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.
Agreements and Collaborations
Scancell secured two key agreements during the year: a worldwide non-exclusive
licensing agreement with the National Institutes of Health, an agency of the
United States Department of Health and Human Services, for use of two melanoma
antigens as key components of SCIB1; and, a licensing agreement with Cancer
Research Technology Ltd, Cancer Research UK's commercialisation and development
arm to use a human antibody for the development of new ImmunoBody® vaccines for
any immunotherapy indication.
The Company also entered two important strategic collaborations: with
ImmuneRegen BioSciences, Inc.®, a wholly owned subsidiary of IR BioSciences
Holdings, Inc. (OTC BB:IRBS.OB) to investigate the synergy between
ImmuneRegen's Homspera® and Scancell's ImmunoBody® vaccine technologies; and
with immatics biotechnologies GmbH to explore the development of novel
ImmunoBody® vaccines for colorectal cancer.
The Directors are pleased with Scancell's progress during 2010 and look forward
to updating shareholders on the future advancements in due course.
For further information contact:
Scancell Holdings Plc + 44 (0)20 7245 1100
Professor Lindy Durrant
Hansard Communications + 44 (0)20 7245 1100
Kirsty Corcoran
Zeus Capital - Nominated Adviser/Joint Broker + 44 (0)161 831 1512
Ross Andrews/Tom Rowley
Matrix Corporate Capital LLP - Joint Broker + 44 (0)20 3206 7340
Robert Naylor/Stephen Waterman
Notes to Editors
During the past year, data has emerged from studies of two new treatments in
Stage IV patients.
* Firstly, a study of a B-raf inhibitor in patients with advanced melanoma
demonstrated tumour regression in 80% of patients (although this did not result
in a long-term survival advantage).
** Secondly, a Phase III trial of the anti-CTLA4 monoclonal antibody ipilimumab
has demonstrated prolonged survival of Stage IV melanoma patients, with 23.5%
still alive after two years. This is the first drug to have a positive impact
on survival and is likely to receive approval for use in patients with advanced
metastatic melanoma next year. Even if this drug is approved, this still leaves
75% of patients with no appropriate therapy and in potential need of our
vaccine.
About Scancell
Scancell is developing novel therapeutic vaccines for the treatment of cancer
and infectious diseases based on its groundbreaking ImmunoBody® technology
platform. Scancell's first cancer vaccine SCIB1 is being developed for the
treatment of melanoma and has recently entered clinical trials.
Treating cancer by vaccination allows small non-toxic doses of a vaccine to be
administered to a patient, stimulating an immune response. Effective cancer
vaccines need to target dendritic cells to stimulate both parts of the cellular
immune system; the helper cell system where inflammation is stimulated at the
tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system
cells are primed to recognise and kill specific cells.
A limitation of many cancer vaccines currently in development is that they
cannot specifically target dendritic cells in vivo. Several groups have
demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing
them with tumour antigens and re-infusing them. However, this procedure is
patient specific, time consuming and expensive. Scancell has developed its
breakthrough patent protected ImmunoBody® technology to overcome these
limitations.
An ImmunoBody® is a human antibody or fusion protein engineered to express
helper cell and CTL epitopes from tumour antigens over-expressed by cancer
cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour
antigens as they have long half-lives and can effectively target dendritic
cells via their Fc receptors, allowing efficient stimulation of both helper and
CTL responses.
The Immunobody® technology can be adapted to provide the basis for treating any
tumour type and may also be of potential utility in the development of vaccines
against hepatitis, HIV and other chronic infectious diseases.
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