Neurex Corp. has initiated Phase II clinical trials for development of itsneuron-specific calcium channel blocker, SNX-111, in the treatment ofischemia, which causes brain damage in cases of head trauma andcoronary artery bypass surgery.Separate studies will be conducted for head trauma patients and thoseundergoing bypass operations. In both cases, SNX-111 will be infusedintravenously in an effort to prevent consequences of ischemia, whichresults in poor blood supply and lack of oxygen to the brain.Neurex CEO Paul Goddard said the progression to Phase II clinicaltrials triggered milestone payments to Neurex from its corporatepartner, Warner-Lambert Co., in the amount of $1 million. Last yearWarner-Lambert, of Morris Plains, N.J., made an equity investment inNeurex and agreed to share in development costs for SNX-111.In addition, Neurex, of Menlo Park, Calif., said Tuesday it filed aninvestigational new drug application with the FDA to begin Phase I/IIclinical studies of SNX-111 in the treatment of pain in advanced cancerand AIDS patients.Goddard said that in battling pain and ischemia, SNX-111 works byblocking presynaptic calcium channels, which inhibits nerve cellcommunications and the release of over-excited neuro-transmitters.Each of the Phase II trials for treatment of ischemia will be double-blind and placebo-controlled. Patients receiving SNX-111 will get upto three different dosage levels and will be examined for safety andeffectiveness.The trial targeting head trauma will be conducted in hospitalemergency rooms and involve up to 75 patients. It is scheduled tobegin in Belgium and later expand to Holland and Great Britain.Patients will receive an escalating dosage during a 72-hour infusionfollowing treatment of their injuries.The other Phase II trial will involve 150 patients at various centers inthe U.S. The patients will receive 12-hour infusions of SNX-111 atdifferent doses while being prepped for coronary artery bypass surgery.A Phase I study for treatment of ischemia, which ended in March,involved 100 volunteers receiving 10 escalating doses. Goddard saidthe trial revealed SNX-111 to be safe and well-tolerated.The clinical trials involving SNX-111 for treatment of pain will beconducted in association with Medtronic Inc., of Minneapolis.Medtronic makes the implantable pumping device that will deliverSNX-111 to a specific pathway of the spine.Once the FDA approves the Phase I/II trial, 18 terminally ill patientswith advanced cancer or AIDS will receive five different doses and willbe monitored for safety and efficacy. The trial will be conducted atcenters on the West Coast of the U.S.Neurex and Medtronic signed an agreement earlier this year to developSNX-111 for treatment of pain syndromes. n
-- Charles Craig
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