The Multiple Myeloma Research Consortium (MMRC) and Keryx Biopharmaceuticals has announced the initiation of a multi-centre phase I clinical programme to explore the convenient all-oral combination of KRX-0401 (perifosine), Revlimid (lenalidomide, Celgene Corporation) and dexamethasone for the treatment of relapsed or refractory multiple myeloma.
Under the lead of Andrzej Jakubowiak, MD, PhD, director, Multiple Myeloma Centre of University of Michigan Comprehensive Cancer Centre (Ann Arbor, MI), the study will also be conducted at four other of the MMRC's 13 world-renowned member academic institutions.
Entitled "An Open-Label phase I study of the safety of Perifosine in combination with Lenalidomide and Dexamethasone for patients with relapsed or refractory Multiple Myeloma," the clinical programme represents the first time this oral triplet is being explored in the clinical setting for this incurable blood cancer.
The study is being conducted to determine the safety and efficacy of the drug combination in the treatment of these patients, as well as the highest dose at which KRX-0401 can be safely administered to multiple myeloma patients when combined with Revlimid and dexamethasone.
The clinical programme is being conducted entirely within the MMRC and is one of the first industry-sponsored clinical programmes to open with the organization's assistance. "We are so pleased to be collaborating with Keryx Biopharmaceuticals on this groundbreaking clinical trial and believe that this novel oral combination may represent an important new option for multiple myeloma patients," said Kathy Giusti, founder and chief executive officer of the MMRC, as well as a myeloma patient. "Through this innovative programme and the others we support, our organization continues to facilitate unprecedented collaborations between industry and academia that are expediting meaningful new research and drug development opportunities."
Data from pre-clinical and clinical research studies suggest that KRX-0401 has activity in patients with multiple myeloma. In addition to the clinical trial announced, KRX-0401 is also currently being evaluated in an ongoing multi-centre phase II study as a single agent and in combination with dexamethasone as a treatment for relapsed or relapsed/refractory multiple myeloma and in an ongoing multi-centre phase I/II clinical study in combination with Velcade (bortezomib) for injection for the treatment for multiple myeloma.
Revlimid is currently approved for the treatment of certain types of myelodysplastic syndrome (another form of cancer affecting the blood) and in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
Dexamethasone is a corticosteroid commonly used, either alone, or in combination with other drugs, to treat multiple myeloma.
"Keryx's collaboration with the MMRC will accelerate the development of KRX-0401 as an emerging multiple myeloma therapy," said I. Craig Henderson, MD, president, Keryx Biopharmaceuticals Inc. "We are excited to explore this novel combination of three oral agents, and in addition are appreciative of the MMRC's ongoing commitment to this trial. Hopefully the success of this collaboration will set a precedent that proves valuable to others working in the field."