The pharmaceutical company Karyopharm Therapeutics is developing a new drug, an oral Selective Inhibitor of Nuclear Export (SINE) compound called Selinexor (KPT-300), which is designed to act against nuclear transport targets for patients with cancer or other major diseases.
The clinical trial associated with the development of the drug is about to begin enter phase 2, and is being led by Dr. Christopher J. Logothetis and Dr. John Araujo of the M.D. Anderson Cancer Center at the University of Texas in Houston.
Researchers will seek to determine the prostate cancer control rate, according to RECIST criteria, and how to prevent new bone lesions, as well as to assess the response of the prostate-specific antigen (PSA) to baseline. This phase of the study of Selinexor in Hormone Refractory Indications in Prostate Cancer (SHIP) includes 50 patients with metastatic hormone-refractory prostate cancer (HRPC), following at least one of the agents, enzalutamide, abiraterone, or radium 223, which were recently approved.
The results from the first phase of the trial were presented at ASCO, revealing an 88% disease control rate, meaning that the therapy results in stable disease or better, in eight evaluable patients with heavily pretreated prostate cancer. “These patients were treated in our Phase 1 clinical trial of Selinexor in advanced or metastatic solid tumors. All had progressive disease upon entering the study and had exhausted available therapies including taxane-based chemotherapy, and many had received newer agents such as enzalutamide and/or abiraterone,” explained Dr. Sharon Shacham, Karyopharm’s Founder, President and CSO.
“We are encouraged by Selinexor’s disease control rate in the prostate cancer patients with significant bone disease in the ongoing phase 1 study, as well as its single-agent activity against a variety of both localized and disseminated prostate cancer in preclinical mouse models. We look forward to assessing the treatment potential of Selinexor in this patient population where there is a high unmet need for further therapy to control their disease and to prolong their lives,” stated Logothetis.
Prostate cancer affects one in every seven men in North America during his lifetime, according to the American Cancer Society. It is the most common cancer in men and the second most common cause of death in North American men. Last April, an easy, non-invasive blood test, the Prostate Health Index (phi), was released nationwide, which is three times more precise in diagnosing prostate cancer than the conventional test for PSA (prostate-specific antigen).
Despite the progress in research, it is still expected that in 2014 in the United States, 29,000 men will die of prostate cancer. “Patients with hormone refractory prostate cancer have very limited options, particularly after their disease progresses on chemotherapy,” explained Logothetis.
The study is being funded in part by a grant from the Prostate Cancer Foundation.