BIOCRYST COMPLETES BCX-4208 PHASE I TRIAL FOR PSORIASIS.
BioCryst Pharmaceuticals, Inc., Birmingham, Ala., has announced that BCX-4208 has successfully completed a Phase I, placebo-controlled, single ascending dose, pharmacokinetic and safety trial involving 84 healthy volunteers. The study, which evaluated the pharmacokinetic profile for this oral formulation, measured BCX-4208 inhibition of the target enzyme purine nucleoside phosphorylase Purine nucleoside phosphorylase (also known as PNPase) is an enzyme (EC 22.214.171.124) involved in purine metabolism. PNP metabolizes inosine into hypoxanthine and guanosine into guanine, in each case creating ribose phosphate. (PNP), and included detailed safety evaluations of renal and liver function, hematologic hematological, hematologic
pertaining to or emanating from blood cells.
total and differential white cell counts, hematocrit estimation, erythrocyte count. parameters, immunological markers, and cardiac function as measured through continuous ECG monitoring, including detailed QTc evaluations.
Results from this Phase I study indicate that single doses of BCX-4208 ranging from 0.5 mg/kg to 3 mg/kg were well-tolerated among the broad spectrum of safety parameters being monitored. Additionally, BCX-4208 achieved a dose-related inhibition of PNP, which effectively increases the serum level of deoxyguanosine that is necessary for selective suppression of T-cell activation.
Based on these positive results, BioCryst intends to initiate a randomized, double-blind, escalating multi-dose Phase I trial with BCX-4208 to further evaluate its safety profile and pharmacokinetics in approximately 60 healthy volunteers beginning in the second quarter of 2005. "The results from our first trial are very encouraging, and we are committed to the development of BCX-4208 for the treatment of psoriasis and other T-cell mediated conditions where an oral therapy offers clear advantages and might greatly improve patient quality of life," stated Dr. Charles E. Bugg, chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of BioCryst.
Psoriasis is a chronic skin disease that affects more than seven million Americans, according to the National Psoriasis Foundation The National Psoriasis Foundation is a patient-driven, non-profit US-based psoriasis education and advocacy group. The National Psoriasis Foundation's mission is to improve the quality of life of the millions of Americans with psoriasis and/or psoriatic arthritis by promoting . Approximately 30% of people with psoriasis under a physician's care are estimated to have moderate to severe forms of the disease. Furthermore, it is estimated that the prevalence of psoriasis in Western Europe is approximately 14 million people and approximately 74 million people in Asia, according to Scrip and NIH "Not invented here." See digispeak.
NIH - The United States National Institutes of Health. reports in 2003.
BCX-4208 is BioCryst's second generation, more potent transition-state analog inhibitor of PNP. The complex of BCX-4208 and PNP has a long half-life (approximately 8 days) with suitable oral bioavailability, which supports BCX- 4208 as a good candidate for chronic dosing in autoimmune diseases such as psoriasis. The clinical development program for BCX-4208 is being conducted under an Investigational New Drug Application filed with the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. for treatment of psoriasis. In addition to psoriasis, BioCryst intends to investigate the potential of BCX-4208 for the treatment of other clinical conditions that are believed to involve T-cell activation, including rheumatoid arthritis, Crohn's disease and transplant rejection.
BioCryst Pharmaceuticals, Inc. designs, optimizes and develops novel drugs that block key enzymes involved in cancer, cardiovascular diseases, autoimmune diseases, and viral infections. BioCryst integrates the necessary disciplines of biology, crystallography, medicinal chemistry and computer modeling to effectively use structure-based drug design to discover and develop small molecule pharmaceuticals. BioCryst's first lead product candidate, forodesine hydrochloride (BCX-1777), another transition-state analog inhibitor of PNP, is currently in a Phase IIa trial for patients with T-cell malignancies and a Phase I trial with oral forodesine hydrochloride in 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). BioCryst also plans to initiate a Phase I/II trial in B-cell acute lymphoblastic leukemia acute lymphoblastic leukemia
n. Abbr. ALL
Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia. during the first half of 2005. Forodesine hydrochloride has been granted Orphan Drug status by the U.S. Food and Drug Administration for three indications: T-cell non-Hodgkin's lymphoma, including CTCL; chronic lymphocytic leukemia chronic lymphocytic leukemia
n. Abbr. CLL
Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. (CLL CLL
chronic lymphocytic leukemia
n.pr See leukemia, chronic lymphocytic.
CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid ) and related leukemias including prolymphocytic leukemia, adult T-cell leukemia Human T cell leukemia/lymphotropic virus type 1 (HTLV-1) is believed to be the cause of several diseases, including adult T cell leukemia/lymphoma (ATLL), a rare cancer of the immune system's own T-cells. , and hairy cell leukemia Hairy Cell Leukemia Definition
Hairy cell leukemia is a disease in which a type of white blood cell called the lymphocyte, present in the blood and bone marrow, becomes malignant and proliferates. ; and for treatment of acute lymphoblastic leukemia (ALL). Following successful completion of Phase I clinical trials with its second generation PNP inhibitor, BCX-4208, BioCryst plans to initiate a Phase II study in psoriasis during the second half of 2005. In addition, BioCryst is advancing two preclinical programs in the area of hepatitis C polymerase and tissue factor/factor VIIa.
For more information, visit http://www.biocryst.com .