• Neoprobe (Dublin, Ohio) said that its subsidiary, Cira Biosciences, has received an independent technology assessment report on its activated cellular therapy (ACT) technology. The assessment was performed by the Battelle Memorial Institute (Columbus, Ohio) to review the cell processing procedures and manufacturing processes used by Cira Biosciences in earlier ACT clinical trials that provided positive clinical results. The Battelle report indicates that the ACT cell processing technology would be commercially feasible and reproducible with Cira’s implementation of the recommended Battelle process and procedure development initiatives. Battelle also identified a number of laboratory processing and handling procedures that could be consolidated thereby improving cell-processing efficiency and potentially reducing processing costs. Cira’s scientific advisors recommended that it would be appropriate to initiate a Phase II study under Neoprobe’s corporate investigational new drug application for end-stage colorectal cancer and to initiate a separate Phase I study for pancreatic cancer. In addition, Cira’s viral disease consultants have recommended that the technology should be evaluated in African-American hepatitis C patients because of the significant difference in treatment efficacy rates of currently used treatment methods between African-American and Caucasian patients. Finally, the clinicians who evaluated the technology in patients with chronic fatigue syndrome are seeking institutional clearances to complete a five-year follow-up on the treated patients who responded to the ACT therapy.
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