SPHERIX ANNOUNCES POSITIVE INTERIM RESULTS IN PHASE 3 TRIAL OF NOVEL, ORAL COMPOUND FOR TYPE 2 DIABETES
Medical Advisory Board of Diabetes Experts Formed to Assist in Late-Stage Development
Bethesda, MD, November 16, 2009 /PRNewswire/ - 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 interim Phase 3 clinical results for the planned review of the NEET (Naturlose (D-tagatose) Efficacy Evaluation Trial) trial of D-tagatose in drug naïve patients.
Results of the blinded interim data analysis of the Phase 3 trial demonstrate a significant reduction in variability of HbA1c levels, the primary endpoint of the trial. The observed data to-date indicate that the change in variability of HbA1c from baseline is favorable, and that the current sample size gives the study sufficient power to achieve the statistical significance for protocol defined differences between control and D-tagatose in HbA1c when the study reaches the planned number of patients completing treatment.
"The interim results and overall study progress are very encouraging," said Dr. Claire Kruger, Chief Executive Officer of Spherix. "The interim analysis results are significant because they indicate that if this study continues as anticipated, results will support the efficacy and safety of D-tagatose as a new and important therapy for Type 2 diabetes. We are particularly pleased that the interim analysis of blinded pooled data from the NEET trial has established that the statistical significance for the pre-specified change in HbA1c, 0.5%, can be achieved with the current sample size."
The analysis noted that the results of the secondary variables, LDL, HDL, triglycerides, and body mass index (BMI), are very striking and are in agreement with that of the HbA1c results. These results demonstrate a significant decrease in the mean BMI at all time points evaluated compared to baseline. A consistent decrease of BMI and serum triglycerides was observed at each visit. A statistically significant reduction in HDL and LDL was also seen compared to baseline.
"Some of the currently marketed drugs to control glucose levels may cause patients with Type 2 diabetes to experience significant discomfort, and develop serious side effects, including cardiovascular disease. We believe our therapeutic approach has the potential to offer patients and clinicians an alternative for achieving their therapeutic goals without some of the attendant risks of currently available medications," said Dr. Claire Kruger.
In addition to the power calculation, a summary of HbA1c "responders" (i.e., subjects achieving HbA1c target of <6.5%) was in the interim analysis report. NIH Medline Plus states that, in general, an HbA1c of 6% or less is normal, and diabetic patients should try to keep their HbA1c level at or below 7%. The NEET protocol sets an HbA1c lower limit of 6.6% for randomization into the trial, and an upper limit of 9%. At the time of the interim analysis, not all subjects had finished the entire treatment course of this trial; therefore the number of responders was different for different months of therapy. The incidences of responders achieving an HbA1c target of <6.5% at 1, 2, 4 and 6 months of treatment were 4%, 13%, 19% and 18% respectively. Because the trial is randomized 1:1 in terms of drug and placebo, approximately 50% of the patients receive the placebo treatment.
The interim analysis is a pooled, blinded analysis, conducted by an independent statistics and regulatory consulting firm, and there is no statistical penalty. The NEET trial is an ongoing double-blind, placebo-controlled clinical study, designed to evaluate the safety and efficacy of D-tagatose for the management of Type 2 diabetes. Pending continuing positive study results and overall progress, Spherix remains on target to complete the Phase 3 clinical trial for D-tagatose and submit a New Drug Application (NDA) in 2010.
In October 2009, Spherix formed a Medical Advisory Board of ten experts in the field of diabetes and metabolic diseases to provide guidance for scientific and clinical development for D-tagatose. An early D-tagatose researcher and member of the newly formed Medical Advisory Board, Thomas W. Donner, M.D., Associate Professor of Medicine, University of Maryland, and Director of the Joslin Diabetes Center, commented following the first meeting of the Board, "Type 2 diabetes is at epidemic levels in the United States. We are encouraged by previous studies investigating D-tagatose's potential to reduce HbA1c and by its unique safety profile and acceptance by patients."
Joshua L. Cohen, M.D., also a member of Spherix's Medical Advisory Board, and Associate Professor of Medicine, Division of Endocrinology and Metabolism, The George Washington University Medical Center, commented, "Physicians need additional drugs in our armamentarium to treat Type 2 diabetes. Because it is already classified as Generally Recognized As Safe (GRAS) for use as a sweetener in food, D-tagatose is an exciting Phase 3 candidate for fighting diabetes and would be a new first-in class agent. We look forward to providing Spherix with advice and support to advance its clinical development."
About NEET Study
The ongoing double-blind, placebo-controlled NEET study is designed to evaluate the safety and efficacy of D-tagatose as monotherapy over the dosing period and as an adjunct to diet and exercise. The study is powered to detect a 0.5% change in HbA1c as its primary endpoint, with secondary endpoints establishing glucose, insulin and lipid profiles and measuring changes in body weight. The primary efficacy analysis will compare the change in HbA1c in patients receiving D-tagatose vs. placebo. The study is currently underway at more than 40 clinical research sites in the USA and India, and seeks to complete 332 patients. GI discomfort was the most common adverse event, with symptoms that were rare, mild and transient in nature at the beginning of the treatment period.
D-tagatose is a novel and natural oral agent being developed as an oral, monotherapy treatment for glycemic control in patients with Type 2 diabetes. D-tagatose prevents the stimulation of insulin secretion, avoiding beta cell exhaustion and naturally lowers blood glucose levels. The net effect is to shift or control blood sugar, HbA1c, and body weight at or closer to normal, healthy levels. D-tagatose has an established safety profile as an artificial sweetener and 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. Spherix has intellectual property protecting D-tagatose, with two 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.
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.
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 D-tagatose as an oral, monotherapy treatment for patients with 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.
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.