Antengene is set to commence a Phase II clinical trial of its drug, selinexor, for the treatment of myelofibrosis (MF) patients in China.
China’s National Medical Products Administration granted approval to conduct the trial in the country.
Marketed as Xpovio, selinexor is an oral selective inhibitor of nuclear export (SINE) compound. It was discovered and developed by Karyopharm Therapeutics.
Antengene is currently developing the drug under an exclusive development and commercial rights agreement in several Asia-Pacific markets, including Greater China, Korea, Australia, New Zealand and the ASEAN countries.
The new randomised, open-label, global multi-centre Phase II trial will be carried out at 15 sites in China and enrol a total of nearly 20 subjects.
It will assess the safety and efficacy of selinexor against physician’s choice (PC) in MF patients who have had a minimum of six months of therapy with a Janus kinase 1/2 (JAK) inhibitor.
The trial subjects will be randomised in a 1:1 ratio to receive either selinexor monotherapy or PC therapy.
The proportion of subjects with a ≥35% spleen volume reduction from baseline (SVR35), as analysed by the independent radiographic review committee (IRC) will be the trial’s primary goal.
Antengene founder, chairman and CEO Dr Jay Mei said: “The NMPA’s approval for this clinical trial of selinexor in patients with MF marks another major milestone in our effort in developing selinexor in a broad range of diseases, and a big step towards expanding potential indications for this candidate drug.
“We are confident that selinexor will demonstrate its clinical utility in the treatment of MF as we progress with this clinical development programme.”
Last month, the company announced plans to assess selinexor in the Phase II trial for the MF treatment in China.
MF is a clonal bone marrow neoplasm mainly characterised by fibrosis in the bone marrow, extramedullary hematopoiesis and anaemia among other symptoms.
The disease could potentially progress to leukaemia, which can reduce the survival of the patients.
Antengene is currently performing several trials of selinexor to treat multiple myeloma, diffuse large B-cell lymphoma, endometrial cancer and peripheral T and NK/T-cell lymphoma, with five of them being Phase II/III trials.