Scancell, the Nottingham based cancer vaccine developer, announced that positive progress has been made in the Phase I clinical trial for its experimental melanoma treatment, SCIB1. After a review of safety data for the first three patients receiving the lowest SCIB1 dose, the Cohort Review Committee has approved the escalation to the next dose level and the recruitment of the next cohort of patients.
Scancell also announced that it has obtained approval from the GTAC and MHRA to extend the Phase I SCIB1 trial after initial difficulties in patient recruitment. The SCIB1 trial, which started in June 2010, had been delayed because a portion of the patients required were being recruited into other cancer studies. Scancell applied to GTAC and MHRC to extend the scope of the trial in December.
Approval has now been granted for Scancell to open a fourth testing site in Leeds. In addition, it has also gained approval to recruit patients that are slightly less sick than allowed in the original clinical protocol. Now, Scancell can recruit any patient with Stage III (when the cancer has begun to spread to local lymph nodes) or Stage IV (when the cancer has spread to more distant parts of the body) malignant melanoma. Originally only inoperable (not suitable for surgery) Stage III and Stage IV patients were eligible.
The expansion in trial sites and patient eligibility criteria should speed up the Phase I trial. The company noted in its December AGM announcement that the Phase I trial delay may cause the need to raise £500,000 to £1 million in the latter part of 2011.
Scancell noted that it made an operating loss of £835,540 for the half year to October 31st 2010 (2009: £661,794) and a net loss of £802,170 (2009: £626,126). Cash at bank was £1.7 million (2009: £1.1 million).
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