Tuesday, October 7, 2014
Trading Opportunity - Oxigene (OXGN)
Oxigene announced that will present Phase 2 data for its lead compound Fosbretabulin to treat Ovarian Cancer on November 9th at the International Gynecologic Cancer Society meeting. The company also noted that "additional data are expected to be included in the conference presentation" which tells me that overall survival may be announced at the meeting. The company already reported PFS improvement of 31.5% from the trial but a statistical improvement of overall survival would be a major catalyst for the company as any pivotal trial would likely require overall survival as the primary endpoint. I've provided a copy of the abstract for the meeting below which includes an overall conclusion from the sponsors. Abstract: RANDOMIZED PHASE 2 EVALUATION OF BEVACIZUMAB VERSUS BEVACIZUMAB/FOSBRETABULIN IN RECURRENT OVARIAN, TUBAL OR PERITONEAL CARCINOMA: A GYNECOLOGIC ONCOLOGY GROUP STUDY Aims The Vascular disrupting agent (VDA) fosbretabulin tromethamine selectively targets pre-existing tumor vasculature causing vascular shutdown leading to cell death and necrosis. Anti-angiogenesis agents like bevacizumab, a humanized anti-VEGF monoclonal antibody, might prevent revascularization after/during VDA treatment. Methods Patients with recurrent/persistent epithelial ovarian, tubal, or peritoneal carcinoma; measurable or detectable disease; and < 3 prior regimens were randomized to bevacizumab (15 mg/kg IV q 3weeks) or bevacizumab (15 mg/kg) + fosbretabulin (60 mg/m2) IV every 3 weeks until disease progression or toxicity. Randomization was stratified by disease status (measurable vs. non-measurable), prior bevacizumab, and platinum-free interval. The primary endpoint was progression-free survival (PFS). The study was designed with 80% power at a 10% level of significance to detect a hazard ratio (HR) reduction of 37.5%. Results The study enrolled 107 patients. Median PFS was 4.8 and 7.3 months for bevacizumab and bevacizumab+ fosbretabulin, respectively (HR = 0.685; 90% 2-sided CI=0.47 ~1.00). The proportion responding to bevacizumab was 28.2% (90% CI 16.7 ~ 42.3%) among 39 patients with measurable disease and 35.7% (90% CI 23.5 ~ 49.5%) among 42 patients treated with the combination. Adverse events (> grade 2) were more common in the combination particularly hypertension (35% versus 16%). There was one grade 3 thromboembolic event with the combination. One intestinal perforation in the bevacizumab arm was observed. Conclusion Based on the PFS and tolerability of these two anti-vascular therapies, further evaluation is warranted for this chemotherapy-free regimen. Fosbretabulin in combination with bevacizumab may double the risk of hypertension.