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Actionable news in RDHL: Redhill Biopharma Ltd.,

Redhill: The Phase I Study With Yeliva

The following excerpt is from the company's SEC filing.

(ABC294640) 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

Twenty-one patients with advanced solid tumors were treated with YELIVA

in the study, the majority of which were gastrointestinal cancer patients, including pancreatic, colorectal and cholangiocarcinoma cancers

Administration of YELIVA

resulted in a rapid and pronounced decrease in levels of sphingosine 1-phosphate (S1P) with sever al patients having prolonged stabilization of disease

The U.S. Phase I study was conducted at the Medical University of South Carolina (MUSC) and supported by a grant from the National Cancer Institute (NCI) awarded to MUSC, and a grant from the FDA's Office of Orphan Products Development (OOPD) awarded to Apogee Biotechnology Corp.

is a proprietary, novel, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications, for which several Phase II studies are ongoing and planned, supported by NCI grants awarded to Apogee Biotechnology Corp., as well as directly supported by RedHill

RedHill maintains a strong and debt-free balance sheet with approximately $66 million in cash as of the end of July, supporting the ongoing and planned Phase II clinical studies with YELIVA

TEL-AVIV, Israel, Oct. 26, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced positive top-line results from the Phase I study with YELIVA

(ABC294640) in patients with advanced solid cancers. The study successfully met its primary and secondary endpoints, providing key information about the drug's safety, toxicities, pharmacokinetics (PK) and pharmacodynamics (PD), supporting the ongoing and planned Phase II studies with YELIVA

(ABC294640).

The top-line results from the Phase I study with YELIVA

(ABC294640), demonstrating achievement of primary and secondary endpoints, were provided to RedHill by Apogee Biotechnology Corporation ("Apogee") and remain subject to the completion of an independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the clinical study report (CSR), expected by the end of the year or early 2016. Final results of the study will be presented in the appropriate scientific and medical forums following completion of the CSR.

Charles D. Smith, Ph.D., Apogee's President and CEO, said

: "Sphingosine kinase-2 (SK2) is a new potential target for anticancer therapy because it produces sphingosine 1-phosphate (S1P) which regulates cancer cell proliferation and inflammatory pathways. YELIVA

(ABC294640), a first-in-class, orally-available inhibitor of SK2, is the only agent in its category in clinical trials. The drug has demonstrated anticancer activity in many preclinical models, and the results from this Phase I study in patients with advanced solid tumors indicate that it can be safely administered to cancer patients at doses that provide circulating drug levels that are predicted to have therapeutic activity."

Terry F. Plasse, MD, RedHill's Medical Director, said:

"We are very pleased with the results from this first-in-man study with YELIVA

in advanced solid tumors, which successfully met its primary and secondary objectives. The results demonstrated the safety and tolerability of this novel drug candidate at a pharmacologically active dose, supporting the ongoing and planned Phase II clinical studies with YELIVA

. We continue to aggressively pursue development with this promising drug candidate across multiple cancer and inflammatory indications."

The Phase I study, supported by grants from the U.S. National Cancer Institute ("NCI") awarded to the Medical University of South Carolina ("MUSC") and from the U.S. FDA's Office of Orphan Products Development (OOPD) awarded to Apogee, was conducted at the MUSC Hollings Cancer Center and led by Principal Investigators Melanie Thomas, MD, and Carolyn Britten, MD. The open-label, dose-escalation, pharmacokinetic (PK) and pharmacodynamic (PD) first-in-human Phase I study with YELIVA

(ABC294640) treated 21 patients with advanced solid tumors, the majority of which were gastrointestinal cancer patients, including pancreatic, colorectal and cholangiocarcinoma cancers. The patients were continuously treated in cycles of 28 days with the study drug, in the...


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