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May 22, 2014
08:20 EDTRDHLRedHill Biopharma announces FDA clearance for Phase III study with RHB-102
RedHill Biopharma announced that the FDA has allowed the initiation of the company's planned Phase III clinical study for the treatment of a new, undisclosed indication with RHB-102, an extended release oral pill formulation of the antiemetic drug ondansetron. RedHill plans to begin enrolling patients for the Phase III study during Q3. The double-blind placebo-controlled Phase III study is planned to be conducted in eight clinical sites in the U.S. and will include 320 subjects. Based on prior discussions with the FDA and the UK Medicines and Healthcare Products Regulatory Agency, or MHRA, the study is intended to support potential future submissions of marketing applications for a new undisclosed indication in both the U.S. and Europe. RedHill estimates that, if the Phase III clinical study is successful and the marketing applications are filed and approved by the FDA and the MHRA, the new indication would significantly expand the potential market for RHB-102. In parallel to pursuing the new undisclosed indication, RedHill is pursuing marketing approval of RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting in Europe and the U.S.
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August 27, 2015
07:19 EDTRDHLRedHill receives notice of allowance for Israeli patent for Crohn's treatment
RedHill Biopharma announced that it has received a Notice of Allowance from the Israeli Patent Office for a new Israeli patent No. 207420 covering the formulation of RHB-104, a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. Once granted, the patent is expected to be valid through at least 2029. The new patent allowance in Israel further extends the geographic reach of RedHill's intellectual property for RHB-104 and is an addition to already granted U.S. patents and pending filings in other countries.
August 24, 2015
09:05 EDTRDHLRedHill reports peer-reviewed publication showing potential of ABC294640
RedHill Biopharma announced the publication of an article evaluating the therapeutic potential of ABC294640, the company's orally-administered first-in-class Sphingosine kinase 2, or SK2, selective inhibitor, in the treatment of prostate cancer. The article, authored by scientists from Apogee Biotechnology and from the Kimmel Cancer Center at Thomas Jefferson University, will be published in Molecular Cancer Research and is available online on the journal's website. RedHill acquired the rights to Yeliva in March from U.S.-based Apogee. RedHill has also filed a trademark application with the U.S. Patent and Trademark Office for the new brand name Yeliva for ABC294640. Subject to USPTO and FDA approval, the new brand name for the potential commercial product will beYeliva. The article1, entitled "Downregulation of Critical Oncogenes by the Selective SK2 Inhibitor ABC294640 Hinders Prostate Cancer Progression", describes a pre-clinical study conducted with Yeliva in early stage and advanced prostate cancer models. The findings from the study suggest that oral administration of ABC294640 disrupts multiple oncogenic signaling pathways that are deregulated in prostate cancer, corresponding with significant inhibition of tumor growth, proliferation and cell cycle progression. In particular, the compound inhibited in vitro several very resistant types of prostate cancer. The authors of the article conclude that these pre-clinical findings support the hypotheses that SK2 activity is required for prostate cancer function and that ABC294640 could represent a new pharmacological agent for the treatment of early stage and aggressive prostate cancer. The study was supported by a grant from the Pennsylvania Department of Health, a Prostate Cancer Foundation Young Investigator award, and a Prostate Cancer Foundation Mazzone Challenge award.

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