The mission of Stage I Diagnostics is to commercialize a test system that can detect cancers in the earliest stages of the disease – in effect, in stage I of the disease. We believe that there is a significant market need for reliable early stage screening tests for cancers of the reproductive tract, and especially, ovarian cancer. Currently, ovarian cancer is only rarely detected in its early stages. However, detection in stage I of the disease greatly enhances the treatment outcome for patients as evidenced by the data in the accompanying chart. Using current technology, only about 20% of all women have their ovarian cancers detected in stages I and II of the disease, where it is the most treatable. According to the American Cancer Society, of the 80% of women whose cancers are not detected until stages III and IV, only 20% survive for longer than five years. Ovarian cancer rarely exhibits noticeable symptoms until it progresses to its latter stages and because of this, it is known as the “silent killer.” There is a compelling need to develop reliable, accurate test systems to detect ovarian cancer at its earliest stages, when treatment options provide women a fighting chance at long term survival.
Stage I has an advantage in the development of screening tools for cancers of the ovary, prostate, breast and cervix because of the breadth of our intellectual property. We currently possess in-licensed proprietary rights to 14 tumor markers that we have identified as being present in all four types of cancers that we have targeted. Some of these antigens are also present in more than one type of cancer. Stage I can use a panel of antigens to detect cancer in patients instead of relying on just one single antigen and also develop several panels that cover different cancer types from this set of tumor markers. By using a properly selected panel in our test systems, we believe our test systems’ reliability will be superior to a single marker test.
The table below provides a list of the tumor markers in our portfolio and the diseases in which they are prevalent. As of June 30, 2004, we had licensed the rights to 14 issued United States patents; 6 issued foreign patents, 21 pending United States patent applications, and 10 pending foreign applications. Our pending foreign filings will cover Europe, Japan, North America and Australia.
The table below provides some preliminary data from pre-clinical analyses of 53 early and late stage ovarian tumors, which span the four major ovarian cancer tumor types. Analysis of the data contrasts our panel of markers with the CA125 test system. CA125 is the current marker of choice for ovarian cancer. Among our group of markers, while no single one is present in all of the tested tumors, the marker group treated as a panel or array is present in all of the 53 tested early stage tumors. As shown in the following table, the success rate in detecting all tumor types, using CA125 alone, could be significantly lower than the success rate of the entire group of markers comprising Stage I’s OvaStage™ test system.
Our solution to the market need for more reliable early stage screening tools for cancers is to use a panel of markers in our test systems. Using a panel improves our chances for early detection of a tumor. Tumors have individual marker profiles and as such several markers are necessary to accurately detect early stage disease. With ovarian cancer there are four distinct major tumor types. Each of these types produces a varying set of markers with some markers present in one type and absent in another. The levels of expression of the markers are also very different from type to type. Our panel, constituting the OvaStage™ test system and consisting of all of the markers in the table above, including CA125, covers all four of the major types of ovarian cancer. By using the OvaStage™ panel, we believe that we can greatly improve detection capabilities, enabling earlier and better treatment outcomes for the great majority of ovarian cancer patients.
ProStage™ will be our product for the early detection of prostate cancers. ProStage™ will consist of a panel of our tumor markers that will enable us to detect prostate cancer in its earliest stages and also to discern the difference between benign prostate disease and malignant tumors. We know that a number of our markers are prevalent in prostate cancer and we are conducting preclinical work to determine the optimum panel to allow early detection of malignancy. |
