Clinical Trial of PVAC™ with UVB in New Zealand
Genesis Research Announces Commencement of Clinical Trial of PVAC™ with UVB in New Zealand
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 it has commenced a new clinical study designed to evaluate the potential effectiveness of PVAC™ treatment in conjunction with UVB (Ultra Violet-B) light for patients with mild to moderate plaque psoriasis.
In this double-blind, randomised, placebo-controlled study, patients aged 16 to 70 with mild to moderate psoriasis will be randomised to two groups of approximately 30 patients each, which will be treated with UVB administered three times per week for eight weeks and either placebo or 15microgram dosage of PVAC™, administered at commencement and week 3. Final efficacy evaluation will be conducted at 20 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 opportunity to explore the efficacy of PVAC™ as an adjuvant treatment for patients suffering from mild to moderate levels of psoriasis,” stated Dr Jim Watson, Chief Executive of Genesis.
The initiation of this study follows observations by US clinicians in a previous Phase II study that some patients who did not initially respond to PVAC™ and returned to standard UVB light treatment, then showed more pronounced improvement than they had previously achieved with UVB light therapy. Sunlight is known to have an effect on the immune system and UVB is a recognised psoriasis treatment.
Genesis Research and Corixa Corporation, 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.
Phase II clinical trials are currently being held in USA, Brazil and Philippines.
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.
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.
For more information, please visit www.genesis.co.nz
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