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Regulus Therapeutics Inc
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14:07:59
www.marketwatch.com/story/...p-c-drug-trial-results-2016-02-17
+2,84
+54,89 %
14:07:59
www.marketwatch.com/story/...p-c-drug-trial-results-2016-02-17
Regulus Therapeutics Inc. RGLS, +26.11% stock surged nearly 40% in active pre-market trade Wednesday after the company reported positive results from a phase 2 study of a Hepatitis C treatment. Regulus said it will accelerate the Hepatitis C drug's development, given what CEO and President Paul Grint called its "promising potential to shorten treatment regimens." The company's RG-101 drug was injected at the beginning and end of the four-week treatment regimen, with patients also taking anti-viral agents throughout the month-long period. Nearly all of the 38 patients evaluated through eight weeks of follow-up saw the Hepatitis C virus reduced to very low levels, and all the patients saw the same result through 12 weeks of follow-up. Additional results from all 79 patients in the trial should emerge late in the second quarter, the company said.
Gute Ergebnisse:
LA JOLLA, Calif., Feb. 17, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced interim results from one of the company's ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV). The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral agents Harvoni®, Olysio®, or Daklinza™. The study enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio® arm, n=27, Daklinza™ arm, n=25). Thirty-eight patients have been evaluated through 8 weeks of follow up. Ninety-seven percent of those patients (37/38) had HCV RNA viral load measurements below the limit of quantification. To date, RG-101 has been generally well tolerated with the majority of adverse events considered mild or moderate, and with no study discontinuations. For those patients through 12 weeks of follow-up, 100% remained below the limit of quantification (14/14). The primary endpoint analysis (12 week follow up) for all 79 patients in the study are anticipated to be reported in late Q2 2016.
LA JOLLA, Calif., Feb. 17, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced interim results from one of the company's ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV). The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral agents Harvoni®, Olysio®, or Daklinza™. The study enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio® arm, n=27, Daklinza™ arm, n=25). Thirty-eight patients have been evaluated through 8 weeks of follow up. Ninety-seven percent of those patients (37/38) had HCV RNA viral load measurements below the limit of quantification. To date, RG-101 has been generally well tolerated with the majority of adverse events considered mild or moderate, and with no study discontinuations. For those patients through 12 weeks of follow-up, 100% remained below the limit of quantification (14/14). The primary endpoint analysis (12 week follow up) for all 79 patients in the study are anticipated to be reported in late Q2 2016.
Neuer Wirkstoff gegen die HCV-Mikro-RNA miR-122
Die leberspezifische Mikro-RNA miR-122 sorgte bereits vor einigen Jahren als vielversprechendes neues Angriffsziel für die Entwicklung eines HCV-spezifischen Medikaments für großes Aufsehen (11). Das damals eingesetzte anti-miR-122-Wirkstoff Miravirsen wurde jedoch von Roche bislang (oder endgültig?) nicht über Phase-II hinaus weiterentwickelt.
Entsprechend groß war nun das Interesse an der GalNAc-konjugierten anti-miR-122-Substanz namens RG-101 der Firma Regulus. Nach einmaliger subkutaner Gabe in unterschiedlicher Dosis lag die HCV-RNA bei insgesamt 6/28 Patienten (1x GT1, 2x GT3 und 3x GT4) noch 28 Wochen später unter der Nachweisgrenze (12). Weitere Studienergebnisse zur Kombination aus RG-101 mit bereits zugelassenen DAAs werden in Kürze erwartet.
Die leberspezifische Mikro-RNA miR-122 sorgte bereits vor einigen Jahren als vielversprechendes neues Angriffsziel für die Entwicklung eines HCV-spezifischen Medikaments für großes Aufsehen (11). Das damals eingesetzte anti-miR-122-Wirkstoff Miravirsen wurde jedoch von Roche bislang (oder endgültig?) nicht über Phase-II hinaus weiterentwickelt.
Entsprechend groß war nun das Interesse an der GalNAc-konjugierten anti-miR-122-Substanz namens RG-101 der Firma Regulus. Nach einmaliger subkutaner Gabe in unterschiedlicher Dosis lag die HCV-RNA bei insgesamt 6/28 Patienten (1x GT1, 2x GT3 und 3x GT4) noch 28 Wochen später unter der Nachweisgrenze (12). Weitere Studienergebnisse zur Kombination aus RG-101 mit bereits zugelassenen DAAs werden in Kürze erwartet.
www.streetinsider.com/Corporate+News//...didates/12317291.html
Ganz schön runter! Zum Glück bin ich hier mit ± 0 raus ...
www.finanzen.net/analyse/...c_Hold-Needham__Company_LLC_600945
ich den Absturz für übertrieben!
regulusrx.com/programs/clinical-pipeline/
regulusrx.com/programs/clinical-pipeline/
seekingalpha.com/article/...6-results-earnings-call-transcript
www.finanzen.net/analyse/...bush_Morgan_Securities_Inc__604813
www.nasdaq.com/de/symbol/rgls/real-time
We also raised $46 million which extends our runway through Q1 2019 providing the necessary capital to get us to keep program milestones all of which I believe position us for longer term success.
seekingalpha.com/article/...-results-earnings-call-transcript
seekingalpha.com/article/...-results-earnings-call-transcript
Könnte was werden schauen wir mal bin rein mit SL
Gestern im Amiland gekauft.
Gestern im Amiland gekauft.
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