Neoprobe Corp. said late Tuesday that it's on schedule forcompleting pivotal U.S. Phase III trials of its radioimmunoguidedsurgery (RIGS) product for colorectal cancer.The Dublin, Ohio, company said it has enrolled about two-thirds ofthe 408 patients needed to complete the two Phase III studies. Withthe news, Neoprobe said it expects to complete trials by the end ofthe first quarter in 1995, and submit applications for marketingapprovals in the U.S. and Europe shortly thereafter.One of the U.S. trials is for primary colorectal cancer, the other formetastatic colorectal cancer. Neoprobe is seeking regulatoryapproval for Phase III testing of the RIGS product for colorectalcancer in Europe, and anticipates starting the study in the nextmonth, Judy Barnes, the company's manager, corporatecommunications, told BioWorld. Additionally, Phase III patientenrollment has begun in Israel."We feel the clinical trials are moving quickly compared with howthey could go," Barnes said. "We're getting close to ending ourpivotal trial."Data from the U.S. and European trials will be combined forsubmission to the respective regulatory agencies, Barnes said.The RIGS system, used to detect cancer, involves injecting a patientwith a low-level radioactive monoclonal antibody or peptidedesigned to adhere to cancer cells or antigens. During surgery aphysician uses the RIGS gamma detector to search for radioactivityin specific tissue, indicating the presence of cancer.The RIGS system for colorectal cancer uses a monoclonal antibodylabeled with Iodine-125.Neoprobe said it completed the transfer of radiolabeling of themonoclonal antibody to Nordion International in Kanata, Ontario,from The Dow Chemical Co., of Midland, Mich., which still ismanufacturing the antibody. But Neoprobe is preparing to transferthe manufacture of the antibody to NewMonoCarb AB, a Swedishmanufacturing company acquired by Neoprobe in April. And itplans to establish a radiolabeling facility through an Israelisubsidiary, which would radiolabel the antibody for European sales."The point of all this is to gain strategic control of themanufacturing of the drug," Barnes said. "We are carrying onconversations with companies and looking for strategic partners tohelp with the marketing and distribution for the commercializedRIGS products."Completion of Phase III enrollment for the colorectal indication willbring to 1,500 the number of patients treated with RIGS products,which are in Phase II testing in the U.S. for ovarian and breastcancer.Neoprobe also has two therapeutic products in clinical testing basedon its RIGS/ACT (adoptive cellular therapy) technology. A productfor metastatic colorectal cancer is in Phase I/II clinicals and one forpancreatic cancer is in a pilot study. ACT is an experimentaltherapy that uses a patient's own immune cells.n
-- Jim Shrine
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