Neoprobe Corp. said Friday that it completed Phase IIItrials in Europe and the U.S. of RIGSscan CR49 for thedetection of metastatic colorectal cancer. Results weren'tavailable for release.

Patient enrollment for RIGS Phase III trials in primarycolorectal cancer has been completed in the U.S. but stillis ongoing in Europe. A company spokeswoman saidEuropean enrollment lagged behind that in the U.S.because of regulatory reasons.

"We've reached a really important milestone," JudyBarnes, Neoprobe's corporate communications manager,told BioWorld Today. "We've worked very hard to getthis far."

Barnes said the Dublin, Ohio, company expects to fileproduct approval applications for RIGSscan CR49 _ forthe metastatic indication _ in the U.S. at the end of thisyear, and in Europe in the first quarter of 1996.

"We've been gathering data as the patients completed the[metastatic] study, but we have to gather outstandingdata," Barnes said. "Once all the data are in-house we cando our analysis."

She said it would be premature to point to trends seen todate. "One of the things the FDA has told us is that weshould not look at the data until the study is complete andall sites are closed out because you have the danger ofadding bias to the study," Barnes said.

The RIGS products consist of a radioactive monoclonalantibody or peptide designed to adhere to cancer cells orantigens. During surgery a physician uses the RIGSgamma detector to search for radioactivity in specifictissue, indicating the presence of cancer. RIGS(radioimmunoguided surgery) for colorectal cancer islabeled with Iodine-125.

Barnes said 510 (k) marketing clearance for the gammadetector has been granted.

Neoprobe on Friday also reported its financial results forthe second quarter. It had a net loss of $2.6 million, and$11.9 million in cash and equivalents.

Barnes said the company's cash position is sufficient toget its first product on the market. Ideally, however,Neoprobe would like to find a corporate partner to helpwith the distribution and marketing of RIGSscan, Barnessaid. n

-- Jim Shrine

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