BioCryst Reports Encouraging Preliminary Results from a Phase II Trial of its Lead Compound, BCX-34, for Topical Treatment of Psoriasis.BIRMINGHAM, Ala.--(HealthWire)--May 3, 1996--BioCryst Pharmaceuticals, Inc. (Nasdaq NM: BCRX) today announced encouraging preliminary results from a Phase II trial of its lead compound, BCX-34, for the topical treatment of psoriasis. The Phase II double-blind, placebo-controlled trial treated 90 patients with plaque psoriasis for three months with a topical cream containing one-percent drug concentration of BCX-34. The endpoints for the trial were reductions in erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. , scaling and thickness of plaques, which were combined for a total score, and a global physician assessment. The trial had two parallel patient groups, one receiving drug and the other receiving placebo. The preliminary data from this trial will be summarized in conjunction with previous 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 data at the 57th Annual Meeting of the Society for Investigative Dermatology being held May 1-4 in Washington, D.C. The trial was conducted at four geographically diverse sites: two in northern climates and two in the Sunbelt. Analysis of the combined data from all sites did not reveal a clear drug effect different from placebo; however, there was a statistically significant difference in the data from the northern and Sunbelt patient groups which did not allow for a meaningful comparative analysis of the combined data from all sites. Consequently, the two regions were analyzed separately. Data from the northern sites showed a statistically significant outcome for the total clinical score and the global physician assessment after 12 weeks of treatment. In the Sunbelt sites, there was a large response in placebo-treated patients, which masked any apparent drug effect. The difference in placebo responses between the sites in the north and the sites in the Sunbelt is believed by the Company to have been caused by the phototherapeutic effect of the sun in southern climates. There was no significant adverse events reported at any of the four sites. "Data from the northern sites support the clinical efficacy of BCX-34 for the topical treatment of psoriasis," said George A. Omura, M.D., Vice President, Clinical Development of BioCryst. "The elevated placebo response in the Sunbelt sites, in our opinion, is attributable to increased exposure to the warmer climate and sunlight, which has a well-known therapeutic effect on skin conditions such as psoriasis." "We have gained valuable clinical data from these trials and are satisfied that the results warrant advancing BCX-34 to the next stage of development," said Charles E. Bugg, Ph.D., President and Chief Executive Officer of BioCryst. "We will request a meeting with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to discuss the design and initiation of Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials. These next trials will be designed to compensate for phototherapeutic and other non-drug related effects, and give a definitive assessment of the drug's efficacy and safety." Psoriasis is a chronic and recurrent disease characterized by red, thick scaling or welt-covered portions of the skin. An estimated five million people in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. are affected by psoriasis. Current therapies for psoriasis are not optimal or are associated with side effects Side effects Effects of a proposed project on other parts of the firm. . The Company is currently conducting a multi-center Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the with topical BCX-34 for the treatment of cutaneous T-cell lymphoma Cutaneous T-Cell Lymphoma Definition Cutaneous T-cell lymphoma (CTCL) is a malignancy of the T-helper (CD4+) cells of the immune system. Description (CTCL CTCL Cutaneous T Cell Lymphoma ) and a Phase I/II clinical trial with an oral formulation of BCX-34 to treat T-cell cancers. These diseases and others, including rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. , multiple sclerosis and psoriasis, are associated with the proliferation of T-cells. Based upon the results of the ongoing Phase I/II oral trial, BioCryst plans to initiate oral trials for additional indications including the treatment of psoriasis. BCX-34 is a potent, small-molecule inhibitor of purine nucleoside phosphorylase Purine nucleoside phosphorylase (also known as PNPase) is an enzyme (EC 2.4.2.1) involved in purine metabolism. PNP metabolizes inosine into hypoxanthine and guanosine into guanine, in each case creating ribose phosphate. (PNP), a human enzyme that plays a central role in the proliferation of T-cells. BCX-34 was granted Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the Status in October 1993 for CTCL and qualifies for accelerated review as a new drug to treat serious and life-threatening illnesses. Except for the descriptions of historical facts contained herein, this news release contains forward-looking statements that involve risks and uncertainties as detailed from time to time in BioCryst's SEC filings under the Securities Act of 1933 and the Securities Exchange Act of 1934, including, among other things, uncertainties as to the clinical and commercial success of BCX-34, and competitive, patent, regulatory and product liability issues. The trial outcomes discussed in this press release are not necessarily predictive of the results of future trials. Founded in 1986, BioCryst Pharmaceuticals, Inc. designs and develops novel, small-molecule pharmaceuticals using structure-based drug design, an approach to drug discovery that integrates advanced biology, biophysics biophysics, application of various methods and principles of physical science to the study of biological problems. In physiological biophysics physical mechanisms have been used to explain such biological processes as the transmission of nerve impulses, the muscle and medicinal chemistry. BioCryst's lead drug, BCX-34, is in clinical trials with both topical and oral formulations. The Company is developing drug treatments for immunological and infectious diseases. CONTACT: BioCryst Pharmaceuticals, Inc. John L. Higgins Vice President of Corporate Development 205/444-4600 or Burns McClellan, Inc. James W. Heins (Media) Jonathan M. Nugent (Investors) 212/505-1919 |
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