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Genesis Announces New U.S. Clinical Trial of PVAC™

Genesis Announces New U.S. Clinical Trial of PVAC™
Randomised, Blinded and Controlled Trial to Evaluate Improvement of Disease Severity in Patients with Mild to Moderate Psoriasis

Genesis Research and Development Corporation Ltd (NZSE/ASX: GEN) today announced that Corixa Corporation has initiated an additional U.S. clinical study designed to evaluate the potential effectiveness of PVAC™ treatment for patients with mild to moderate plaque psoriasis.

In this double-blind, randomised, placebo-controlled study, patients with mild to moderate psoriasis will be randomised to one of four groups. Individual groups (approximately 60 patients each) will be treated with either placebo or one of three different dosages of PVAC™ (2, 15, or 50 micrograms). Four doses will be given over a 15-week period, with final efficacy evaluation to be conducted at 23 weeks. Efficacy end points will include improvements in disease severity as assessed by decrease in baseline PASI (psoriasis area and severity index) scores. PVAC™ treatment or placebo will be administered via intradermal injection.

“This trial provides an excellent opportunity to continue our examination of the safety and efficacy of PVAC™ as a treatment for patients suffering from mild to moderate levels of psoriasis,” stated Dr Jim Watson, Chief Executive of Genesis. “The initiation of this study incorporates findings from previous Phase II studies and is an important step in the potential development of PVAC™ treatment as a novel therapeutic for the management of psoriasis. It will allow us to expand our evaluation to different durations of therapy and will include patients who have not failed prior immunosuppressive therapies. The ability to expand our evaluation into patients with mild disease is based on the previously demonstrated benign safety profile of the therapy.”

Patients have begun enrolment at fourteen clinical sites in ten states across the continental United States.

Genesis Research and Corixa, in collaboration with licensed partners – Medicis Pharmaceutical Corporation and Zenyaku Kogyo Co. Ltd. – have developed PVAC™ as an immunomodulatory product candidate for treatment of mild to moderate psoriasis. PVAC™ is a derivative of Mycobacterium vaccae and was produced for U.S. IND studies at Corixa’s Hamilton, Montana facility.

About Psoriasis
According to the U.S. National Psoriasis Foundation, psoriasis is a chronic skin disease affecting more than seven million Americans, or about 2.6 percent of the U.S. population. About 150,000 to 260,000 new cases of psoriasis are diagnosed each year. Annual outpatient costs for treating psoriasis are currently estimated at approximately US$1.6 to US$3.2 billion. Psoriasis occurs when new skin cells grow too rapidly, resulting in inflamed, scaly skin lesions. Although the cause of psoriasis is unknown, researchers believe the increased activation, adhesion and passage of T-cells to the skin contributes to the inflammation and abnormal skin cell proliferation. Most current psoriasis therapies are palliative in nature and provide temporary patient benefit, or have significant side effects.

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.
Genesis’ 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 treatment of cancer and immune mediated diseases. 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 focusing 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.

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