Scancell Holdings Plc (LON:SCLP) said it is working as quickly as possible to secure new supplies of its flagship cancer drug SCIB1 after withdrawing the current batch.
The company said that quality control analysis revealed the “stored drug product is no longer within the original specification”.
“In discussion with the MHRA Clinical Trials Unit, and with patient safety of primary importance, the company has concluded that it is no longer suitable for further use, although no new side effects have emerged,” Scancell added.
The suspension affects eight of the 35 patients in the long-term extension arm of the phase 1/2 trial using SCIB1 to treat melanoma. Scancell stressed researchers have seen “no adverse events”.
SCIB1-001 was originally started in 2010 and the plan was simply to administer the drug to patients for six months.
But encouraging results and an excellent side-effect profile led to far longer dosing regimen than was intended and Scancell said some of the trial materials have now been stored for over seven years.
It was planning with the help of a specialist manufacturer to make a fresh batch of SCIB1, which was to be used in combination with a checkpoint inhibitor to treat cancer patients.
However the new material will go first to those people on the extended trial.
Because the drug is thought to stimulate an immune response its anti-tumour effects should “persist” for the time it takes to source new supplies, which could be nine to 12 months.
"Patient safety has always been our primary responsibility,” said Scancell chief executive Dr Richard Goodfellow.
“Although we have seen no new adverse events it is unfortunate, but nevertheless appropriate, that we suspend dosing of SCIB1 at this time while we work as quickly as possible to secure new supplies of this promising potential treatment for melanoma.
“Starting further efficacy studies with SCIB1 is only possible due to the results we have seen so far in the long-running SCIB1-001 study and we would again like to convey our thanks to the patients in that trial for their participation and support over the past six years."