Scancell Holdings Plc (LON:SCLP) has told investors that its SCIB1 skin cancer treatment continues to produce remarkable survival data from the ongoing phase I/II clinical trial.
Overall, 18 of the 20 stage III/IV melanoma patients with resected disease (i.e. some or all of the tumour has been surgically removed in the past) remain alive and have lived significantly longer than the ‘established norms’.
Of the 16 resected patients who received 2-4 milligram (mg) doses of SCIB1, only six patients have had a recurrence of their disease while only two have died.
The median observation time for this group of patients is edging up towards five years, with seven patients in the trial surviving for longer than that since starting treatment.
Remarkably, four of those have managed to live for that period without having the disease return.
One patient with unresected disease has also been able to survive for longer than five years since starting treatment with SCIB1 despite the disease progressing.
Two of four resected patients who received stronger 8mg doses of SCIB1 have experienced disease recurrence although none have died, Scancell added.
“We are pleased to report that most patients with resected disease enrolled in the SCIB1 clinical trial are still alive and without disease recurrence, including the majority of patients who were previously undergoing continuation treatment,” said chief executive Richard Goodfellow.
READ:Scancell hails "compelling" results from clinical trial
Data compares well with ipilimumab
The data gathered so far compares favourably with ipilimumab which has previously received approval in the US, Canada and the EU.
In total, 46.5% of stage III patients who were given ipilimumab survived for three years without the cancer recurring, compared to just 34.8% of those on the placebo.
By comparison, of the 16 resected, stage III/IV patients treated with SCIB1, recurrence-free survival at three years was 69%. It must be noted that Scancell’s trial is on a much smaller scale so more data will need to be collected before any concrete conclusions can be drawn.
Next study will be in the States
Investors have known for a while that the enxt SCIB1 study will be in the United States, something Scancell reiterated today.
A new batch of the drug has been manufactured and will be released for clinical use later this quarter.
That will coincide with the submission of the investigational new drug (IND) application to the US Food and Drug Administration for a phase II trial, which is on track to be submitted before the end of September.
“Our next study, which will be in the US, will assess the potential for an increase in response rate in patients with malignant melanoma when treated with SCIB1 and a checkpoint inhibitor,” said Goodfellow.
Don’t forget, Richard Goodfellow is presenting at the next Proactive Investors One2One Forum on Thursday (13 July) in London. Click here for more details.