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OVANOME(TM)
Our scientists are working on a genomic-based diagnostic tool to match ovarian cancer patients with the most suitable form and dose of chemotherapy, particularly, Taxol-treated patients. Currently, cancer patients, especially women with breast and uterine cancer are treated with anti-cancer drugs whose efficacy is known in terms of population averages. In reality, individual cancer patients exhibit unpredictable and unique responses to virtually all commonly used chemotherapeutic compounds. Individual genetic differences have long been suspected to play a role in this variable drug response. For cancer patients, decisions about treatment regimes are often fateful, and second chances at treatment are usually unsuccessful. A better understanding of the relationship between genes and related chemistries and drug response can replace the current trial and error process of chemotherapy treatment. This new drug prescription strategy can help guide physicians and patients toward the optimal treatments at the outset of therapy.
We have completed our initial phase of research and development on a test to determine genetic predisposition for response to the Taxol-Carboplatin drug combination. The Taxol-Carboplatin drug combination therapy is a treatment for breast, ovarian, prostate and other cancers. In FDA clinical trials the Taxol-Carboplatin drug combination therapy demonstrated efficacy in only 60-70% of patients. In preliminary trials, our therapeutic response tests were 95% effective in distinguishing Taxol-Carboplatin responders from non-responders.
We had previously identified a number of SNPs and certain AIMs associated with variable Taxol/Carboplatin response in ovarian cancer patients. The markers were useful for stratifying ovarian cancer patients into two groups: patients that will respond to Taxol as intended, with essentially no risk of non-response, and patients that carried a 50/50 risk of not responding. Since these results were obtained, we have expanded our screen by an additional 11,000 AIMs/SNPs, and we are still evaluating this data. After this data is evaluated and integrated with our previous data, the next step is to blindly challenge the predictive power of the markers and methods on other ovarian cancer patients that have been treated or are being treated with Taxol/Carboplatin. We intend to extend these trials to other Taxol derivatives and combinations to improve the overall market penetration of our test.
We are identifying the next clinical group to establish a data set of patients whose test information can be reviewed by the FDA either in a filing for a 510K device application or as laboratory testing service provided to physicians. A 510K is an approval from the FDA that allows the sale of a diagnostic test in the United States. FDA's review and approval process normally takes one to two years from the start of the clinical trials to final approval. The length of a clinical trial averages a year or more. The data obtained from the trial will form the basis for a 510K filing. Once trials are completed, the data is compiled, the report is written and finally the 510K is submitted for FDA review and approval. FDA rules regarding pharmacogenomics testing are evolving, and management believes that a 510K filing may not be required in order to perform the service. We are seeking additional guidance from the FDA on this issue.
Initial research results will be the basis for our continued development. We must expand our studies and address other aspects of drug treatment performance that will likely be required before OVANOME(TM) could be used in the clinic to assist chemotherapy decisions.
We are developing a clinical trial for OVANOME(TM). We must validate our research findings further through a clinical trial in order to commercialize OVANOME(TM). The trial will use our test to predict trial participants' responses to the Taxol and Carboplatin drug therapy. Our Chief Medical Officer, Dr. Hector Gomez, will lead the clinical development process and expects to enroll 250 patients in the trial. Currently, we have enrolled 100 new patients into this trial for 2005 and expect to add additional patients later in the year. We are also exploring other clinical relationships to increase our patient sample enrollment. We do not anticipate meeting with the FDA until our trials are completed.
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