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Redhill: A Phase I/Ii Study With Yeliva

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

(ABC294640) was recently initiated in the U.S. in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) and is supported by a grant from the NCI to Apogee Biotechnology Corporation

A second Phase II study of YELIVA

(ABC294640) for the treatment of refractory or relapsed multiple myeloma is planned to commence by the end of 2015 and is supported by a $2 million NCI grant awarded to Apogee Biotechnology Corporation; A third Phase II study is planned to evaluate YELIVA

(ABC294640) as a radioprotectant in cancer patients undergoing therapeutic radiotherapy

Top-line res ults from the Phase Ib study with YELIVA

(ABC294640) in patients with advanced solid tumors are expected to be announced in the coming weeks

TEL-AVIV, Israel, Oct. 22, 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 that the U.S. National Cancer Institute ("NCI") has awarded Apogee Biotechnology Corporation ("Apogee") a $225,000 Small Business Innovation Research Program ("SBIR") grant to support a pre-clinical study with YELIVA

(ABC294640) for the treatment of prostate cancer. In March 2015, RedHill acquired from Apogee the exclusive worldwide rights to YELIVA

(ABC294640), a proprietary, first-in-class, orally-administered sphingosine kinase-2 ("SK2") selective inhibitor.

Following prior pre-clinical studies in early-stage and advanced prostate cancer models, the NCI grant is intended to support additional studies with YELIVA

(ABC294640) to determine its therapeutic efficacy in

in vitro

in vivo

models of prostate cancer in combination with radiotherapy. These pre-clinical studies could potentially support future clinical studies with YELIVA

(ABC294640) for this important indication with over 200,000 estimated new cases of prostate cancer in the U.S. in 2015

The previous prostate cancer pre-clinical study, 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, is described in an article authored by scientists from Apogee and from the Kimmel Cancer Center at Thomas Jefferson University, and was initially published online in Molecular Cancer Research. The article, entitled

"Downregulation of Critical Oncogenes by the Selective SK2 Inhibitor ABC294640 Hinders Prostate Cancer Progression

, describes the findings of the pre-clinical study, suggesting that oral administration of YELIVA

(ABC294640) disrupts multiple oncogenic signaling pathways that are deregulated in prostate cancer, including significant inhibition of tumor growth, proliferation and cell cycle progression. In particular, the article noted that YELIVA

(ABC294640) inhibited,

in vitro,

several very resistant types of prostate cancer. The authors of the article conclude that their pre-clinical findings support the hypotheses that SK2 activity is required for prostate cancer growth and that YELIVA

(ABC294640) could represent a new pharmacological agent for the treatment of aggressive prostate cancer.

A Phase I/II clinical study was recently initiated in the U.S. evaluating YELIVA

(ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL), primarily in patients with HIV-related DLBCL. The study is being conducted at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans and is supported by a grant awarded to Apogee from the NCI Small Business Technology Transfer (STTR) program.

A Phase II study of YELIVA

(ABC294640) for the treatment of refractory or relapsed multiple myeloma is planned to be initiated by early 2016. The study will be conducted at Duke University Medical Center and has received Institutional Review Board...