NZ Company to Trial Vaccine in US
Auckland, New Zealand – 13 January 2000 – New Zealand biotechnology company Genesis Research & Development today announced that its psoriasis vaccine, PVAC™, had passed a major milestone. Genesis, together with its development partner Corixa Corporation (NASDAQ: CRXA), a US vaccine-based biotechnology company, has received clearance from the US Food and Drug Administration (FDA) to initiate Phase II clinical trials to further study PVAC treatment of patients with moderate to severe psoriasis.
Psoriasis affects up to 100 million people worldwide. PVAC, a derivative of Mycobacterium vaccae (M. vaccae), is an immunomodulatory product for treatment of psoriasis. It will be produced for the US IND (Investigational New Drug application) studies at Corixa’s facility in Hamilton, Montana. Genesis and Corixa will conduct three random, placebo-controlled studies in the United States, Brazil and the Philippines
“This is an extremely important milestone, both for Genesis as a company, and in the development of PVAC as a novel therapeutic for managing psoriasis,” says Dr Jim Watson, Chief Executive of Genesis.
“What’s exciting for Genesis is that we have now taken PVAC, a discovery we made ourselves and developed in collaboration with Corixa, over a considerable hurdle in the world’s most stringent regulatory process.”
“Getting approval to begin Phase II trials represents the culmination of five years laboratory and clinical work and six months of regulatory processes. The trials proposed in the IND provide an excellent opportunity to continue to examine the safety and efficacy of the Genesis PVAC vaccine for patients suffering from this pervasive dermatological disorder.
"We anticipate that it may take up to two more years to complete this stage and be ready for Phase III. Only after the successful completion of the Phase III trials can the vaccine be launched as a product.
“To undertake this process with a discovery
that we made ourselves is unusual – often companies purchase
the original intellectual property that they take through
the testing cycle. The success to date of our partnership
with Corixa demonstrates the commercial potential of
Genesis’ discovery and partnership-based approach to
building and retaining a portfolio of intellectual
Impact and treatment of psoriasis
Psoriasis is characterised by chronic inflammatory lesions with red, scaling plaques, and is believed to be caused by immune attacks from the body’s own T-cells. The disease affects an estimated one to three percent of the world’s population. There are approximately five million people in the US with psoriasis, with an estimated 30 percent having a moderate to severe form of the disease.
Preliminary data from a pilot
Phase I trial performed in the Philippines were used in
Genesis’ and Corixa’s IND application. Approximately 20
moderate to severe psoriatic patients were treated in this
Phase I study. More than half of the patients treated
demonstrated greater than a 75 percent decrease in disease
severity. Many patients showed complete and durable
responses lasting for longer than the six months of
observation following administration.
In August 1999, Genesis announced that Japanese pharmaceutical company Zenyaku Kogyo has agreed to purchase limited rights to PVAC, for multi-year license, research and development in Japan. Genesis and Corixa retain exclusive rights for the rest of the world. Zenyaku Kogyo was the first party outside of the development partners to make a commitment to PVAC on the strength of its commercial potential.
Genesis Research and Development Corporation Limited is a discovery-based biotechnology company. Genesis has built a technology platform to identify new molecules that regulate the distribution of information during cell to cell communication common to all life systems, from humans to plants and micro-organisms. Commercial application of this technology extends the full range of life science industries, including health, forestry, agriculture and horticulture. The company’s business strategy, based on partnerships with biopharmaceutical, agricultural and forestry companies developing and marketing the products arising from the discovery programmes, has allowed Genesis to develop significant intellectual property. Genesis is based in Auckland, New Zealand and has been operating since 1994.
Corixa is a research and development-based biotechnology company committed to treating and preventing diseases by understanding and directing the immune system. Corixa applies its expertise in immunology and its proprietary technology platforms to the discovery and development of vaccine and other antigen-based products. The company partners with innovative developers and marketers of pharmaceuticals and diagnostic products to make its products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, Washington, with additional operations in Hamilton, Montana and Redwood City, California.
Photographs are available on request.
More information from:
Dr J.D. Watson, Chief Executive, Genesis Research and Development Corporation Limited
+64 9 373 5600, email@example.com
Sally Raudon, Botica Conroy and Associates, +64 9 303 3862, 021 402 502, firstname.lastname@example.org