Spherix Announces Positive Phase 2 Study Results

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Wed Jun 24, 2009 1:26pm EDT

Preliminary Data Demonstrates Reduction of HbA1c Levels With Doses an Order of
Magnitude Lower than the Dose Used in the Current Phase 3 Trial.

BETHESDA, Md., June 24 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq
CM: SPEX), an innovator in biotechnology for diabetes therapy, and a provider
of technical and regulatory consulting services to food, supplement,
biotechnology and pharmaceutical companies, today announced positive
preliminary results from a Phase 2 clinical trial of its novel compound,
Naturlose(R) (D-tagatose), in the treatment and management of Type 2 diabetes.
 The Phase 2 trial is expected to be completed in early 2010.

In the ongoing single-blind study designed to establish the minimum dose of
Naturlose capable of causing a beneficial effect, Naturlose is administered
orally with meals, three times daily (TID) at three different doses:  2.5,
5.0, and 7.5 g. The comparator is the 2.5 g dose.  The primary endpoint for
the study is reduction in HbA1c after 6 months on the drug.  After 6 months on
drug, the patients in the 7.5 g group experienced an average reduction of 0.3%
in HbA1c from the HbA1c of the 2.5 g group.  At that same 6-month point, the
5.0 g group averaged a reduction in HbA1c of 0.05% from the 2.5 g group. 
Naturlose appears to begin showing an effect on HbA1c within the range of
doses selected for this minimum-dose study.  The ongoing Phase 3
double-blinded study of efficacy is being conducted at a 15 g dose (TID), and
is powered to detect a 0.5% reduction in HbA1c.

Over the course of the Phase 2 trial, Naturlose also decreased the average
serum triglycerides of the patients by -59 mg/dl by the end of the first month
on therapy, a decrease from baseline that remained at -41 mg/dl by the end of
the 6 months of the trial.  Naturlose also decreased serum LDL by an average
-13 mg/dl by the end of the first month on therapy, while serum HDL was
essentially unchanged (+0.9 mg/dl). The LDL:HDL ratio was improved for two of
the three dose groups by an average of 0.3.

"The results of this ongoing Phase 2 study are encouraging and reaffirm our
belief that Naturlose may be a valuable treatment option for patients with
Type 2 diabetes," said Dr. Claire Kruger, CEO of Spherix.  "Naturlose,
administered at three separate low doses, proved to be effective for at least
6 months in reducing HbA1c, a key indicator of Type 2 diabetes that monitors
glycated hemoglobin in the blood.  These data, combined with the fact that
Naturlose is a naturally occurring compound with no known contraindications to
current Type 2 diabetes treatments, continues to lead us to believe that there
will likely be a place for Naturlose in the treatment regime as either a
stand-alone or an adjunct therapy.  In addition, the effect on serum
lipoproteins may lead to a role for Naturlose in the treatment of
atherosclerosis and the metabolic syndrome."

Phase 2 Study Design

This phase 2 single-blind, prospective, randomized, multicenter study
evaluated the minimum oral dose of Naturlose capable of causing a beneficial
effect on HbA1c, and the safety of such doses. Naturlose was administered
orally with meals (TID) at three different doses, 2.5, 5.0, and 7.5 g. 
Patients were required to pass specific inclusion criteria at screening and at
baseline, including an HbA1c level at screening and baseline between 6.6% and
9.0%.  The baseline visit followed an 8-week run-in period in which patients
were instructed to follow a weight-maintaining diet and a daily exercise
program under the supervision of the investigator.  The run-in period was
designed to compensate for the effect of diet and exercise on the estimated
effectiveness of the drug.  The treatment duration was six months and 38
patients have been randomized to one of the three doses to date. Patients with
a current or recent history (within the prior 3 months) of treatment with any
oral or injectable anti-diabetic treatment were excluded from the study, as
well as any having one or more episodes of severe hypoglycemia within six
months prior to entry into the study, or currently diagnosed as having
hypoglycemia unawareness.

In this trial, Naturlose was safe and well tolerated.  Low rates of
treatment-related adverse events were noted at all doses.  The most common
adverse events reported in the trial were mild and gastrointestinal in nature.


Prior Studies with Naturlose

A recent controlled animal study demonstrated that, in comparison to sucrose,
equivalent substitution of Naturlose as dietary carbohydrate results in less
obesity, hyperglycemia, hyperlipidemia, and atherosclerosis (Police SB, Harris
JC, Lodder RA, Cassis LA. Effect of diets containing sucrose vs. D-tagatose in
hypercholesterolemic mice. Obesity. 2009 Feb;17(2):269-75.). A novel finding
in this study was that atherosclerotic lesions detected in TAG-fed mice were
composed of increased collagen, indicative of a more stable plaque phenotype. 
The results suggest that, in addition to minimizing the extent of
atherosclerosis from carbohydrate consumption, a diet enriched in tagatose may
favor a more stable plaque phenotype less likely to cause stroke or myocardial
infarction.

Prior Clinical Trials with Naturlose

Eight healthy individuals and eight individuals with type 2 diabetes underwent
separate 3-hour oral glucose and tagatose tolerance tests.  The subjects were
also given 75 g of tagatose followed 30 minutes later by 75 g of glucose.
Between test days, participants received 10 g of tagatose per day.  Ingestion
of the tagatose load (75 g) caused no increase in plasma insulin or glucose
concentrations in either healthy or diabetic individuals. (Donner TW, Wilber
JF, Ostrowski D.  D-Tagatose, a novel hexose: Acute effects on carbohydrate
tolerance in subjects with and without type 2 diabetes. Diabetes Obesity Metab
1999 I 5 285-291)

A dose and time-of-administration study was conducted to verify the dosing
plan to be used in the phase 3 trial. It was a randomized, open-label, 3 x 3
factorial design for an instant mashed potato load, and a 2 x 3 factorial
design for a glucose load in which each subject participated in 11 separate
2-h meal or glucose tolerance tests.  A total of 33 non-diabetic, healthy
subjects (18 males and 15 females) aged 18-44 years who had satisfied the
screening evaluation were enrolled into the study.  Treatment with tagatose,
whether it was at a dose of 10 g or 15 g, whether it was taken with or before
the meal or glucose load, blunted the rise of plasma glucose (Yongming Lu,
Gilbert Levin, Thomas Donner.  Tagatose, a New Anti-Diabetic and
Obesity-Control Drug.  Diabetes, Obesity and Metabolism.  10, 2008, 109-134.)

About Type 2 Diabetes

Type 2 diabetes mellitus (T2DM) is a disease that is characterized by elevated
blood glucose in the context of insulin resistance and comparative insulin
deficiency. While T2DM 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.
(7.8% of the population) with diabetes, and 17.9 million cases have been
diagnosed.  Of the diagnosed diabetes cases, 90% are type 2. As T2DM
prevalence rates doubled between 1990 and 2005, the CDC characterized the
increase as an epidemic. Customarily considered a disease of adults, T2DM is
increasingly being diagnosed in children in correlation to increasing juvenile
obesity rates.

About Naturlose

Spherix holds patents on the use of Naturlose as a drug to treat diabetes. 
Naturlose is D-tagatose, which occurs naturally in small amounts in dairy
products. It is a highly soluble white crystal or powder, can be produced with
a physical bulk similar to ordinary table sugar, and is 92% as sweet. In the
U.S., based on over 10 years of animal, human, and other relevant use and
safety data, Naturlose was determined to be Generally Recognized As Safe
(GRAS) for use in foods as regulated by the Food Additives Amendment to the
Federal Food, Drug, and Cosmetic Act. Naturlose has been approved as a "novel
food ingredient" in the European Union (EU) without any restriction on usages.
 Nutraceutical or functional foods are foods with health-promoting or dietary
management properties beyond the basic function of supplying nutrients and are
a growing segment of the industry due to their increasing popularity with
health-conscious consumers.

About Spherix

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 currently running a Phase 3 clinical trial to study the use of
Naturlose as a treatment for Type 2 diabetes.  Its Spherix 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.  For more
information, please visit www.spherix.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to
provisions of Section 21E of the Securities Exchange Act of 1934.  Investors
are cautioned that such statements in this release, including statements
relating to planned clinical study design, regulatory and business strategies,
plans and objectives of management and growth opportunities for existing or
proposed products, constitute forward-looking statements which involve risks
and uncertainties that could cause actual results to differ materially from
those anticipated by the forward-looking statements.  The risks and
uncertainties include, without limitation, risks that product candidates may
fail in the clinic or may not be successfully marketed or manufactured, we may
lack financial resources to complete development of Naturlose, the FDA may
interpret the results of studies differently than us, competing products may
be more successful, demand for new pharmaceutical products may decrease, the
biopharmaceutical industry may experience negative market trends, our
continuing efforts to develop Naturlose may be unsuccessful, our common stock
could be delisted from the Nasdaq Capital Market, and other risks and
challenges detailed in our filings with the U.S. Securities and Exchange
Commission, including our current report on Form 8-K filed on October 10,
2007.  Readers are cautioned not to place undue reliance on any
forward-looking statements which speak only as of the date of this release. 
We undertake no obligation to publicly release the results of any revisions to
these forward-looking statements that may be made to reflect events or
circumstances that occur after the date of this release or to reflect the
occurrence of unanticipated events.

SOURCE  Spherix Incorporated

Investor Relations, +1-301-897-2564, info@spherix.com
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