Sophiris halts cancer study after patient death
pharmafile | June 25, 2018 | News story | Research and Development, Sales and Marketing | Cancer, Sophiris, pharma, prostate cancer
Another clinical trial has been forced to a standstill as biotech firm Sophiris revealed that a patient death had prompted it to put the brakes on its Phase 2b investigation into the efficacy of its pore-forming protein topsalysin in the treatment of prostate cancer.
The death was said to occur on the same day as the patient’s second administration of the therapy, and Sophiris, upon hearing the unfortunate news, halted the administration of any further second doses. Details of what caused the death were not revealed.
According to the company, over 450 have been given a single administration of topsalysin in a variety of dosages, and it has remained well-tolerated throughout testing.
“We are extremely saddened by the death of a patient after receiving a second administration of topsalysin,” said Randall E Woods, President and CEO of Sophiris. “Understanding the cause of the patient’s death is our first priority and essential to determining the potential for re-administration of topsalysin in future clinical trials.”
Sophiris said that the therapy showed efficacy despite the tragic death; 10 of the 35 trial participants demonstrating a clinical response to the drug, of which six achieved a complete oblation with no cancer detected via biopsy after six months.
“We are very encouraged by the safety and biopsy results from a single administration of topsalysin in the Phase 2b study,” Woods continued. “Biopsy results improved from what we saw in the Phase 2a proof of concept trial and safety and tolerability remains in-line with what we have seen historically. We believe that the safety and biopsy data from the first administration of topsalysin supports moving forward into potential registration studies. We will continue to evaluate whether future clinical development will include an option to administer a second dose as we receive more information about the patient death and additional information from the 10 patients who received a second dose. We will be able to evaluate this towards the end of this year.”
Matt Fellows
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