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Positive Clinical Trial Results were concluded for Type 2 Diabetes. This stock is a buy right now. It is very low priced. Trading was halted today. Expect modest returns tomorrow October 8th. This is a competitive market for Diabetes Drugs. Hopefully, getting FDA Approval soon could allow a gain in Market Share.
-Statistically Significant Reductions in HbA1c Achieved at 2, 6, and 10 Months; Reduction in HbA1c Increases Over Time
BETHESDA, Md., Oct. 7 /PRNewswire
Spherix Incorporated (Nasdaq: SPEX), 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 3 study of D-tagatose as a monotherapy in Type 2 diabetes showed a statistically significant (p<0.05) reduction in HbA1c levels of 0.4% at 10 months in relatively healthy people with diabetes (U.S. ITT LOCF, n=101 and Global PP, n=92)*. The reduction was even more pronounced among PP patients treated in the U.S., and the reduction in HbA1c generally increased over the 10 months patients were treated (see Table 1).
The NEET (Naturlose® Efficacy Evaluation Trial) data show that D-tagatose was more effective in the U.S. population than in the Indian population, as the PP patients in the U.S. who were treated with Dtagatose had a reduction in HbA1c of 0.4% at two months, 0.6% at six months and 1.1% at 10 months on therapy (p<0.05). Patients in the study had a low average randomization HbA1c of 7.5% globally. An HbA1c level of 6% or below is considered normal. An 8% level is considered high. The American Diabetes Association recommends a goal of reducing HbA1c to 7% or below in people with diabetes.
"These are promising results and we are pleased with the significant drop in HbA1c levels among patients treated with Dtagatose. As a monotherapy in a patient population with mild disease, this achievement is even more compelling," said Dr. Claire Kruger, Chief Executive Officer of Spherix. "We believe that further development in the Type 2 diabetes indication is merited, and we look forward to engaging a partner to continue this work." John Amatruda, M.D., a drug-development executive who was formerly Senior Vice President and Franchise Head, Diabetes and Obesity, at Merck Research Laboratories and is now an advisor to Spherix, summarized clinical trial expectations.
According to Dr. Amatruda, "Decreases in HbA1c with drugs to treat Type 2 diabetes are dependent on the baseline HbA1c; the higher the baseline the greater the decrease (Bloomgarden et al, Diabetes Care, Volume 29 Number 9 September 2006). Generally, one would not expect large decreases in HbA1c if the mean HbA1c at randomization is 7.5%." Patients with HbA1c levels between 8.0% and 9.0% globally, which are at the high end of the inclusion criteria, showed 0.7% reduction on D-tagatose at 10 months of therapy (PP, not shown in table). This occurred in a subpopulation of patients using the drug per protocol, but was not with statistical significance (p=0.09) due to the small number of patients (n=30) with HbA1c values at those levels. "We are very encouraged by the response seen in patients with poorer control of blood sugar as measured by HbA1c in the NEET study," stated Dr. Robert Lodder, President of Spherix.
Tolerability data are still being analyzed, but the number of patients with one or more treatment-emergent adverse events in the active group (163) was comparable to those reported in the placebo group (166). No serious adverse event was deemed to be treatment related. No episodes of hypoglycemia or pancreatitis were reported in NEET. Next Steps Spherix intends to submit a detailed analysis of the Phase 3 data to a peer-reviewed medical journal after the complete study report is received later this year. Spherix will also post the final trial results on the public NIH ClinicalTrials.gov website as required by law.
In addition, Spherix will begin discussions with pharmaceutical companies and participate in two upcoming industry meetings: BioPartnering Europe, October 11-12 in London; and the Windhover Therapy Area conference, November 3-4 in Boston.
Because of the small number of patients enrolled in the NEET diabetes trial with triglyceride levels of 200 to 500 mg/dl, and a lack of patients with triglyceride levels above 500 mg/dl, it was not possible to conduct statistical analyses on that secondary endpoint in the current trial. Dr. Lodder's previous research in an animal model of dietary-induced hyperlipidemia demonstrated an effect of D-tagatose on triglycerides, VLDL, LDL in blood, and on atherosclerosis in arterial walls. Animals consuming Dtagatose exhibited a statistically significant five- to six-fold reduction in triglycerides compared with animals consuming sucrose. "We plan to continue with our stated goal of investigating the development of D-tagatose as a therapy for reduction of triglycerides," Dr. Lodder said.
BETHESDA, Md., Sept. 15 /PRNewswir/
Spherix Incorporated (Nasdaq CM: SPEX), 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 the Company's pharmaceutical product, D-tagatose, has been selected as one of the top 10 most promising cardiovascular/metabolic therapies in development. The selection was made by an independent committee assembled by Windhover Information, a leading provider of business information products and services to senior executives in the pharmaceutical, biotechnology, and medical device industries and publisher of IN VIVO and Start-Up. Spherix has been invited to present its data on D-tagatose at Windhover's Therapeutic Alliances Cardiovascular Conference in Boston on November 3-4, 2010.
"Recognition of D-tagatose by Windhover Information underscores the value we see in it as potential therapy for Type 2 diabetes," said Dr. Claire L. Kruger, Chief Executive Officer of Spherix. "Windhover's Therapeutic Alliance Partnerships is the industry's most targeted, efficient, strategic-level partnering meeting for life science companies seeking partnerships in the cardiovascular and metabolic therapeutic areas."
The Top 10 selection was made by an independent committee headed by Marc Wortman, Ph.D., a regular contributor to Windhover's Start-Up, and Jun Huangpu, Ph.D., MBA, founder of Cobbs Creek Healthcare LLC. The committee evaluated hundreds of compounds currently in development for the treatment of cardiovascular disease and metabolic disorders.
According to Windhover, evaluation criteria include:
Unmet medical need
Multi-level marketing opportunities
Potential for new opportunities beyond initial indications
Diversity of indications
History of the molecule and drug
Data from the Naturlose (D-tagatose) Efficacy Evaluation Trial (NEET) trial are currently being analyzed. Spherix plans to announce the results of the Phase 3 trial in the coming weeks. NEET was initiated in 2007 and is a double-blind, placebo-controlled study designed to evaluate the safety and efficacy of D-tagatose as a monotherapy as an adjunct to diet and exercise. The primary endpoint is change in HbA1c, with secondary endpoints that include triglycerides, glucose and insulin profiles, and changes in body weight.
Spherix is seeking a partner to complete clinical testing of D-tagatose in diabetes and, pending successful results, submit regulatory applications in the US and/or Europe. Based on new, more stringent FDA guidelines for diabetes drug safety evaluation, Spherix executives announced in June that the Company has chosen not to fund additional clinical trials in diabetes and will seek a partnership in order to bring D-tagatose to market. To date, there do not appear to be any significant safety concerns in the Phase 3 trial.
Spherix has announced that it intends to initiate development, on its own, of D-tagatose for treating hypertriglyceridemia levels, pending results of the NEET trial. The effect on triglycerides is a secondary endpoint of the current Phase 2 and Phase 3 trials for diabetes.
D-tagatose, a naturally occurring sugar, is a low-calorie, full-bulk sweetener previously approved by the Food and Drug Administration ("FDA") as a GRAS (Generally Recognized As Safe) food ingredient. It is a true sugar that looks, feels, and tastes like table sugar. During human safety studies supporting food use, the Company discovered and patented a number of health and medical uses for D-tagatose. The Company holds the patents for use of D-tagatose as a treatment for Type 2 diabetes. The use patents for D-tagatose as a treatment for Type 2 diabetes expire in 2012, not including extensions. If approved for use as a drug by the FDA, 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 years of market exclusivity in the European Union, if approved by the European Medicines Agency (NYSEMKT:EMA).
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 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 http://www.spherix.com/.
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Disclosure: Long Spherix