IRVINE, Calif. and NYON, Switzerland, Jan. 8 /PRNewswire/ -- Xytis announced today that it has signed a $40 million Cooperative Research and Development Agreement (CRADA) with the National Institutes on Drug Abuse (NIDA) to test the hypothesis that Neboglamine can facilitate abstinence from cocaine or prevent relapse in cocaine addiction. The CRADA is subject to the completion of on-going multiple-dose escalating safety and tolerability studies being conducted by Xytis and to safety studies evaluating the interaction of cocaine and Neboglamine in animals and humans that will be conducted by the National Institute of Drug Abuse (NIDA).
Neboglamine is a new potential anti-psychotic agent that has been shown to improve cognitive performance and which has anxiolytic and anti-depressive activity in preclinical animal models. Xytis recently completed single dose escalation and food interaction Phase I studies with Neboglamine. These study results indicate that Neboglamine is safe and well-tolerated within the dose range that is expected for efficacy. The multiple-dose escalation study is expected to be completed during the second quarter of 2007. In addition to assessing safety and tolerability, volunteers will be evaluated for 24hr quantitative EEG changes, sleep architecture in polysomnography recordings, 24 hour Holter ECG, and a series of psychometric tests. Evaluating the pharmacodynamic effect of Neboglamine on these physiological variables is expected to help selecting the most responsive target patient population with schizophrenia, and possibly cognitive-dysfunction and depression co-morbidity, in Phase II studies. The dose escalation study is being conducted by FORENAP Pharma in Rouffach, France.
Werner Tschollar, MD, Xytis’ CMO stated: “The collaborative research project with NIDA on Neboglamine addresses a significant public health problem. Chronic cocaine abuse can lead to neurobiological changes and as a consequence to behavioral alterations, cognitive dysfunction, psychosis, and depression. We believe that Neboglamine has the therapeutic potential to treat cocaine addiction.”
About Xytis:
Xytis Inc. is a biopharmaceutical company focusing on the discovery and development of innovative CNS drug candidates. The company is privately held and has received funding from Atlas Venture, Sanderling Ventures, CDC Entreprises Innovation, and Ventech. Xytis’ other clinical compound, Anatibant (XY2405) is in a Phase II clinical trial for traumatic brain injury (TBI). The first patient in the TBI trial is expected to be enrolled this month. Xytis has a rich portfolio of proprietary preclinical compounds that are novel, highly selective allosteric modulators of nicotinic Acetylcholine Receptors (nAChRs), GABA-A receptors and other well-validated CNS targets. Xytis’ drugs are currently in investigational clinical trials and have not been approved for the treatment of any disease.
Xytis Pharmaceuticals, Inc.
CONTACT: Werner Tschollar, MD, Chief Medical Officer, +41-22-365-5100,wtschollar@xytis.com; or Vincent F. Simmon, Ph.D., CEO, +949-226-1118,vsimmon@xytis.com
Web site: http://www.xytis.com/
