2 February 2010
GB00B39J5N63
Scancell Holdings Plc
(`Scancell Holdings' or the `Company')
Clinical Trial Application for SCIB1 melanoma vaccine
Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer
vaccines, is pleased to announce that its proposal to conduct a Phase I
clinical trial on SCIB1, its DNA ImmunoBody® vaccine being developed for the
treatment of melanoma, was submitted to the Gene Therapy Advisory Committee
(`GTAC') on 29 December 2009. In addition, Scancell and its partner Ichor
Medical Systems (`Ichor') submitted parallel applications to the Medicines
Division and to the Devices Division of the Medicines and Healthcare products
Regulatory Agency (`MHRA') on29January 2010 requesting approvals for the
clinical trial of SCIB1 and for the use of Ichor's TriGridâ„¢ electroporation
delivery device to administer SCIB1 to participating patients, respectively.
SCIB1 is a novel DNA ImmunoBody® vaccine being developed using Scancell's
patented ImmunoBody® technology for the treatment of melanoma. ImmunoBody®
vaccines generate the high-avidity T-cells that kill cancer cells, which may
overcome the current limitations of most cancer vaccines. In vivo
electroporation is widely regarded as an effective method of enhancing the
potency of DNA vaccines by up to 100 -fold compared to conventional methods of
delivery. Scancell is confident that TriGridâ„¢ will provide the most effective
delivery system for its SCIB1 melanoma vaccine as it enters clinical trials.
Advanced melanoma currently has a very poor prognosis with late stage (stage
IV) disease having a median survival of approximately six months. According to
the World Health Organisation, 132,000 melanoma skin cancers occur globally
each year and the incidence is increasing, especially in the United States,
Europe and Australia.
David Evans, Chairman of Scancell, commented:
"Scancell's CTA submission and proposal to GTAC to conduct the Phase I clinical
trial for our first therapeutic cancer vaccine marks a significant step for the
Company and we look forward to reporting on its progress. We are confident
that, subject to regulatory and ethical approvals, the Phase I clinical trial
for SCIB1 will be on target to commence in Q2 2010."
A copy of this announcement is available for download on the Company's website
at http://www.scancell.co.uk/
-ENDS-
For further information contact:
Professor Lindy Durrant Scancell Holdings Plc + 44 (0)207 245 1100
John Bick/Kirsty Corcoran Hansard Communications + 44 (0)207 245 1100
+ 44 7872 061 007
Ross Andrews Zeus Capital + 44 (0)161 831 1512
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 will enter clinical trials in early 2010.
Treating cancer by vaccination allows small non-toxic doses of a vaccine to be
administered to a patient, stimulating an immune response. Effective cancer
vaccine 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 DNA vaccine encoding 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 can effectively target dendritic
cells via their Fc receptors, allowing efficient stimulation of high avidity
and high frequency 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.
About Ichor
Ichor Medical Systems' TriGridâ„¢ Delivery System is the first integrated and
fully automated system for electroporation-mediated DNA administration. Ichor,
a privately-held biotech company based in San Diego, CA, is collaborating with
partners on three continents in a wide range of studies to test the TriGridâ„¢ as
an enabling platform for delivery of DNA drugs and vaccines to treat diseases
such as pandemic flu, hepatitis, HIV, melanoma, multiple sclerosis, and others.
The TriGridâ„¢ is also being tested by the U.S. military as an efficient means of
delivering anti-bioterrorism agents.
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