THE WOODLANDS, Texas, June 29 /PRNewswire-FirstCall/ -- Lexicon Genetics Incorporated (Nasdaq: LEXG) announced today that it has submitted a Clinical Trial Authorization (CTA) filing to the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) for LX6171, an internally- developed small molecule compound for cognitive disorders. Upon clearance by the MHRA, Lexicon intends to initiate a Phase 1 clinical trial of LX6171 in healthy volunteers to assess the compound's safety, tolerability and pharmacokinetics. In preclinical studies, LX6171 has demonstrated improved learning and memory in healthy and aged mice and has exhibited a good safety profile in toxicology and safety studies. Lexicon is developing LX6171 for potential application in the treatment of cognitive disorders such as Alzheimer's disease, schizophrenia, vascular dementia, attention deficit disorder and Fragile X syndrome.
"We believe LX6171 has the potential to enhance learning and memory for patients in need and we look forward to examining its effectiveness in human clinical trials," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer. "LX6171 is one of what we believe will be many proprietary molecules emanating from Lexicon's internal target and drug discovery efforts."
The target of LX6171 is a membrane protein that is expressed exclusively in the central nervous system. Its activity is associated with synaptic vesicles and presynaptic membranes. Lexicon discovered that mice lacking this protein displayed improved performance in tests of learning and memory, even as they aged. The Phase 1 clinical trial of LX6171 will be conducted at a site in the United Kingdom that was chosen for its significant experience examining human cognition in early-stage safety and tolerability studies.
In its Genome5000(TM) program, Lexicon is analyzing 5,000 genes using its proprietary gene knockout technologies and its extensive physiological and behavioral analyses to discover new drug targets from the human genome. To date, Lexicon has completed the analysis of approximately 3,500 of these genes and has harvested more than 90 promising targets related to major medical needs.
About Lexicon Genetics
Lexicon Genetics is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon is systematically discovering the physiological and behavioral functions of genes to identify potential points of therapeutic intervention, or drug targets. Lexicon makes these discoveries using its proprietary gene knockout technology to model the physiological effects that could be expected from prospective drugs addressing these targets. For targets that the company believes have high pharmaceutical value, it engages in programs for the discovery and development of small molecule, antibody and protein drugs. Lexicon has advanced knockout-validated targets into drug discovery programs in six therapeutic areas: diabetes and obesity, cardiovascular disease, psychiatric and neurological disorders, cancer, immune system disorders and ophthalmic disease. Lexicon is working both independently and through collaborations and strategic alliances to accelerate the development and commercialization of its discoveries.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's regulatory filings and clinical development program for LX6171 and the potential therapeutic and commercial potential of LX6171 and other potential drug candidates in Lexicon's preclinical pipeline. This press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to successfully conduct clinical development of LX6171 and preclinical development of other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Factors Affecting Forward-Looking Statements" and "Business -- Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2005, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Lexicon Genetics Incorporated