Astralis Initiates U.S. Phase II Clinical Trial for Psoraxine for the Treatment of Psoriasis.Business Editors/Health/Medical Writers FAIRFIELD, N.J.--(BUSINESS WIRE)--March 29, 2004 Astralis Ltd (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : ASTR ASTR American Society for Theatre Research (established in 1956) ASTR Aerospace Systems Test Reactor ASTR Aircraft Shield Test Reactor ASTR Automatic Spectral Target Recognition ASTR Army Specialized Training Reserve ) announced today that the Company has begun its Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II for Psoraxine(R). The trial, a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double blind, placebo controlled study, will evaluate the safety and efficacy of repeated administrations of Psoraxine(R), for patients with moderate to severe plaque psoriasis. The Company anticipates that a total of 120 patients at 10 clinical sites in the U.S. will participate in the study. Each patient will receive a series of 6 intramuscular injections, once every two weeks, and subsequently will be evaluated for an additional 8 weeks without treatment. The primary objective is to evaluate the safety and efficacy of multiple administrations of Psoraxine(R) at three alternative dose-levels, compared to a placebo. The Company will also seek, through the study, to detect and evaluate specific immunological changes, which may be induced by the repeated exposure to Psoraxine(R) and to generate information necessary for a better understanding of the drug's mechanism of action. Psoraxine(R) is a protein-based therapy that is believed to act as an immunostimulator, rather than an immunosuppressor. The Company has completed a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in patients with moderate psoriasis and no adverse events related to Psoraxine(R) were reported. This press release may contain forward-looking statements regarding Astralis Ltd including with respect to the objectives, intentions, and expectations relating to the studies. 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(R) 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, an emerging biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. disorders and skin diseases. Psoraxine(R), the company's first product candidate, is an innovative drug under development for the treatment of psoriasis, and is based on the discovery of a new gene sequence of proteins. For more information, visit Astralis' web site at www.astralisltd.com. Psoriasis. Psoriasis is a chronic, genetically based remitting and relapsing scaly scal·y adj. 1. Covered or partially covered with scales. 2. Shedding scales or flakes; flaking. scaly skin condition characterized by scales; scalelike. and inflammatory skin disorder that affects approximately 3% of the world's population. Psoriasis symptoms result from the overproduction o·ver·pro·duce tr.v. o·ver·pro·duced, o·ver·pro·duc·ing, o·ver·pro·duc·es To produce in excess of need or demand. o of skin by blood cells blood cells, n.pl the formed elements of the blood, including red cells (erythrocytes), white cells (leukocytes), and platelets (thrombocytes). blood cells See erythrocyte and leukocyte. Platelets are classed separately. 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 everything from itchy rash like patches to painful pustules and massive inflammation. |
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