Advertisement
The poster presentation, entitled "5,10 methylenetetrahydrofolic acid with5-fluorouracil as treatment for advanced breast cancer in patients who failedprior treatment with anthracyclines and taxanes: A phase 2 study," waspresented by Dr. Joachim P.H. Schupp, Vice President of Medical Affairs on June2, 2008.
Advertisement
Historically, capecitabine (Xeloda(R)), a widely-used treatment foradvanced breast cancer, has demonstrated response rates between 14% and 26%when studied as monotherapy in patients with advanced breast cancer who failedprior treatment with anthracyclines and taxanes. In this well-defined studypopulation, two recently published, Phase 3 clinical trials, where capecitabinewas the approved therapy, demonstrated response rates of 14% for capecitabinealone compared with 35% for capecitabine in combination with ixabepilone or 22%for capecitabine in combination with lapatinib.
"This CoFactor data is encouraging to us as it surpasses the most recentlyreported response rates with capecitabine in pretreated advanced breast cancerpatients. CoFactor plus 5-FU could be an effective and safe treatment optionfor patients with pretreated advanced breast cancer with the potential forfurther improvements to be shown with appropriate combination therapies,"stated Evan M. Levine, Chief Executive Officer and President of ADVENTRX. "Welook forward to evaluating all of the available data from the rest of ourCoFactor program, and following analysis of these data we should have greaterinsight into the value of continuing to develop CoFactor," added Mr. Levine.
The most common adverse events in this study were expected and included thefollowing, which reflects all grades: asthenia (52%), nausea (33%), diarrhea(29%), vomiting (26%), anorexia (23%), dyspnea (23%), and neutropenia (23%).Five patients reported 12 serious adverse events (pneumonia, abdominal pain,diarrhea (2), general physical health deterioration (3), pancytopenia, breastpain, dyspnea, asthenia, and hypersensitivity). Patients in this study willcontinue to be followed for other efficacy and safety parameters.
The Company's Phase 2 clinical trial was a single arm, multicenter studydesigned to evaluate the safety and efficacy of treatment with CoFactor/5-FUutilizing a bolus administration in patients with advanced breast cancer whohave failed anthracycline and taxane chemotherapies with clearly definedcriteria. The primary endpoint for the study is assessing objective responserate as defined by Response Evaluation Criteria in Solid Tumors (RECIST)criteria. RECIST criteria is a series of formalized rules for the measurementof tumor target lesions and involves techniques which measure tumor responseusing X-rays, CT and MRI scans. Objective response rate is measured bycombining the number of complete responses and partial responses. According toRECIST criteria, a complete response (CR) indicates the disappearance of alltarget lesions and a partial response (PR) indicates a 30% decrease in the sumof the longest diameter of target l
