Similar evidence of tolerability and activity have been reported with our wholly-owned TAP compounds. In Phase I clinical trials, cantuzumab mertansine was found to be well tolerated and evidence of anticancer activity was reported. For example, a patient with a large, diffuse, abdominal tumor had the signs of his disease all but disappear for more than a year with regular treatment with cantuzumab mertansine. A patient with treatment-resistant colon cancer had a marked reduction in the size of the tumors that had metastasized to her lungs. And a number of patients with treatment-resistant CanAg-positive cancer, including a patient with pancreatic cancer, experienced stable disease.
While less data have been reported to date with huN901-DM1, it, too, has been found to be well tolerated at doses that show evidence of anticancer activity. For example, a patient with a neuroendocrine cancer had a substantial, although transient, reduction in tumor size after receiving huN901-DM1, and additional patients experienced stable disease.
Looking forward, we expect the body of clinical data with TAP compounds to increase substantially through studies conducted by both us and our partners. On July 1, 2004, we assumed responsibility for the huN901-DM1 Phase I/II study underway in the US, and are working to expedite its completion. Patients with small-cell lung cancer (SCLC) are being enrolled in the Phase II leg of this study. Additionally, our former partner, Vernalis, is making progress with the Phase I study it initiated in SCLC in the United Kingdom.
We also plan to initiate our own clinical trial with huN901-DM1 in a hematologic malignancy, multiple myeloma. Preclinical work conducted at the Dana-Farber Cancer Institute confirms that a majority of multiple myeloma cases express CD56. The researchers also found that huN901-DM1 very effectively kills these multiple myeloma cells. We expect to begin our huN901-DM1 multiple myeloma clinical trial within the next six months. Demonstration of efficacy in such
a liquid tumor malignancy provides another possible route to marketing approval for huN901-DM1 that could be shorter than the one for SCLC.
Our other product candidate, cantuzumab mertansine, has undergone Phase I evaluation in studies completed by a former partner. We plan to initiate our own clinical program with this compound, and expect to test either cantuzumab mertansine, or a slightly modified version of it. We will provide details on our clinical study plans later in 2004.
While we are making progress with our clinical programs, our partners are also making progress with theirs. Millennium is now studying MLN2704 in Phase I/II trials. Outlicense partner Boehringer Ingelheim is studying its TAP compound, bivatuzumab mertansine, in multiple Phase I trials. Additionally, we expect Aventis, now a part of the Sanofi-Aventis group, to initiate clinical testing in the near future with the anti-CD33 TAP compound licensed from us.
We believe that the results from the studies we conduct with our own products, the results from the studies our technology outlicense partners conduct with their products, and the results from studies initiated by Aventis can all provide further validation for our technology.
Notice on Forward-Looking Statements
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