Redhill forscht mit dem Wirkstoff von Heidelberg Pharma an COVID-19@ Bicypapa, Redhill setzt noch einen drauf und forscht mit dem Wirkstoff von Heidelberg Pharma auch an der Behandlung von COVID-19.
Damit ist Heidelberg Pharma neben ihren anderen spannenden Themen jetzt auch bei Corona mit im Boot. Meldung kam gerade heraus: https://www.redhillbio.com/RedHill/userdata/SendFile.asp?DBI…
RedHill Biopharma Provides Update on Opaganib (Yeliva) Phase 2 study evaluating RedHill’s proprietary NCE1 opaganib (Yeliva, ABC294640) in prostate cancer initiated at Medical University of South Carolina, supported by an NCI grant --- Recruitment initiated in second arm of Phase 1/2a study evaluating opaganib in combination with hydroxychloroquine in advanced cholangiocarcinoma; third arm in planning to evaluate combination of opaganib with RHB-107 (upamostat), a second proprietary NCE ---
RedHill is pursuing an exploratory program of opaganib and RHB-107 individually and in combination with hydroxychloroquine and other compounds for the treatment of COVID-19 (novel coronavirus), based on pre-clinical data and literature indicating potential anti-viral activity TEL-AVIV, Israel and RALEIGH, N.C., March 11, 2020 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company focused on gastrointestinal diseases, today provided an update on its clinical development programs for opaganib (Yeliva, ABC294640)2. An investigator-sponsored Phase 2 study evaluating opaganib in prostate cancer has been initiated at the Medical University of South Carolina (MUSC) Hollings Cancer Center. The study is intended to evaluate the safety and efficacy of opaganib in patients with metastatic castration-resistant prostate cancer (mCRPC) that is progressing during treatment with androgen-signaling blockers abiraterone or enzalutamide. The study is planned to enroll up to 60 patients and is supported by a National Cancer Institute (NCI) grant awarded to MUSC. Professor Michael Lilly, MD, is the Principal Investigator of the study. RedHill has completed the enrollment of the full cohort of 39 patients evaluable for efficacy in the Phase 1/2a study evaluating the activity of orally-administered opaganib in patients suffering from advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma. Preliminary data from the open-label Phase 1/2a study conducted at renowned clinical institutions in the U.S., has indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma. RedHill plans to submit these data for presentation at an upcoming scientific meeting. In light of this, and in light of positive data from a pre-clinical program evaluating opaganib in combination with additional compounds and input from several key opinion leaders, RedHill has added a second arm to the study, evaluating opaganib in combination with hydroxychloroquine, an anti-autophagy agent. Recruitment for the second arm of the Phase 1/2a study has been initiated. RedHill also plans to add a third arm to the study, evaluating opaganib in combination with
RHB-107 (upamostat), a second proprietary new chemical entity (NCE), subject to discussions with the U.S. Food and Drug Administration (FDA). Based on pre-clinical data and literature indicating potential anti-viral activity, RedHill is actively pursuing an exploratory program intended to evaluate the activity of opaganib and RHB-107, individually and in combination with hydroxychloroquine and other compounds in the treatment of COVID-19 (novel coronavirus). About Opaganib (ABC294640, Yeliva) Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, opaganib blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors. Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma. The initial development of opaganib was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. NCI. About RHB-107 RHB-107 (INN: upamostat) is a first-in-class, orally-administered inhibitor of S1 family of trypsin-like serine proteases with potential for use in multiple oncology, gastrointestinal and inflammatory indications. RHB-107 clinical safety profile has been demonstrated in over 300 patients, including in Phase 2 studies in locally advanced pancreatic cancer and metastatic breast cancer. RedHill licensed the worldwide rights to RHB-107 from Heidelberg Pharma AG (formerly Wilex AG), excluding China, Taiwan, Macao, and Hong Kong.
The studies with opaganib for cholangiocarcinoma and prostate cancer are registered on www.clinicaltrials.gov (ClinicalTrials.gov Identifiers NCT03377179 and NCT04207255, respectively), a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on the commercialization and development of proprietary drugs for the treatment of gastrointestinal diseases. RedHill promotes the gastrointestinal drugs Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults3 and Aemcolo for the treatment of travelers’ diarrhea4. RedHill acquired rights to Movantik for opioid-induced constipation5. The acquisition remains subject to certain customary closing conditions and regulatory clearances. RedHill’s key clinical late-stage development programs include: (i)
RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (ii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iii) RHB-102 (Bekinda), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) opaganib (Yeliva), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 1/2a study for cholangiocarcinoma; (v) RHB-106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at www.redhillbio.com.
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