Scancell Holdings PLC. (SCNLF)

[Gift_Horse]

Part 1 Dosing Completed In Additional Tumor Trial

I reported last August on Scancell's decision to seek an extension to their Phase I/II trial of their SCIB1 DNA dendritic cell vaccine to treat metastatic melanoma. Part 2 of the original trial was completed last year with the vaccine being given to patients whose tumors had been surgically removed with the intention of generating a strong enough immune response with SCIB1 to prevent recurrence. Results of this originally intended final Part exceeded the directors highest expectations.

But as a result of a finding in the original Part 1, which was a dose escalation study beginning in June 2010 and reporting in December 2012, a decision was made to seek initially an extension to Part 1 and then to Part 2. To the surprise of the researchers the vaccine had the effect of completely eliminating all metastatic tumors in one patient's lungs. This was a patient in one of the higher dose, 4mg, cohorts whose tumors were inoperable.

It is well known that dendritic cell vaccines (the only type of cancer vaccine authorized for use by the FDA) do not as a rule shrink tumors, let alone eliminate them. So following permissions from the United Kingdom's Gene Therapy Advisory Committee ('GTAC') and the Medicines and Healthcare products Regulatory Agency ('MHRA') five patients with metastatic tumors were given SCIB1, at a new higher dose of 8mg as an extension to the original Part 1 study looking at dosage safety as well as immune and clinical responses to the vaccine. The final patient of this new cohort with tumor load has now been dosed. There were no reported serious adverse events. Immunological and clinical responses will be assessed and reported at the end of Q2. Obviously investors will be awaiting this data with bated breath.

We also learn today that Part 2 of this new higher 8mg dose in patients with tumor load has now begun with the first patient receiving their first inoculation of SCIB1 earlier this week. Up to thirteen patients with tumor load will be included in this extended second part.

Here is a useful article reporting today's news:
Scancell completes part 1 dosing for cancer study