Astralis Announces Presentation of Phase II Results at 66th Society for Investigative Dermatology Meeting FAIRFIELD, N.J., May 6 /PRNewswire-FirstCall/ -- Astralis Ltd (OTC:ASTR) (BULLETIN BOARD: ASTR) announced today that the results of its 120 patient, 11 site, multi-dose Phase II clinical trial of Psoraxine(R), its product for the treatment of psoriasis, was presented at the Society of Investigational Dermatology meeting in St. Louis, MO, on Friday, May 6, 2005. The report authored by Dr. James Kreuger, Professor and Medical Director of Investigative Dermatology at Rockefeller University, and Dr. Bruce Miller, MD at Oregon Medical Research Center, presents both PASI (Psoriasis Area Severity Index) and patient biopsy results, respectively the primary and secondary endpoints of the trial. Although the six injection, twenty week trial of Psoraxine(R) did not demonstrate a statistically significant clinical improvement in PASI scores compared to placebo, the trial again confirmed the safety of the product for human use. Upon more detailed analysis of both PASI and biopsy results, the Company has observed specific data that has led it to conclude that the product is active, although not at the level it expected. Following analysis of the clinical trial design, manufacturing process and product formulation data, Astralis has identified several factors including the limited number of injections used and the formulation of the active components of the product that may have contributed to the unexpected results of the Phase II trial. Based on these analyses, the Company remains committed to the development of Psoraxine(R), and is embarking on a program to improve the performance of its treatment for psoriasis. "We continue to be encouraged by the safety profile demonstrated by the product", remarked Dr. Jose O'Daly, Chairman and CSO of Astralis. "In 140 patients in two clinical trials in the United States no serious adverse events related to the product were reported. The demonstrated lack of significant side-effects in the United States trials and in prior Venezuelan trials suggests we can continue clinical testing of our current product, AS210, while we also work on improving its efficacy". The most commonly reported adverse events were headache, and injection site pain and tenderness. With respect to the trial's overall results, Dr. Gordon Schooley, Chief Scientific Officer of SkyePharma and a member of Astralis' Board of Directors, said "Despite the lack of statistically significant differences in PASI scores, the primary endpoint, the performance of a 300 microgram dose of AS210 appeared more active than either of the other two doses of AS210. We are hopeful that changes in the protocol such as optimizing the administration technique and dosing regimen can improve product efficacy in the treatment of psoriasis." James Sharpe, President & CEO of Astralis said that "Astralis continues to believe that the results seen previously in Venezuela can be reproduced in the United States, and feels that the Phase II data provides important information about the active components, formulation, dosing frequency and other variables necessary to optimize the product's performance". This press release may contain forward-looking statements regarding Astralis Ltd. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that PSORAXINE(TM) will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release. Notes to the Editor Astralis Ltd, a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine(TM), the company's first product candidate, is an innovative drug under development for psoriasis, and is based on the discovery of a proprietary protein extract. For more information, visit Astralis' web site at http://www.astralisltd.com/. Psoriasis Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world's population. Psoriasis symptoms result from the overproduction of skin induced by blood cells associated with the immune system. These blood cells are over- stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause a range of symptoms including itchy rash like patches, painful pustules and massive inflammation. Additional information can be obtained from: US National Psoriasis Foundation at http://www.psoriasis.org/ International Federation of Psoriasis Associations at http://www.ifpa-pso.org/ DATASOURCE: Astralis Ltd CONTACT: Astralis Ltd, +1-973-227-7168, or fax, +1-973-227-7169, Web site: http://www.psoriasis.org/ Web site: http://www.ifpa-pso.org/ Web site: http://www.astralisltd.com/

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