Ovanome Executive Summary: Part 1
EXECUTIVE SUMMARY OF OVANOME
DNAP has achieved a milestone in the field of chemotherapy. On March 19, 2002, DNAPrint and University of Miami doctors presented the successful results of an ongoing pharmacogenomics study to the Society of Gynecological Oncology. The team identified a set of variant human genes that may be used to predict therapeutic outcomes for Paclitaxel (Taxol), one of the most commonly used chemotherapeutic agents for cancer. The product of this discovery is OVANOME, and it?s introduction is expected to boost the first-line paclitaxel response rate in chemo-niave ovarian cancer patients.
OVANOME is a pharmacogenomics product known as a classifier or chemo-predictive test. OVANOME will be used to predict the likelihood of response of ovarian cancer patients to therapy with Paclitaxel (Taxol). Patients that fail the first round of treatment have substantially lower survival statistics. By matching ovarian cancer patients with the drug most appropriate for their genetic constitution, OVANOME has the potential to save lives through pharmacogenomics testing. OVANOME demonstrated excellent sensitivity, specificity and predictive value in preliminary tests.
DNAPrint scientists used an innovative heuristic method with geometrical projection to identify and model proprietary ?eigengenotypes?' or population based vectors of genome information, that serve as features for variable Paclitaxel response. The team found that certain Paclitaxel response ?eigengenotypes? were strongly predictive for first-line chemotherapy response in Ovarian Cancer patients. Data was shown that suggests that by screening patient genomes for these ?eigengenotypes? prior to the commencement of chemotherapy, most non-responders could be flagged and re-directed towards altered doses and/or alternative chemotherapy more appropriate for their genetic constitution.
. The clinical trial for OVANOME will be finished in early 2004 An application for approval to market, if required, will be submitted to the FDA by mid-2004 and approval obtained by early 2005. DNAP has a patent pending for compositions and methods relating to OVANOME. Sales of the OVANOME products to labs in 2005 will result in income of $4 million. This product launch will create a new, emerging US market of over $16 million. OVANOME is forecast to reach a peak-year sales record of $12 million in year three and hold steady for several years as the classifier test of choice in this market niche.
