Oramed Pharmaceuticals Inc.
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hier noch die aktuelle sec eintragung :
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11505673
na also.
Title: Oramed Reports Additional Phase IIb Oral Insulin Study Data Demonstrating Significant Lowering of Glucose Levels vs Placebo
Date(s): 28-Jul-2016 8:15 AM
For a complete listing of our news releases, please click here
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, today reported additional data from the recently concluded Phase IIb trial of its oral insulin capsule ORMD-0801 in adults with type 2 diabetes. The data indicate a statistically significant lowering of glucose relative to placebo across several endpoints. Oramed had previously announced positive topline data showing the study successfully met its primary efficacy and safety endpoints.
"ORMD-0801 was safe and efficacious in reducing blood glucose endpoints with a promising clinically meaningful reduction in the mean 24-hour blood glucose," said Dr. Roy Eldor, Oramed's Chief Medical Director, "We look forward to preparing the groundwork for a Phase III trial as we continue to bring this revolutionary product to market."
The primary objective of the study was to evaluate the nighttime glucose lowering effect and safety of ORMD-0801 compared to a placebo. Excessive production of glucose at night is a significant challenge in diabetes management. Reducing nighttime blood glucose levels can significantly slow down the progression of diabetes and its life threatening comorbidities.
In the study, the mean nighttime glucose showed a significant difference in mean change from run-in (13.70 mg/dL for placebo vs. 1.66 mg/dL for the pooled ORMD-0801 arms with a p= 0.0117). ORMD-0801 was safe and well tolerated, with no drug related serious or severe adverse events and no statistically significant differences in laboratory values or vital signs.
Other secondary and exploratory objectives of the study included evaluating the effect of ORMD-0801 on mean 24-hour glucose, fasting glucose, and daytime glucose. The mean 24-hour glucose showed a highly significant difference in mean change from run-in (13.26 mg/dL for placebo vs. -0.32 mg/dL for ORMD-0801, p <0.0001). The mean fasting glucose showed a highly significant difference in mean change from run-in (15.95 mg/dL for placebo vs. -0.41 mg/dL for ORMD-0801, p <0.0001). The mean daytime CGM glucose showed a highly significant difference in mean change from run-in (11.88 for placebo vs. 0.88 for ORMD-0801, p= 0.0010).
There was a statistically significant difference in change in HbA1c at Day 29 (0.20% for placebo vs.-0.01% for ORMD-0801, p= 0.0149). It is important to note that due to the kinetics of change of HbA1c, a four week study is insufficient to fully appreciate the potential positive impact of ORMD-0801 on HbA1c.
ORMD-0801 did not show a significant difference in change in morning fasting serum insulin, C-Peptide, or triglycerides.
A conference call on the results of the Phase IIb study will be held today, July 28, 2016, at 11:00 AM ET. Presentation slides to be used for the conference call are available at: http://www.oramed.com.
http://www.biospace.com/news_story.aspx?StoryID=427481&full=1
onka : ist das nun ein weiterer meilenstein zum eintritt in den milliarden markt für die insulin pille von oramed ?
Anmerkung: Die Präsentation sieht ein wenig lieblos aus und ist noch nicht von einer News begleitet. Vielleicht ist das ein positives Zeichen?!
imo wieder bei 8,450,55 (6,96 %)..
vllt klapps ja morgen oder in einer woche oder in einem monat oder......in 10j.
Zeitpunkt: 29.07.16 08:56
Aktion: Löschung des Beitrages
Kommentar: Moderation auf Wunsch des Verfassers
...These results suggest we will observe a further and clinically meaningful reduction in A1C in longer studies.
....In this study, no clear dose response was observed. While it may be due to lack of clear pharmacokinetic differentiation between the two dose levels studied it may very well suggest a mechanistic effect of a liver directed insulin. This would align with the sustained daylong anti-hyperglycemic effect observed in this study. We are currently planning a short dose response study to get a better understanding of this phenomenon and to fine tune our selected doses as we move towards our planned Phase III trial.
Concluding my remarks, I want to say that we are truly encouraged by these results and see a clear path forward towards an end of Phase II meeting with the FDA and initiation of our Phase III studies. While currently under development, our Phase III program will focus on safety and long-term A1C lowering efficacy, and will include both active comparator and placebo controlled trials.
allso meiner ansicht steht alles auf grün.
Bisher läuft alles nach Plan...nur der Kurs nicht :-(
http://www.nasdaq.com/press-release/...yment-from-htit-20160802-00685
Oramed Receives Additional $4 Million Milestone Payment From HTIT
Totaling $25.5 M in payments from HTIT received to date
schon ein bizzel komisch !
...
Bottom line, if the upcoming results for Novo Nordisks Phase II oral insulin therapy are negative and Oramed proceeds to Phase III, there may be a bidding war over Oramed in a mad dash to keep the current diabetes business model alive. That means the final results of this Novo Nordisk Phase II trial for oral insulin could have profound effects on Oramed shares and its shareholders, even more than a first-hand Oramed data readout.
http://...disk-adr-nasdaqnvo-vs-oramed-pharmaceuticals-inc-nasdaqormp
sehr schöner und ermutiger bericht über oramed und novo....unter diesen gesichtspunkten sitzen wir also auf einem möglichen pulverfass.....kurstechnisch...!!