Catalist-listed iX Biopharma has announced that its novel Wafermine sublingual ketamine wafers will be used in a study to evaluate its use as a treatment for pain suffered by patients with advanced cancer.
The pilot study will be funded by Chris O’Brien Lifehouse, a comprehensive cancer hospital in Camperdown, Sydney.
The study is a prospective double-blind randomised placebo-controlled repeated cross-over trial and will be carried out at 2 sites, Chris O’Brien Lifehouse cancer centre and Royal Prince Alfred Hospital. It will enrol 32 adult patients with locally advanced or metastatic cancer who experience moderate to severe pain associated with cancer diagnosis requiring ongoing opioid analgesia. The study objectives include the measurement of pain severity, pain impact, side effects and quality of life.
The study will be led by Dr Yi-Ching Lee, consultant pain specialist in Chris O’Brien Lifehouse and Royal Prince Alfred Hospital. “We have been using sublingual ketamine at Royal Prince Alfred Hospital to treat patients with refractory pain effectively. After reviewing Wafermine’s study data to-date and our own clinical experience with sublingual ketamine, we believe that Wafermine has the potential to be used effectively to treat breakthrough cancer pain,” Lee says.
“The results of this study will assist in the conduct of a definitive trial in guiding physicians on the use of Wafermine to treat cancer pain, which is a condition with significant unmet medical need,” she adds.
According to iX Biopharma’s filing to SGX on June 15, while Ketamine is a clinically established pain management method for cancer patients suffering moderate to acute severe pain, it is currently administered intravenously, which limits the drug’s broader use in addition to potentially causing severe side effects. In comparison, Wafermine, which is administered sublingually, would be easier to administer and with less severe side effects, making it more accessible to patients.
iX Biopharma also highlights that the study unlocks Wafermine’s potential to address the global cancer pain market, estimated at US$5.5 billion ($7.3 billion).
Shares in iX Biopharma closed 0.5 cents or 2.08% higher at 24.5 cents on June 14.
Photo: iX Biopharma
