Sona Nanotech Inc (CSE:SONA, OTCQB:SNANF) announced that it has completed its first-in-human clinical study treating patients with histologically confirmed, immunotherapy-resistant cutaneous metastatic melanoma using Sona's Targeted Hyperthermia Therapy (THT).
The company said by day 15, eight of 10 patients experienced a significant clinical response to treatment with a majority (six out of eight) showing no detectable residual melanoma in representative, biopsied tumors, and two patients showing no response.
"These favorable results—demonstrated in the majority of treated patients—show that Sona's THT therapy has successfully eliminated melanoma in tumors where leading treatments had previously failed," Sona Nanotech CEO David Regan said in a statement.
"Based on findings from this study, we are preparing for a Canadian clinical trial that will provide deeper insights into the biological potential of our THT as we prepare to expand its clinical application into a broader range of solid tumor cancers."
Ten advanced-stage patients, all of whom were failing to respond to standard immunotherapy treatment, were recruited into this early feasibility study, according to the company.
Under the study protocol, patients had up to four tumors treated with Sona's THT on days one and eight of the study.
The company added that an application for an investigational testing authorization (ITA) has been made to Health Canada to permit the next clinical study for which Sona Nanotech has already received research ethics board approval.
Another aim of the study, according to the company, was to capture clinician-reported and patient-reported experience with the physical delivery of THT with a view to improving the overall clinical delivery of Sona's therapy.
To this end, Sona noted that “significant’ data was captured highlighting opportunities for design and application enhancement that will be applied and evaluated in future studies.
Shares of Sona Nanotech added 19.1% on Monday to close at C$0.75.
As well, Sona Nanotech announced that its chief scientific officer, Len Pagliaro, is stepping back from an operational role.