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September 8, 2016

RedHill Biopharma begins Phase Ib/II clinical study of YELIVA to treat multiple myeloma

Israeli-based RedHill Biopharma has commenced its Phase Ib/II clinical study of YELIVA (ABC294640) to treat refractory or relapsed multiple myeloma.

Israeli-based RedHill Biopharma has commenced its Phase Ib/II clinical study of YELIVA (ABC294640) to treat refractory or relapsed multiple myeloma.

YELIVA is a patented, orally administered, sphingosine kinase-2 (SK2) selective inhibitor characterised with anti-cancer and anti-inflammatory aspects.

The inhibition of the SK2 enzyme results in the prevention of the synthesis of sphingosine 1-phosphate (S1P), a lipid signalling molecule triggering cancer growth and pathological inflammation.

The open-label, dose escalation Phase Ib/II trial is planning to enrol 77 patients with refractory or relapsed multiple myeloma previously treated with proteasome inhibitors and immunomodulatory drugs.

"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 in this serious, chronic disease."

The trial is being conducted at Duke University Medical Centre, with the associate professor in the division of hematologic malignancies and cellular therapy in the department of medicine at Duke University School of Medicine, Dr Yubin Kang serving as the lead investigator.

The Phase Ib portion of the trial is primarily focused on determining the safety and the maximum tolerated dose (MTD) of YELIVA, while its secondary objectives entail the determination of the pharmacokinetic (PK) and pharmacodynamic (PD) properties of YELIVA.

The Phase II portion is aimed at examining the overall treatment response rate and survival results from YELIVA, and its secondary objectives are to test the treatment response to YELIVA and its pharmacodynamic markers after three cycles of treatment.

RedHill medical director Terry Plasse said: "We are very pleased that this study with YELIVA 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 in this serious, chronic disease.

“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.”

The company is planning to initiate a Phase II study of Yeliva to treat advanced hepatocellular carcinoma, which will be conducted at MUSC Hollings Cancer Centre and additional clinical centres in the US.

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