DGAP-News

RedHill Biopharma Ltd.: RedHill Biopharma Announces Phase Ib/II Study with YELIVA(TM) Initiated for Multiple Myeloma at a Leading U.S. Academic Medical Center - Seite 2

Dr. Yubin Kang, MD, Associate Professor in the Division of Hematologic
Malignancies and Cellular Therapy in the Department of Medicine at Duke
University School of Medicine, is the lead investigator for the study.

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.

YELIVA(TM) 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(TM) blocks
the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule
that promotes cancer growth and pathological inflammation.

RedHill is pursuing with YELIVA(TM) multiple clinical programs in oncology,
inflammatory and gastrointestinal indications.

"We are very pleased that this study with YELIVA(TM) has been initiated at
Duke University. Award of the NCI funding to support the study and the
interest in the product by a major research university confirms the
potential promise of YELIVA(TM) in this serious, chronic disease," said
Terry Plasse, MD, RedHill's Medical Director. "The clinical study follows a
successful preclinical study demonstrating that sphingosine kinase-2 is
overexpressed in multiple myeloma cell lines and in human specimens, and
that its inhibition may fight the disease. This is the second Phase I/II
study initiated with YELIVA(TM). We expect to initiate additional clinical
studies in the coming months, including studies in advanced hepatocellular
carcinoma and prevention of mucositis in head and neck cancer patients
undergoing therapeutic radiotherapy. Given YELIVA(TM)'s unique mechanism of
action, we continue to evaluate its therapeutic potential for multiple
oncology, inflammatory and gastrointestinal indications, as a single agent
and in combination with other oncology drugs."

The primary objectives of the first portion of the study (Phase Ib) are to
assess safety and determine the maximum tolerated dose (MTD) in refractory
or relapsed multiple myeloma patients. Secondary objectives include
assessment of antitumor activity and determination of the pharmacokinetic
(PK) and pharmacodynamic (PD) properties of YELIVA(TM) in this group of
patients. The Phase Ib will be conducted at Duke University Division of
Hematologic Malignancies and Cellular Therapy.