Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce preliminary results from Part 1 of the Phase 1/2 clinical trial of its DNA ImmunoBody® vaccine in patients with Stage III/IV malignant melanoma. Of the six patients allocated to the 2mg and 4mg dose cohorts and who received at least four doses of SCIB1, four have shown a vaccine-induced T cell response to treatment.
Although the study was not designed primarily to measure tumour response, one patient in the 4mg dose cohort with multiple tumour lesions at study entry had a differential response to treatment including partial or complete regression of all lung metastases. A further two patients who had all their tumours surgically removed prior to SCIB1 treatment have remained disease-free more than a year after first dosing. The vaccine produced very few side effects, none of which were serious.
These encouraging results provide the first evidence that Scancell's ImmunoBody® vaccine approach is producing an immune response in cancer patients which may also be associated with clinical benefit. In view of the positive results and minimal side effects seen with the 4mg dose the Company intends to evaluate an 8mg dose in parallel with Part 2 of the Phase1/2 study.
Prof Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: "These preliminary results show for the first time that Scancell's ImmunoBody® vaccine, SCIB1, can elicit melanoma-specific immune responses in patients that appear to be associated with clinical benefit and provides clinical validation for the ImmunoBody® approach. The assessment of a higher dose in patients with evaluable disease and the further assessment of immune responses in Part 2 of the Phase 1/2 trial should provide further evidence to support the use of ImmunoBody® vaccines for the treatment of cancer".
Prof Poulam Patel, Principle Investigator and Prof of Clinical Oncology at the University of Nottingham, commented: " I am pleased that we have successfully completed the first part of this study and that we have seen measurable immune responses in patients. I am particularly interested in the shrinkage of the tumours we have seen in a patient with lung secondaries and look forward to seeing the results of the next part of the study,"
Leading oncologist Karol Sikora, Professor of Cancer Medicine and external assessor to Scancell commented: "The positive immune response data and impressive clinical response in the patient with multiple lung metastases is encouraging news for patients with malignant melanoma. The temporal relationship of the disappearance of the lung metastases in this patient is very suggestive of the effective immune destruction of the cancer. I look forward to seeing the results of the ongoing studies and in particular whether a higher dose of SCIB1 will confirm the impact of SCIB1 on active disease."