Noxopharm Ltd (ASX:NOX) has been cleared to enrol the next patient cohort for its CEP-2 sarcoma trial assessing the combination of Veyonda® with chemotherapy drug doxorubicin after it cleared a second safety milestone.
The CEP-2 Safety Steering Committee has reviewed the safety data from the second cohort of patients in the trial and found the 1,200 mg dose to be safe and well tolerated.
This means the trial will now be allowed to continue enrolling new patients who will be treated with a higher 1,800 mg dose of Veyonda®.
This patient cohort will be the last for the safety phase of the study and if tolerated satisfactorily, will pave the way for the efficacy phase to begin.
Two new sites
In order to speed up patient enrolment, Noxopharm has added Northwestern University in Illinois and the Medical College of Wisconsin to the list of other prominent names already participating in the trial.
These prestigious hospitals in the US include the City of Hope Cancer Center in Los Angeles, the Mayo Clinics in Minnesota and Florida and Washington University in St Louis.
Highest dose ever trialled
“After recently passing the first safety milestone in August, the CEP-2 trial has passed its second safety milestone and we are now able to escalate to the highest dose of Veyonda ever trialled in cancer patients,” Noxopharm chief executive officer Dr Gisela Mautner said.
“These safety reviews form a crucial part of the regulatory requirements for a new drug and only through positive safety outcomes can we move forward to the next stage.
“We are also pleased to bring on two additional major US clinical centres and will continue to work closely with our partners to advance these trials as quickly as possible.”
Rare cancer group
About 30 patients in the United States with a range of soft tissue sarcomas are being enrolled to be treated with the Veyonda/doxorubicin combination as a first-line treatment.
As soft tissue sarcomas tend to be very aggressive cancers, up to 50% of high-grade sarcoma patients develop metastases and die within 12 months.
They are defined as a rare cancer group, with fewer than 20,000 new cases diagnosed in the US in 2021.