RedHill Biopharma Announces Research Collaboration with Stanford University for YELIVA(TM)
TEL-AVIV, Israel, 2016-09-12 14:00 CEST (GLOBE NEWSWIRE) --
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced a research collaboration with Stanford University School of Medicine (“Stanford”) for the evaluation of RedHill’s proprietary Phase II-stage drug, YELIVA™ (ABC294640).
The research collaboration is intended to complement RedHill’s planned Phase Ib clinical study to evaluate YELIVA™ as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy.
As part of the collaboration, Stanford will evaluate the effect of YELIVA™ on mucositis reduction and tumor control in a murine model of head and neck cancer. YELIVA™ will be administered in combination with a chemotherapy agent and radiotherapy, similar to the design of RedHill’s planned radioprotectant Phase Ib clinical study with YELIVA™, expected to run in parallel with the Stanford research collaboration. Results from the research collaboration are expected in mid-2017.
The Stanford research collaboration is led by Dr. Quynh-Thu Le, MD, a radiation oncologist, Chair of the Stanford Radiation Oncology Department, Co-Director of the Radiation Biology Program of the Stanford Cancer Institute and the Chair of the Head and Neck Cancer Committee of the NRG Oncology Group, part of the National Cancer Institute (NCI) supported National Clinical Trial Network (NCTN).
YELIVA™ is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anti-cancer and anti-inflammatory activities. By inhibiting the SK2 enzyme, YELIVA™ blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation.
RedHill is pursuing with YELIVA™ multiple clinical programs in oncology, inflammatory and gastrointestinal indications. RedHill is evaluating potential clinical studies for additional oncology and inflammatory indications, as well as potential collaboration opportunities to evaluate YELIVA™ as an add-on therapy.
Results from the Phase I study with YELIVA™ in patients with advanced solid tumors confirmed that the study, conducted at the Medical University of South Carolina (MUSC), successfully met its primary and secondary endpoints, demonstrating that the drug is well- tolerated and can be safely administered to cancer patients at doses that provide circulating drug levels that are predicted to have therapeutic activity.
Among the 16 subjects that were assessable for response by RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors), one subject had a partial response with a progression-free survival of 16.9 months, and six subjects had stable disease with a progression-free survival of between 3.5 and 17.6 months. Of the three patients with cholangiocarcinoma, one had a partial response and the other two had stable disease, one for over a year. YELIVA™ was well-tolerated over a prolonged period at doses inducing the expected pharmacodynamic effects.
A Phase Ib/II study with YELIVA™ for the treatment of refractory or relapsed multiple myeloma has recently been initiated at Duke University Medical Center. The study is supported by a $2 million grant from the National Cancer Institute (NCI) Small Business Innovation Research Program (SBIR) awarded to Apogee Biotechnology Corp. (Apogee), in conjunction with Duke University, with additional support from RedHill.
A Phase II study with YELIVA™ for the treatment of advanced hepatocellular carcinoma is planned to be initiated in the coming weeks. The study will be conducted at MUSC Hollings Cancer Center and additional clinical centers in the U.S. It is supported by a $1.8 million grant from the NCI awarded to MUSC, intended to fund a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers, including the Phase II study with YELIVA™ and will be further supported by additional funding from RedHill.
A Phase I/II clinical study evaluating YELIVA™ in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) was initiated at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans in June 2015 and is expected to resume later this year following administrative hold and pending a protocol amendment aimed at improving overall recruitment. The study is supported by a grant awarded to Apogee from the NCI as well as additional support from RedHill.
The studies with YELIVA™ (ABC294640) are registered on www.ClinicalTrials.gov, 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 YELIVA™ (ABC294640):
YELIVA™ (ABC294640) is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anti-cancer and anti-inflammatory activities. RedHill is pursuing with YELIVA™ multiple clinical programs in oncology, inflammatory and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA™ blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA™ was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI and radioprotection models, as well as the ABC-101 Phase I clinical study in cancer patients with advanced solid tumors. The development of YELIVA™ 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. National Cancer Institute, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense and the FDA Office of Orphan Products Development.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill’s current pipeline of proprietary products includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study and an ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA®(RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA™ (ABC294640) - a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered uPA inhibitor, targeting gastrointestinal and other solid tumors; (vii) RP101 - currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class, orally-administered Hsp27 inhibitor, targeting pancreatic and other gastrointestinal cancers; (viii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015; and (ix) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to establish and maintain corporate collaborations; (vi) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (vii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company's business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 25, 2016. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
Senior VP Business Development & Licensing
IR contact (U.S.):
Senior Vice President
The Trout Group
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Abeona Therapeutics Reports Fourth Quarter 2017 Financial Results and Business Highlights16.3.2018 22:32 | Pressemelding
Investor Conference Call on Tuesday, March 27th at 10:00 am ET NEW YORK and CLEVELAND, March 16, 2018 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, today announced financial results for the fourth quarter. The Company will host a call to update investors on recent clinical developments and year-end financial results on Tuesday, March 27th at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-407-9210 (toll free domestic) or 201-689-8049 (International). "The past year was marked by several defining events in the company's history, having advanced our two lead clinical programs, EB-101 in Epidermolysis Bullosa and ABO-102 in MPS IIIA, and initiated our third clinical program, ABO-101 in MPS IIIB. The strong safety and biopotency data observed in our three active clinical trials and the s
Mandela Golden Hands Collection Sells for US$10 Million at PDAC 2018 Conference16.3.2018 15:40 | Pressemelding
Arbitrade, a new coin and cryptocurrency exchange, to purchase the unique gold collection with Bitcoin NEW YORK, March 16, 2018 (GLOBE NEWSWIRE) -- The Board of Arbitrade, a new coin and cryptocurrency exchange, has announced it will purchase the Nelson Mandela Golden Hands Collection. Made from 20 lbs, 99.999 of pure gold, it includes 3 life size impressions of Mandela's hands and two others of his palm and fist. It was cast in 2002 by South Africa's Harmony Gold mining group, one of the world's leading gold producers, 12 years after Nelson Mandela was released from prison. The seller, Malcolm Duncan, a South African businessman now living in Calgary, Canada, knew Mandela. He said that Harmony's intention was to make one full set of gold artefacts consisting of a fist, a full hand and a palm impression of his right hand for each of the 27 years Mandela had spent behind bars. Duncan had purchased the sets dedicated to 1964 and 1990, marking the year Mandela was incarcerated and the yea
RSK Chooses Decentral's Jaxx Blockchain Platform, Paving Way For Smart Contracts On Bitcoin16.3.2018 14:44 | Pressemelding
BUENOS AIRES, Argentina, March 16, 2018 (GLOBE NEWSWIRE) -- RSK, the smart contract platform powered by the Bitcoin network, today announced it has launched on Decentral's Jaxx cryptocurrency wallet and multi-token digital platform. This integration paves the way for RSK's open source platform to implement Ethereum-style smart contracts over the Bitcoin network. RSK combines the flexibility of smart contracts with the Bitcoin infrastructure, bringing endless possibilities to build a more flexible and inclusive financial system that will improve the life of billions of people. RSK successfully released its MainNet network, built as a side-chain to the Bitcoin mainnet, in January 2018. It is now presenting the first wallet that will help dApp developers manage their fuel while creating their solutions powered by RSK and the Bitcoin Network. RSK's CEO, Diego Gutierrez Zaldivar said: "We're very happy to partner with Jaxx, a highly-secure and a very easy-to-use wallet that will be the firs
Up to $200 Billion in Illegal Cybercrime Profits Is Laundered Each Year, Comprehensive Research Study Reveals16.3.2018 13:00 | Pressemelding
Cybercriminals turning to virtual currencies, video game currency and digital payment systems like PayPal to convert illegal revenue into clean cash CUPERTINO, Calif., March 16, 2018 (GLOBE NEWSWIRE) -- Bromium®, Inc., the pioneer and leader in application isolation using virtualization-based security, today announced the findings of an independent, academic study into the macro economics of cybercrime and how cybercriminals launder and 'cash out' the profits of criminal endeavours. The findings are part of a larger nine-month study titled Into the Web of Profit, sponsored by Bromium. The full findings will be presented at the RSA Conference in April by Dr. Mike McGuire, Senior Lecturer in Criminology at Surrey University, England. According to the report, cybercriminal proceeds make up an estimated 8-10 percent of total illegal profits laundered globally; amounting to an estimated $80-$200 billion each year 1. Other key findings include: Virtual currencies have become the primary tool
Technology empowering an increasingly connected SEA for financially inclusive communities16.3.2018 11:41 | Pressemelding
Global speakers IFC, MAS shared their views at Ant Financial Technology Exploration Conference in Singapore SINGAPORE, March 16, 2018 (GLOBE NEWSWIRE) -- Ant Financial Services Group ("Ant Financial" or "Ant") today wrapped up its participation at Money20/20 Asia in Singapore with the Ant Technology Exploration Conference (ATEC), with guests Giri Jadeja, Global Head of Financial Innovation at International Finance Corporation (IFC) and Sopnendu Mohanty, Chief Fintech Officer at Monetary Authority of Singapore (MAS) sharing their views on financial inclusion alongside Cheng Li, Chief Technology Officer and Chief Operations Officer for global business group at Ant Financial. Giri Jadeja shared his vision as global head of financial innovation at IFC - to reach out to the 2 billion unbanked and underserved population in the world, the majority of whom reside in Asia. The region has in recent years seen an exponential growth of new fintech companies. Giri is optimistic that technological c
Z-Wave Alliance Dominates Building Automation Space at Light + Building 201816.3.2018 11:00 | Pressemelding
Exhibitors introduce new products and demonstrate interoperability and collaboration in international Z-Wave smart building and IoT ecosystem FRANKFURT, Germany, March 16, 2018 (GLOBE NEWSWIRE) -- Light + Building 2018 - Hall 9.1, Booth E46 - The Z-Wave Alliance, a global membership organization dedicated to advancing the popular Z-Wave wireless smart home protocol, will host the Z-Wave Pavilion at Light + Building from March 18 - 23, 2018. The Alliance is also demonstrating their award-winning installation toolkit to make installation and testing of a Z-Wave smart home mesh network even easier for the pro installer community. The Z-Wave Pavilion will be on display at the show featuring the latest in European home and building automation and connected lighting products. Z-Wave Alliance members will demonstrate smart home lighting, thermostats, switches, air quality monitors and more. Support for the Z-Wave protocol has never been stronger - the Z-Wave Alliance now boasts over 700-membe
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom