Neurobiological Technologies Inc. is beginning three clinical trialswith its lead compound, corticotropin-releasing factor (CRF), fortreatment of peritumoral brain edema and rheumatoid arthritis.The Richmond, Calif.-based company is conducting two Phase I/IItrials of the anti-inflammatory peptide for treatment of swellingcaused by brain tumors. Both trials, involving 30 patients, will testsafety and efficacy. A third Phase I/II trial of CRF will study itseffect on six rheumatoid arthritis patients.Neurobiological's chief financial officer, John Harland, toldBioWorld one CRF trial, an open-label study involving 10peritumoral brain edema patients, is being conducted at theMemorial Sloan-Kettering Cancer Center in New York. Patientswill receive either an intermittent bolus of CRF or a continuousinfusion for seven days.In the other trial, a double-blinded, placebo-controlled study underway at the Cancer Therapy and Research Center in San Diego, 20patients will get a one-day treatment. Harland said eight patientshave been enrolled and investigators plan to expand the trial toinclude a three-day treatment.In both trials, brain swelling will be measured with magneticresonance imaging scans before and after treatments. Harland saidthe studies should be complete in four to six months.The third trial of CRF for rheumatoid arthritis is being held at theUniversity of California, San Diego, Medical Center. Patients, whohave received no treatments of any kind for two days, will getvarying doses of CRF over three days and will be monitored forthree more days.CRF is produced by the brain's hypothalamus. As part of theneuroendocrine-immune regulatory network, it stimulates release ofcorticosteriods. Neurobiological reported in animal trials injectionsof CRF inhibited acute inflammatory response, such as brain edemafollowing injuries and tissue swelling caused by surgical incisions.Neurobiological also has clinical trials of CRF under way for acuteasthma, post surgical edema and reduction of swelling followingcosmetic eye lid surgery.Harland said the company has $12.5 million in cash, enough to lastfor two fiscal years, and is talking with potential corporate partnersto help finance later stage clinical trials.Neurobiological went public in February and has 4 million sharesoutstanding. The company's stock (NASDAQ:NTII) closed Fridayat $4, unchanged. n
-- Charles Craig
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