RedHill Biopharma (RDHL) Commences YELIVA Phase 1b/2 in r/r/ Multiple Myeloma

September 8, 2016 8:07 AM EDT

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RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that a Phase Ib/II clinical study evaluating YELIVA (ABC294640) in patients with refractory or relapsed multiple myeloma has been initiated.

The open-label, dose escalation Phase Ib/II study is being conducted at Duke University Medical Center and will enroll up to 77 patients with refractory or relapsed multiple myeloma who have previously been treated with proteasome inhibitors and immunomodulatory drugs.

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

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

“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,” 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™. 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™’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™ in this group of patients. The Phase Ib will be conducted at Duke University Division of Hematologic Malignancies and Cellular Therapy.

The primary objectives of the second portion of the study (Phase II) are to assess the overall treatment response rate and overall survival. Secondary objectives include evaluating the treatment response to YELIVA™ in patients with refractory or relapsed multiple myeloma after three cycles of treatment and evaluation of pharmacodynamic markers. The Phase II portion will be conducted at multiple sites and will be managed by the Duke Cancer Network.

Results from the Phase I study with YELIVA™ in patients with advanced solid tumors confirmed that the study, conducted at the Medical University of South Carolina (MUSC), 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.

Among the 16 subjects that were assessable for response by RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors), one subject had a partial response with a progression-free survival of 16.9 months, and six subjects had stable disease with a progression-free survival of between 3.5 and 17.6 months. Of the three patients with cholangiocarcinoma, one had a partial response and the other two had stable disease, one for over a year. YELIVA™ was well tolerated over a prolonged period at doses inducing the expected pharmacodynamic effects.

A Phase II study with YELIVA™ for the treatment of advanced hepatocellular carcinoma is planned to be initiated in the coming weeks. The study will be conducted at MUSC Hollings Cancer Center and additional clinical centers in the U.S. It is supported by a $1.8 million grant from the NCI awarded to MUSC, intended to fund a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers, including the Phase II study with YELIVA™, and will be further supported by additional funding from RedHill.

A clinical study to evaluate YELIVA™ as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy is also planned.

A Phase I/II clinical study evaluating YELIVA™ in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) was initiated at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans in June 2015 and is expected to resume later this year following administrative hold and pending a protocol amendment aimed at improving overall recruitment. The study is supported by a grant awarded to Apogee from the NCI, as well as additional support from RedHill.

The studies with YELIVA™ (ABC294640) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.



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