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SPEX – Research / DD & Charts - Portfolio 2011 -- Presented By AugustaFriends

Spherix Inc.6430 Rockledge Drive
Westmoreland Building Suite 503
Bethesda, MD 20817
United States - Map
Phone: [phone]
Fax: [phone]
Website: http://www.spherix.com



Pending Phase Results - in January 2011
Estimated Enrollment: 550
Study Start Date: April 2007
Estimated Study Completion Date: December 2010Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

http://clinicaltrials.gov/ct2/show/NCT00955747?term=spherix&rank=1

Business Summary
Spherix Incorporated, SPEX together with its subsidiaries, operates as a scientific research company. It is developing D-tagatose that is in Phase 3 clinical trial for the treatment of type 2 diabetes. The company also 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 addition, it offers technical and regulatory consulting services to biotechnology and pharmaceutical companies. The company was founded in 1967 and is based in Bethesda, Maryland.

Profile: Spherix Incorporated was launched in 1967 as a scientific research company. The company now leverages its scientific and technical expertise and experience through its two subsidiaries—Biospherics Incorporated and Spherix Consulting, Inc. Biospherics is currently conducting a Phase 3 clinical trial investigating the use of D-Tagatose, a stereoisomer of fructose already approved as a sugar substitute, as a treatment for glycemic control in patients with Type 2 diabetes. Spherix Consulting 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.
As its primary goals, Spherix is seeking to successfully commercialize D-Tagatose in the U.S. and other markets, to advance its pre-clinical pipeline, and to promote its consulting practice as the premier product regulatory approval and scientific advisory service.

The Company’s mission is to create and grow shareholder value through innovations that benefit its clients and the human condition. Spherix offers innovations in biotechnology, and provides technical and regulatory consulting services to food, consumer product and pharmaceutical companies. Through its two subsidiaries, Biospherics and Spherix Health Sciences Consulting, Spherix strives to better the human condition.

• The Biospherics mission is to be an innovative company developing and commercializing proprietary health, drug, and medical products and processes.
• The Spherix Consulting mission is to provide the necessary strategic, regulatory, and scientific support to our clients for the purpose of securing their successful market position by assuring the safety, regulatory compliance/approval and benefit of their products.

Headquartered in Bethesda, Maryland, Spherix common stock trades on the NASDAQ under the symbol SPEX

Recent News :
Press Release Source: Spherix Incorporated On Thursday December 9, 2010, 10:00 am EST
BETHESDA, Md., Dec. 9, 2010 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq:SPEX - News), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its Phase 2 diabetes clinical trial, designed to determine the minimum dose of D-tagatose capable of reducing HbA1c, found that the minimum dose capable of affecting HbA1c (7.5 g three-times daily, or TID) was within the range of doses tested (2.5, 5.0, and 7.5 g TID), with the 2.5 and 5.0 g doses producing similar responses to one another, and the 7.5 g dose producing a greater response.
In addition, by the end of the six-month trial, the 7.5 g dose reduced serum triglycerides vs. the 2.5 g dose by -42 mg/dl from a mean of 180 mg/dl in the Evaluable Efficacy (EE) population. The reduction in serum triglycerides became statistically significant in the Intent-To-Treat (ITT) population at three months of treatment (-31 mg/dl, p=0.03) and the reduction essentially held steady at the six-month end-of-study visit (-29 mg/dl).

Press Release Source: Spherix Incorporated On Wednesday December 8, 2010, 12:58 pm EST
BETHESDA, Md., Dec. 8, 2010 /PRNewswire/ -- Spherix Incorporated (Nasdaq:SPEX - News), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the signing of a multi-unit research contract between its wholly-owned subsidiary, Biospherics Incorporated, and a leading global contract research organization (CRO) to investigate the role of D-tagatose in lowering triglycerides. Work will begin immediately and continue through at least 2011.
"We are optimistic about the potential of D-tagatose to lower triglyceride levels and therefore we are investing in an aggressive drug development program," said Dr. Claire Kruger, Chief Executive Officer of Spherix. "The market for triglyceride-lowering drugs is robust, and exceeds $3 billion annually in the United States. We believe that, should our studies be successful, there will be an important role for D-tagatose to play in the treatment regimen."

Press Release Source On November 24, 2010, Spherix Incorporated (the "Company") received written notification (the "Notice") from The NASDAQ Stock Market ("NASDAQ") advising the Company that the bid price of the Company's common stock (the "Common Stock") for the previous thirty (30) consecutive trading days had closed below the minimum $1.00 per share (the "Minimum Price Requirement") required for continued listing on the NASDAQ Capital Market pursuant to NASDAQ Rule 5550(a)(2) (the "Rule"). The Notice has no effect on the listing of the Common Stock at this time.

Pursuant to NASDAQ Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until May 23, 2011, to regain compliance with the Minimum Price Requirement. The Notice further provides that NASDAQ will provide written notification stating that the Company has achieved compliance with the Rule if at any time before May 23, 2011, the bid price of the Common Stock closes at $1.00 per share or more for a minimum of ten (10) consecutive business days, although, under certain circumstances, NASDAQ has the discretion to require compliance for a period in excess of ten (10) consecutive business days.

If the Company does not regain compliance with the Rule by May 23, 2011, and if the Company is not otherwise entitled to a further compliance period, NASDAQ will provide notice to the Company that the Common Stock will be delisted from the NASDAQ Capital Market. If the Company receives such a letter, the Company will have an opportunity to appeal the determination to a NASDAQ Hearings Panel.
The Company's stockholders have previously approved and authorized the Company's Board of Directors to effect a reverse stock split at any time prior to mid-May, 2011. The Company's Board of Directors will consider whether and when to implement such a split.

Press Release Source: Spherix Incorporated On Monday November 15, 2010, 11:24 am EST
Spherix Announces Third Quarter 2010 Financial Results

BETHESDA, Md., Nov. 15, 2010 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq:SPEX - News), an innovator in biotechnology for therapy in diabetes and the metabolic syndrome, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today reported results for the three months ended September 30, 2010.
Recent and Upcoming Highlights
• Pharmaceutical Development
o Announced exploration of D-tagatose as a treatment for high triglycerides, a risk factor for atherosclerosis, myocardial infraction, and stroke
o Acquired development and marketing rights for D-tagatose for triglycerides from the University of Kentucky Research Foundation
o Goal of the triglycerides program is to explore drug mechanism of action, investigate proof of concept and analyze the formulation, dose and dosing regimen appropriate for the triglyceride market segment
o Announced efficacy results of the Phase 3 trial for the treatment of Type 2 diabetes in October 2010 which showed a statistically significant drop in HbA1c levels in mild diabetics
o Anticipated completion of the Phase 2 Dose Range trial by the end of 2010
o Seeking a strategic relationship with a pharmaceutical company for the continued development of D-tagatose as a treatment for Type 2 diabetes and triglycerides
o Presented and participated at two pharma partnering meetings: BioPartnering Europe, October 11-13, 2010, London UK; and Windhover Therapy Area Conference, November 3-4, 2010, Boston, MA
o Awarded $469,479 under the Patient Protection and Affordable Care Act

• Health Sciences Consulting
o Recent and upcoming trade and professional shows:
? Presented at 9th Vahouny Fiber Symposium, June 9, 2010, Bethesda, MD
? Attended American Society of Pharmacognosy, Phytochemical Society of North America, July 10-14, 2010, St. Petersburg Beach, FL
? Attended 2010 IFT Annual Meeting & Food Expo, July 12-20, 2010, Chicago, IL
? November 1-3, 2010, Invited by the NIOH of South Africa to present a series of lectures dealing with Risk Assessment and Food Safety in Johannesburg, South Africa
? Presented "Food Ingredient Approvals: The Science and Regulatory Process for GRAS Determinations in the US and Novel Foods in Europe" at the Health Ingredients Japan 2010 Conference in Tokyo
? Presented "Stevia...The Science Behind the Sweetness" at the Supply Side West post-conference Stevia: Trends, Product Development and Regulatory Update Workshop in Las Vegas, October 23, 2010
? December 8, 2010: Invited to present "Probiotics: Advances in the Assessment of Safe Use" during Virgo Publishing's Probiotics Webinar

In addition to its lead program, Biospherics is applying its expertise in chiral carbohydrate chemistry to create a pipeline of proprietary candidates across a range of therapeutic indications



Diabetes is a condition in which the body either does not produce enough or does not properly respond to insulin. Insulin, a hormone produced in the pancreas, enables cells to process glucose and turn it into energy. When the body fails to process glucose, it accumulates in the blood, leading to a condition known as hyperglycemia, which, if left unaddressed, can lead to serious complications, including kidney damage, neurological damage, cardiovascular damage, and loss of vision. Diabetes treatments aim to maintain blood glucose at a level as close to normal as possible, in order to avoid these serious long-term complications.

There are two major types of diabetes: Type 1 diabetes (previously referred to as juvenile or insulin-dependent diabetes), an autoimmune disease that destroys the body’s ability to produce natural insulin, and Type 2 diabetes (formerly referred to as adult-onset or non-insulin dependent diabetes), a condition that results from the body developing insulin resistance.

According to the American Diabetes Association, approximately 90% of Americans diagnosed with diabetes have Type 2 diabetes, resulting in an estimated U.S. population approaching 24 million, or almost 8% of the total population. In addition, it is estimated that there are approximately 57 million people in the U.S. with a condition known as ‘pre-diabetes,’ which occurs when glucose levels are higher than normal but not yet high enough for a diagnosis of Type 2 diabetes.

Although Type 2 diabetes is initially managed by change in lifestyle, including increasing exercise, modifying diet and weight loss, medications are typically needed as the disease progresses. Despite the many treatments currently available, it is estimated that glucose levels in more than half of the U.S. population are not properly controlled. Market research suggests this lack of control most likely due to poor patient compliance and the lack of potency of marketed therapeutics. Risk of hypoglycemia, or too low blood sugar, from overuse of medicines combined with high rates of adverse events have also been blamed for poor patient compliance and reduced physician prescriptions.
Market research has indicated that physicians readily accept new diabetes treatments that demonstrate even a small benefit in efficacy if they are proven to be safer. Early clinical work on D-Tagatose indicates that the candidate may have several characteristics that, if approved, would be viewed favorably by the market, including:

• No evidence of hypoglycemia,
• Oral availability via a variety of formulations,
• Indications of appetite suppressant effects, and
• Demonstrated ability to lower blood glucose as measure by HbA1c.




To obtain a Brochure: http://spherix.com/pdf/d_tagatose_brochure.pdf


Biospherics’ lead clinical candidate is D-Tagatose, a naturally occurring simple sugar being developed as an oral treatment for glycemic control in patients with Type 2 diabetes and other indications. D-Tagatose has been recognized by the U.S. Food and Drug Administration (FDA) as a GRAS (Generally Recognized as Safe) substance for use in food and beverages since 2001.
Structurally, D-Tagatose is a naturally occurring stereoisomer of D-fructose, and resulted from the application of Biospherics’ expertise in chiral carbohydrate chemistry to create L-sugars that would retain their sweetness characteristics without being metabolized. Originally developed as a reduced-calorie sugar substitute, D-Tagatose is poorly absorbed in the small intestine, thus preventing the stimulation of insulin secretion and lowering blood glucose levels. D-Tagatose passes directly to the lower intestine, where it is fermented by bacteria to produce short-chain fatty acids and carbon dioxide. It is considered a prebiotic, promoting more favorable microbial flora in the colon.
Biospherics is running a Phase 2 clinical trial studying the dose-response effect of minimal doses of D-Tagatose on glycemic control in subjects with Type 2 diabetes under diet control and exercise. It is a six-month, multi-center, single-blinded, randomized parallel study. Preliminary results of the trial were encouraging, with the group receiving 7.5 grams of D-Tagatose averaging a 0.3% reduction in HbA1c (blood glucose level) versus the group receiving 2.5 grams, and the group receiving 5.0 grams of D-Tagatose averaging a reduction in HbA1c of 0.05% versus the 2.5 gram group. In addition, triglycerides (a measurement of fat in the bloodstream) were reduced by 59 mg/dl, low-density lipoproteins (LDL, or “bad” cholesterol) were lowered an average of 13 mg/dl and high-density lipoproteins (HDL or “good” cholesterol) were raised an average of 0.9 mg/dl. The overall LDL:HDL ratio of the subjects in the trial improved by 0.3.
D-Tagatose is currently being studied as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes in a double-blind, randomized Phase 3 study at 62 sites in the U.S. and India. The study is powered to detect a 0.5% reduction in HbA1c as its primary endpoint, with secondary endpoints establishing glucose, insulin and lipid profiles and measuring changes in body weight.

Spherix has intellectual property protecting D-Tagatose, with 2 issued U.S. patents and one patent pending. In addition, if approved, D-Tagatose is likely to receive at least five years of market exclusivity as a result of the Hatch-Waxman extension for new chemical entities

AugustaFriens: SPEX at .71 cents -- I am Holding based on the Phase news due by end of January 2011. Also, the daily chart is right on the 50dma and the weekly MACD about to cross. If SPEX gets to .80 + during the first week in January 2011 - expect this to be a major runner in January.