On August 24, 2015 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 (GI) diseases, including gastrointestinal cancers, reported the publication of an article evaluating the therapeutic potential of ABC294640, the Company’s orally-administered first-in-class Sphingosine kinase 2 (SK2) selective inhibitor, in the treatment of prostate cancer (Press release, RedHill Biopharma, AUG 24, 2015, View Source [SID:1234507329]). The article, authored by scientists from Apogee Biotechnology Corporation ("Apogee") 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 (ABC294640) in March 2015 from U.S.-based Apogee.

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RedHill has also filed a trademark application with the U.S. Patent and Trademark Office (USPTO) for the new brand name YELIVA for ABC294640. Subject to USPTO and FDA approval, the new brand name for the potential commercial product will be YELIVA.

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 (ABC294640) in early stage and advanced prostate cancer models. The findings from the study suggest that oral administration of ABC294640 (YELIVA) 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 (YELIVA) 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.

Charles Smith, Ph.D., President and CEO of Apogee Biotechnology Corporation and one of the authors of the article, said: "This paper provides further definition of the mechanism of the anticancer activities of ABC294640, including the first demonstration of inhibition of signaling through the androgen receptor pathway, which is critical for prostate cancer growth. The growing body of mechanistic and clinical data on ABC294640 suggests that this drug may be useful for the treatment of early-stage and castrate-resistant prostate cancer."

Patricia Bandeira, RedHill’s Product Manager for YELIVA (ABC294640), added: "We are pleased to have these important findings, suggesting that ABC294640 could be effective in treating prostate cancer, published in a peer-reviewed journal. ABC294640, under its new brand name YELIVA, is a novel and promising drug candidate with multiple potential oncology and inflammatory indications. RedHill recently initiated a Phase I/II study of YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma, and is progressing towards a second Phase II study to evaluate YELIVA (ABC294640) as a radioprotectant in cancer patients undergoing therapeutic radiotherapy, and a third Phase II clinical study for the treatment of multiple myeloma."

YELIVA (ABC294640) is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple inflammatory, gastrointestinal (GI) and oncology indications. SK2 is an innovative molecular target for anti-cancer therapy because of its critical role in catalyzing the formation of the lipid-signaling molecule sphingosine 1-phosphate (S1P), which is known to regulate cell proliferation and activation of inflammatory pathways. By inhibiting SK2, YELIVA (ABC294640) could potentially be effective in treating multiple inflammatory, gastrointestinal and oncology indications.

RedHill recently initiated a Phase I/II clinical study in the U.S. evaluating YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL). The Phase I/II study is intended to evaluate the safety and tolerability of YELIVA (ABC294640), as well as provide a preliminary evaluation of efficacy of the drug in patients with refractory/relapsed DLBCL, primarily patients with HIV-related DLBCL. Up to 33 patients are expected to be enrolled in the study, which will be conducted at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans. The study is supported by a grant from the National Cancer Institute (NCI) Small Business Technology Transfer (STTR) program.

A second Phase II study is planned to evaluate YELIVA (ABC294640) as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy. RedHill also plans a third Phase II clinical study for the treatment of multiple myeloma, subject to a pending grant from the National Cancer Institute.

Numerous successful pre-clinical studies were conducted with YELIVA (ABC294640) in GI, inflammation, radioprotection and oncology models, as well as a successful Phase I clinical study in cancer patients with advanced solid tumors. The open-label, dose-escalation, Phase I clinical study demonstrated the drug’s safety and assessed its pharmacokinetics and pharmacodynamics in cancer patients with advanced solid tumors.

About YELIVA (ABC294640):

YELIVA (ABC294640) is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anti-cancer and anti-inflammatory activities, targeting multiple potential inflammatory, oncology and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA (ABC294640) blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid that promotes cancer growth and pathological inflammation. YELIVA (ABC294640) was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in inflammatory, GI, radioprotection and oncology models, as well as a Phase I clinical study in cancer patients with advanced solid tumors. A Phase I/II clinical study evaluating YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) has been initiated in the U.S. The development of YELIVA (ABC294640) was funded to date primarily through grants and contracts from U.S. Federal and State government agencies.