» Exactech's Management Discusses at Canaccord Genuity Global Growth Conference - Conference Call Transcript
» Navidea Biopharmaceuticals' CEO Discusses Q2 2012 Results - Earnings Call Transcript
With us today are Paul McBarron, Executive Vice President, Finance and Chief Operating Officer; and Dr. Judy Chiao, Vice President of Clinical Development and Regulatory affairs. As announced in today's press release, Spiro Rombotis, our President and Chief Executive Officer is on medical leave and will resume his duties in early September, 2012. Paul McBarron, our Executive Vice President of Finance and Chief Operating Officer will perform additional duties during Mr. Rombotis' medical leave including conducting this call.At this time, I would like to turn the call over to Mr. Paul McBarron, our Executive Vice President, Finance and Chief Operating Officer. Paul McBarron Thank you, Corey and good afternoon, everyone. As mentioned by Corey I have been asked to temporarily assume some additional duties of Spiro's during his medical leave. We wish Spiro a rapid recovery and expect that he will resume his duties in early September. It is a pleasure to update you this afternoon on our corporate progress and financial results for the second quarter ended June 30, 2012. First, we are pleased to report that during this last quarter, we continue to open new study sites in the U.S., bringing the total to 35 and enroll patients in the SEAMLESS Phase III trial. We're making steady progress in terms of enrollment towards the second planned periodic safety review to be performed by the independent Data Safety Monitoring Board, or DSMB, in late 2012 or early 2013. As a reminder, SEAMLESS is a randomized Phase III registration-directed trial under a SPA, or Special Protocol Assessment agreement with the FDA, testing our lead product candidate oral sapacitabine capsules as frontline treatment in acute myeloid leukemia, or AML. SEAMLESS is expected to enroll approximately 485 elderly patients, aged 70 years or older, who are not candidates for, or have refused intensive induction therapy. There is a high unmet medical need for the treatment of elderly patients with AML, as the disease is associated with high mortality and poor quality of life. Currently, there is no standard treatment for this group of patients.
In addition to SEAMLESS, we are working with collaborators in investigated sponsored studies to explore sapacitabine in other indications. These studies are where we supply drug product and the cost of the studies are borne by the investigators. These include the Phase II/III Pick a Winner or LI-1 low intensity trial run by the International Cooperative Leukemia Group chaired by Professor Alan Burnett. This is a randomized trial comparing sapacitabine to low-dose cytarabine in patients aged 60 years or older with previously untreated AML or high-risk myelodysplastic syndromes, MDS, who are unfit for intensive chemotherapy. The Phase II part of this study has been completed and over 100 patients have been enrolled. The principal investigator of LI-1 has verbally indicated that based on the observed number of events in the study, the study DSMB is expected to meet later this year to assess overall survival as per protocol.Another investigated sponsored Phase II study, evaluating sapacitabine, in combination with cyclophosphamide and rituximab is being conducted by the Department of Leukemia at the University of Texas and the Anderson Cancer Center. This study is enrolling patients with previously treated chronic lymphocytic leukemia or small lymphocytic leukemia who carry the 11q22-23 deletion. Deletion of chromosome 11q22-23 is associated with the ATM mutation, an important regulator of the HRR DNA repair pathway. In June, we reported new data at the American Society of Clinical Oncology Annual Meeting on ongoing studies conducted by Cyclacel. In the Phase II randomized trial of all sapacitabine capsules in all the patients with MDS after treatment failure of frontline hypomethylating agents such as azacitidine or Victoza and/or decitabine Dacogen were reported median overall survival for all patients at 252 days or approximately 8.4 months. We will initiate regulatory discussions regarding an appropriate registration plan in this setting after dosing schedule MDS is selected. Read the rest of this transcript for free on seekingalpha.com