June 17, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NOTTINGHAM, England – British drugmaker Scancell Pharma suspended its Phase I/II clinical trial investigating the experimental immunotherapy SCIB1 after determining that a stored batch of the drug failed a quality control analysis.
The company said the stored drug product was “no longer within the original specification” and opted to suspend the eight-patient trial to ensure patient safety. SCIB1 as a monotherapy being developed for the treatment of melanoma.
The SCIB1 trial originally began in 2010 with an original estimated time of about six months. However, the company said the data from those early studies have been promising enough to add additional amendments to the trial protocol to examine long-term dosing regimens. The 2010 start date for the trial was the explanation for the investigational drug to have passed its expiration date. “Patient safety has always been our primary responsibility. 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,” Richard Goodfellow, chief executive officer of Scancell said in a statement. “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 6 years.”Scancell said it is planning to make a fresh batch of SCIB1, but anticipates a delay of up to one year before the new material will be available for use in trial. However, Scancell said interim data from the trial has been encouraging and “clearly warrants further investigation” into the treatment of melanoma. Although patients will have to wait for a new batch of SCIB1, Scancell said it anticipates the anti-tumor response seen in patients “should persist and eliminate any remaining tumor cells.”
“Further doses of SCIB1 have been given for added protection to ensure the immune cells continue to patrol for any emerging cancer cells; subsequent administration of the new SCIB1 material should reactivate these memory immune cells to eliminate any recurring tumors,” the company said in a statement this morning.
In addition to beginning a new batch of the experimental drug, Scancell said it signed an agreement with a new manufacturer. The primary reason for the new manufacturer is to support a new study of SCIB1 in combination with a checkpoint inhibitor, the company said in a statement.
of Scancell, which is sold on the London Stock Exchange, are down more than 16 percent in trading this morning, hitting a low of £13. The stock closed Thursday at £18.50 per share.
