RE: Moditope12 Oct 2022 07:31
I realise that given the amount of time the trials have been going and the upcoming result and AGM we are all eagerly anticipating news. Perhaps we can draw parallels with the SCIB1 trial that commenced in June 2010.
Here is the AGM statement issued just six months later:
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Tue, 14th Dec 2010 07:00
14 December 2010 Scancell Holdings Plc ('Scancell' or the 'Company') AGM Statement
At the Annual General Meeting of Scancell Holdings Plc, (AIM: SCLP), to be held later today, David Evans, Chairman will give shareholders an update and review of the business. This will include the following statement:
This has been an exciting and busy year for Scancell in which the Company has successfully achieved all of its commercial and scientific aims in line with its strategy. Of particular note is the successful progression of Scancell's first vaccine, SCIB1 for melanoma, which entered clinical trials in June 2010. The Company also successfully raised £2.5 million in April 2010 and moved from PLUS to AIM in July 2010.
SCIB1 Phase I Clinical Trial
Clearly, a move into clinical trials for SCIB1 represents an important milestone. This followed Clinical Trial Approval from the Gene Therapy Advisory Committee and by the Medicines and Healthcare Products Regulatory Agency Medicines Division. The approvals enabled Scancell to commence its Phase I clinical trial of SCIB1 in June 2010, to evaluate the safety and tolerability of SCIB1 in patients with late stage melanoma. To date, four patients have been enrolled on the trial which is currently taking place at three centres. Recruitment has been slower than anticipated due to the fact that a number of patients with advanced melanoma - the patients we require - are either being recruited into B-raf* studies or offered ipilimumab** on a compassionate use basis. By the time the patients have failed to respond to either (or both) of these treatments, they are often too ill to enter our study. Overall this has had an impact on the recruitment rates for the Phase I study, however the Company still expects to complete the clinical trial by the end of 2012.
To accelerate the advancement of the trial, two further centres will be opened, and Scancell has also filed protocol amendments to recruit patients with less severe disease. These earlier stage patients should make better immune responses which should ultimately have a positive effect on the outcome on our trial. The issue of patient recruitment is not expected to apply to the Phase II trial which will be conducted in less severely ill patients. The delay to patient recruitment may also have resource implications. Without Phase I clinical results (due in late 2011), it may be difficult to generate revenues from a commercial deal on the ImmunoBody® technology and it may therefore be necessary to augment the Company's capital resources to complete the Phase II study.
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