Genesis Research Announces Results Of Phase I Safety Study In Atopic Dermatitis
Genesis Research and Development Corporation today announced that it had completed a Phase I safety study of AVAC™ for
the treatment of atopic dermatitis (also known as eczema) in adults, which showed that AVAC™ was safe and well
tolerated. This first adult trial of AVAC™ for atopic dermatitis is intended to lead to a study with children. A Phase I
study normally involves fewer than 50 volunteers. Its aim is to establish the compound’s safety.
Forty-four adults with long standing atopic dermatitis were enrolled in a double blind placebo controlled study
conducted in Wellington. There were no significant or serious systemic adverse events. The atopic dermatitis severity
score improved in the treated groups but did not show a statistically significant difference from the control group.
Immunological considerations support the view that the treatment of atopic dermatitis with AVAC™ during childhood is
more likely to result in therapeutic benefit. Now that the safety of intradermal administration of AVAC™ has been
established, Genesis will pursue its objective of carrying out paediatric trials of AVAC™, and is awaiting approval from
the Wellington Ethics Committee to conduct a safety study of AVAC™ in children with atopic dermatitis.
Genesis and its partner SR Pharma plc (LSE: SPA) are currently co-developing two potential therapeutics for atopic
dermatitis. A Phase II paediatric atopic dermatitis trial in New Zealand will follow the planned tolerability study in
children. The companies are also planning to conduct a Phase II trial of SRP299TM in childhood atopic dermatitis in the
United Kingdom starting later this year. When these trials have been completed the most effective candidate for further
clinical development will be selected. Genesis and SR Pharma are sharing the cost of these development programmes and
will jointly benefit from commercial returns associated with the subsequent licensing of the selected development
candidate. “Pooling our expertise with SR Pharma gives us a further treatment option for this distressing condition and
enables us to share future development costs,” says Genesis Chief Executive, Dr Jim Watson. “The collaboration builds on
our current asthma collaboration and strengthens the intellectual property of each company.”
About Genesis
Founded in 1994, Genesis is a New Zealand-based biotechnology company committed to the development of innovative
products in health and plant biotechnology from its broad genomic platform. Genesis partners with industry leaders to
develop products which have global market potential through the mining of its extensive microbe, plant and mammalian EST
databases.
The Health Sciences Division focuses on signalling pathways involved in immune diseases and cancer and has an extensive
patent portfolio. It has three programmes in human clinical development utilising PVAC™ and AVAC™ for the treatment of
psoriasis, atopic dermatitis (eczema) and asthma. Additional pre-clinical programmes are developing YB-1, FGFR5 and
Epigen as targets for novel treatments. The patented BioStore solutions for storage of tissues and living cells are also
in pre-clinical development. Collaborations are maintained with Immunex Corporation (NASDAQ: IMNX), Corixa Corporation
(NASDAQ: CRXA), SR Pharma (LSE: SPA), and Jurox Pty Ltd.
The Plant Sciences division is focussing on key cell signalling genes – novel hormones and transcription factors - to
control commercial traits including growth rates and wood fibre quality in trees, nutritional content of forage grasses,
flowering control, salt and cold tolerance. It has developed comprehensive plant EST databases including the world’s
largest EST database for commercial forestry species. It has research collaborations with ArborGen LLC, Wrightson (NZSE:
WRI), HortResearch, AgResearch and Landcare. Genesis is also undertaking significant unpartnered research programmes in
novel plant hormones. A number of patents are held including 12 steps in the production of lignin.
For more information, please visit www.genesis.co.nz
About SR Pharma
SR Pharma plc, a London based biopharmaceutical company founded in 1992, is committed to developing innovative medicines
based on an improved understanding of the role played by the immune system in combating disease. The company's
proprietary M. vaccae based technology is the source of a number of product developments. SRP 299™ is in clinical
development in asthma and atopic dermatitis. SRL172™ is being investigated in cancer and viral infections. These
products regulate immune responses associated with allergic disorders while enhancing those needed to combat cancer and
infection. The Company's web site can be found on www.srpharma.com