CeNeS To Begin Phase III Sipatrigine Trial For Stroke In 2000
Executive Summary
CeNeS anticipates beginning Phase III trials in 2000 for the former Glaxo Wellcome stroke compound sipatrigine.
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CeNeS anticipates beginning Phase III trials in 2000 for the former Glaxo Wellcome stroke compound sipatrigine. The company is conducting a Phase II imaging study with the sodium channel blocker. The trial is expected to be completed in approximately 18 months. Under a deal announced April 15, Glaxo licensed sipatrigine (formerly 619C89) to Cambridge, U.K.-based CeNeS for an undisclosed license fee and milestone payment. The compound was originally part of the Wellcome pipeline, and Glaxo had initiated a Phase II program prior to the outlicensing deal. Glaxo has recently touted its late-stage glycine antagonist GV150526 for ischemic and hemorrhagic stroke, which is slated for filing in 2000. A dose-finding study conducted in stroke patients was published in 1998. Sipatrigine was associated with CNS side effects (hallucinations) under a regimen of 2 mg/kg loading followed by 1 mg/kg every eight hours. GI upset and confusion were also seen with the drug, a study abstract says. Lower doses were well-tolerated. Glaxo retains the option to commercialize sipatrigine following completion of Phase III trials in exchange for royalty payments to CeNeS. CeNeS has the right to either market sipatrigine or sub-license the drug to a third party if Glaxo does not exercise its option. Glaxo will also purchase a minority equity stake in CeNeS as part of the agreement. Sipatrigine will be one of the lead projects in CeNeS' portfolio. Other projects at the company include a series of dopamine D1 antagonists licensed from Novo Nordisk in 1997. CeNeS has candidates in Phase I and Phase II for schizophrenia. A neuropathic pain indication is being considered for two novel analgesic tripeptides that CeNeS in-licensed in 1997 from Bio-Technology General. Compounds CEE 04-420 and CEE 04-421 are in pre-clinical development. CeNeS is also pursuing a post-operative pain indication with the morphine-6-gluconuride compound CEE 04-410, which is entering a Phase II dose-ranging study this year. |