and commercialization agreements and acquisitions to support continued development of tagatose in two different indications with two different dose/dose forms: (1) Type 2 Diabetes (using higher dose) and (2) Hypertriglyceridemia (using lower dose).

Spherix?s goal is to diversify its pipeline by licensing in new drug candidates. The Company has preclinical cardiovascular and metabolic drug candidates licensed from UKRF. The Company is seeking and examining opportunities in later clinical-stage compounds and orphan drugs.
Status
Spherix Incorporated was launched in 1967 as a scientific research company under the name Biospherics Research. The Company now leverages its scientific and technical expertise and experience through its two subsidiaries ? Biospherics Incorporated and Spherix Consulting, Inc. Biospherics is dedicated to developing and licensing/marketing proprietary therapeutic products for treatment of diabetes, metabolic syndrome and atherosclerosis. Biospherics is actively seeking a pharmaceutical partner to continue the development of its Phase 3 compound for the treatment of diabetes, D-tagatose, while exploring new drugs and combinations for treatment of high triglycerides, a risk factor for atherosclerosis, myocardial infarction, and stroke. Spherix?s Consulting subsidiary provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products and industrial chemicals and pesticides.

In June 2010, the Company announced that it would actively seek a pharma partner to continue the diabetes development and that it would also explore D-tagatose as a potential treatment for high triglycerides, a risk factor for atherosclerosis, myocardial infarction, and stroke. The Company has begun such exploration and is also evaluating other drug compounds it has licensed from the University of Kentucky. Recently, the Company has focused its studies on treating high triglycerides with a combination of D-tagatose and one of the licensed drug candidates, which combination is referred to as SPX-106T. Animal studies of SPX-106T are ongoing and an initial human efficacy study could begin in early to mid 2012.

Spherix holds the patents for use of D-tagatose as a treatment for Type 2 diabetes and the license for the pending US and foreign patent filings for SPX-106T in new formulations as a treatment for high blood triglycerides and related dyslipidemias. The Company has also filed for patent protection on a D-tagatose and metformin combination. The use patents for D-tagatose as a treatment for Type 2 diabetes expire in 2012, not including extensions. The use patent for the new SPX-106 and D-tagatose combination in the United States will last until twenty years after the date of the original PCT filing, as will patent protection on a D-tagatose and metformin combination. If D-tagatose is approved for use as a drug by the FDA as a treatment for Type 2 diabetes, the Company believes it will be eligible for a five-year New Chemical Entity (?NCE?) exclusivity period following FDA approval. Similar legislation in Europe could provide seven or more years of market exclusivity in the European Union, if approved by the European Medicines Agency (EMA). If SPX-106 is approved for use as a drug by the FDA as a treatment for high triglycerides and related dyslipidemias, we believe we will be eligible for a similar five-year New Chemical Entity (?NCE?) exclusivity period following FDA approval, and seven or more years of market exclusivity in the European Union, if approved by the European Medicines Agency (EMA). The Company is also exploring the possibility of obtaining by license or acquisition other clinical stage compounds/orphan drugs for continued development and commercialization.

Spherix is currently conducting preclinical and clinical development of tagatose as a treatment for hypertriglyceridemia, with a Phase 1 study starting in 2011. Spherix is seeking a licensing partner for tagatose to continue development in type 2 diabetes.

Spherix is seeking development and commercialization agreements and acquisitions to support continued development of tagatose in two different indications with two different dose/dose forms: (1) Type 2 Diabetes (using higher dose) and (2) Hypertriglyceridemia (using lower dose).

Spherix?s goal is to diversify its pipeline by licensing in new drug candidates. The Company has preclinical cardiovascular and metabolic drug candidates licensed from UKRF. The Company is seeking and examining opportunities in later clinical-stage compounds and orphan drugs.

Research and development is the focus of the Biospherics subsidiary, which operates using its own personnel, consultants and outside service providers, with the goals of developing D-tagatose and SPX-106T for future commercialization.

The clinical trials in the use of D-tagatose for the treatment of Type 2 diabetes were the primary focus of the Biospherics segment during 2010. Beginning in the fourth quarter of 2010, the Company began shifting the focus of its R&D efforts to the use of SPX-106T in lowering triglyceride and cholesterol levels. The shift from late stage trials to a pre-clinical trial resulted in a decrease in R&D costs between years; the Company anticipates that R&D cost will begin to increase again with the progression of triglyceride and cholesterol studies. An application for an Investigational New Drug (?IND?) for the D-tagatose and SPX-106 combination drug is being prepared for submission to the US FDA, and a human proof-of-concept trial may begin later in 2012. Combination therapy is an important tool in many complex disease settings, including cancer, infectious diseases, cardiovascular disease, diabetes and the metabolic syndrome. Scientific progress has increased understanding of the pathophysiological processes that underlie these and other multifactorial diseases. This increased knowledge has advanced new therapeutic approaches using combinations of drugs targeted at multiple therapeutic targets to improve treatment response and/or minimize development of drug resistance. In settings like metabolic syndrome, in which combination therapy may offer significant therapeutic advantages, there is increasing interest in the development of combinations of investigational drugs not previously developed for any purpose.

The Company estimates that it will likely take 3 or more years to complete the studies/trials necessary to attract a pharma partner to complete the development and an additional 2-4 years to complete all necessary studies for an NDA filing for D-tagatose or SPX-106T.

The Company is seeking to in-license or acquire additional drugs to diversify its pipeline. Clinical-stage compounds (phase 1 or phase 2) are of particular interest, as are orphan drugs, which can be eligible for accelerated approval processes.