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Thread: SPEX - Spherix Inc. - NASDAQ

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    Default SPEX - Spherix Inc. - NASDAQ

    Naturlose (D-Tagatose) Efficacy Evaluation Trial (NEET)
    Verified by Spherix Incorporated, August 2009
    First Received: August 7, 2009 Last Updated: August 11, 2009 History of Changes
    Sponsor: Spherix Incorporated
    Information provided by: Spherix Incorporated
    Purpose
    The purpose of this trial is to evaluate the effectiveness and safety of Naturlose (Tagatose) for glycemic control in people with Type 2 diabetes who are not taking other medications for the condition and who are under diet control and exercise.

    The study will last approximately one year. HbA1c will be monitored every 2 months after entry into the study. Safety and tolerance for tagatose will be assessed every 2 months throughout the study. A total of 14 visits will be made to the study site.
    Condition Intervention Phase
    Type 2 Diabetes
    Drug: Tagatose
    Drug: Placebo
    Phase III

    Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
    Official Title: Effects of Naturlose (Tagatose) on Glycemic Control and Safety of Naturlose Over One Year in Subjects With Type 2 Diabetes Under Diet Control and Exercise

    Resource links provided by NLM:

    MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness
    U.S. FDA Resources

    Further study details as provided by Spherix Incorporated:

    Primary Outcome Measures:
    To evaluate a placebo-subtracted treatment effect of tagatose in glycemic control determined by a statistically significant decrease in hemoglobin A1c (HbA1c) levels. [ Time Frame: One Year ] [ Designated as safety issue: No ]

    Estimated Enrollment: 550
    Study Start Date: April 2007
    Estimated Study Completion Date: April 2010
    Estimated Primary Completion Date: March 2010
    (Final data collection date for primary outcome measure)

    NATURLOSE can be a Blockbuster drug !!!
    If this study results are good, we Can expect 100% jump in SPEX sheres price !!!!
    Now spex is 1,34......

    Last edited by giasone; 03-03-2010 at 05:04 AM.

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    Default tagatose-development-on-track

    Spherix (SPEX: 1.33 +0.03 +2.31%) reported financial results for the fourth quarter and full year 2009 on April 1, 2010. Total revenues for the fourth quarter were $0.3 million, in-line with our forecast. Revenues consisted of consulting fees from the company’s Health Sciences business. Total revenues for the full year 2009 were $1.4 million, up 32% from the full year 2008.

    The Health Sciences business provides technical and regulatory consulting services to biotechnology and pharmaceutical companies, as well as providing technical support for the company’s own R&D activities. During 2009, Health Sciences provided services to a total of 12 companies. Revenue from the top 5 customers accounted for 19%, 16%, 14%, 12% and 11% of total revenues. No other customer of the Health Science business accounted for more than 10% of total revenues.

    Net loss for the fourth quarter 2009 was $3.4 million, or -$0.21 per share. For the full year 2009, net loss totaled $9.1 million, or -$0.62 per share. Spherix exited 2009 with $9.4 million in cash and investments. We believe this is sufficient cash to fund operations through the completion of the ongoing phase III program testing D-tagatose as a treatment for type 2 diabetes.

    Phase III Enrollment Completed

    Enrollment has completed in the phase III NEET (Naturlose Efficacy Evaluation Trial) program in January 2010. Preliminary blinded data released by the company in November 2009 demonstrated a significant reduction in variability of HbA1c levels. The data also confirmed that the current protocol is sufficiently powered to achieve the statistical significance as per the primary endpoint of differences between control and D-tagatose in HbA1c.

    The blinded analysis noted that the results of the secondary variables, LDL, HDL, triglycerides and BMI, are in agreement with that of the HbA1c results. The blinded interim analysis also looked at a summary of HbA1c “responders” (i.e., subjects achieving HbA1c target of <6.5%). 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 received placebo.

    Management’s goal is to complete the ongoing NEET program late 2010, and then file for U.S. FDA approval during the first half of 2011. We expect management to secure a commercialization partnership for D-tagatose around the NDA filing.

    With a current market capitalization of only $21 million, we believe the shares are significantly undervalued. An effective and safe phase III type-2 diabetes drug is a highly coveted asset in the pharmaceutical industry, and D-tagatose looks like the real thing. In fact, we would not be surprised to see an outright acquisition by a larger organization instead of a licensing or commercialization partnership. We believe this could occur at a value of $60 million or higher, yielding a near-term fair-value target of $3.50 per share.
    Last edited by giasone; 08-27-2010 at 11:50 AM.

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    Abstract from...
    "Spherix Announces Second Quarter 2010 Financial Results"

    .........."Actively seeking a strategic relationship with a pharma company for the continued development of D-tagatose as a treatment for Type 2 diabetes
    Conducted additional rounds of Medical Advisory Board meetings to provide clinical guidance for the development program for D-tagatose as a treatment for Type 2 diabetes and potential as a triglyceride therapy
    Announce efficacy results of the Phase 3 trial for the treatment of Type 2 diabetes by mid-September 2010 and anticipated completion of the Phase 2 Dose Range trial by the end of 2010

    Rodman and Renshaw Global Investment Conference, Sept. 12-15, New York, NY

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    Default

    They have their annual shareholder meeting tomorrow.

    One of the amendments is:

    " (2) For purposes of complying with NASDAQ Marketplace Rule 563(d) in connection with one or more capital-raising transactions, to authorize the Company to issue up to 15,000,000 shares of common stock (including preferred stock, options, warrants, convertible debt or other securities exercisable for or convertible into common stock) for aggregate consideration of not more than $12,000,000 million in cash and at a price not less than 80% of the market price of the Company’s common stock at the time of issuance, with such issuances to occur, if at all, within the three-month period commencing on the date of the approval of this proposal by the stockholders, and upon such terms as the Board of Directors shall deem to be in the best interests of the Corporation."

    http://www.sec.gov/Archives/edgar/da...45_2def14a.htm

    watch out

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    Ciao Pslice84 ! Excuse my English !

    Yes thanks but I knew..... my entry price is low enough. I can afford to risk the wait ....
    Now, Everything 's guessing when the option will be exercised...
    Should they do so after the announcement of the results!?
    What do you think about?

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    Spex surge on phase 3 results !!!

    Yes!

    Spherix Announces Statistically Significant Results in Phase 3 Study With D-tagatose in Type 2 Diabetes


    Statistically Significant Reductions in HbA1c Achieved at 2, 6, and 10 Months; Reduction in HbA1c Increases Over Time
    BETHESDA, Md., Oct. 7 /PRNewswire-FirstCall/ -- 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.
    *PP = Per-Protocol; ITT = Intent-to-Treat; LOCF = Last Observation Carried Forward
    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.
    Triglycerides
    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.
    NEET Trial Design
    NEET is a double-blind, placebo-controlled trial with 356 treatment-nave patients randomized to receive 15 grams of D-tagatose three times daily with meals for a period of up to one year as an adjunct to diet and exercise, or a placebo three times daily with meals for up to one year as an adjunct to diet and exercise. Patients were treated for more than 10 months, and HbA1c levels were measured at two, six and 10 months after enrollment into the trial. The average HbA1c level at the time of entering the trial was 7.5%. The NEET inclusion criteria for HbA1c in patients were screening (visit 1) and randomization (visit 2) values between 6.6% and 9.0%.
    A modified Intent-To-Treat (ITT) definition was used in NEET. The modified ITT population consisted of all randomized subjects who received at least one dose of their randomized treatment and had at least one post-treatment visit evaluating efficacy. The PP population consisted of all ITT subjects who had 80% compliance with medication for 75% of the dosing time points and had no major protocol violations. Last Observation Carried Forward (LOCF), a method in which the last results before a subject drops out of the trial are carried forward to the end of the trial, was used in the ITT population when data were missing due to circumstances such as loss to follow-up. The trial was conducted at 34 sites in the U.S. and 23 sites in India. The final patient numbers were 172 in the drug arm and 184 in the placebo arm (ITT), and 85 in the drug arm and 119 in the placebo arm (PP). A total of 102 patients were enrolled at U.S. sites, and 254 patients were enrolled at India sites. The trial was initially powered by design to detect a reduction in HbA1c of 0.5%, but the variance in HbA1c at each time point was smaller than the original design assumption, enabling a smaller change in HbA1c to be detected with statistical significance. Secondary endpoints included glucose measures, insulin measures, lipid profiles and changes in body weight.

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