MGI PHARMA Announces Publication of Phase 3 Data for Saforis(TM) (glutamine) Powder in UpTec(TM) for Oral Suspension in Cancer
Wednesday January 17, 5:00 pm ET
[Somehow, I never felt that these results were impressive. Relatively few patients appear to experience an improvement. Evidently the company is also not considering this a slam-dunk, as they appear to be looking for someone to partner it].
MINNEAPOLIS--(BUSINESS WIRE)--MGI PHARMA, INC. (Nasdaq:MOGN - News), a biopharmaceutical company focused in oncology and acute care, today announced publication of data from a randomized, double-blind, placebo-controlled phase 3 trial of Saforis(TM) (glutamine) Powder in UpTec(TM) for Oral Suspension in the journal Cancer. Results of this study, which were first presented at the American Society of Clinical Oncology (ASCO) 2004 Annual Meeting, indicate that treatment with Saforis significantly reduced the incidence of severe oral mucositis when compared to placebo.
Saforis is an investigational therapy for the treatment and prevention of oral mucositis in patients receiving mucotoxic cancer therapy. Results of this phase 3 study formed the foundation for the Saforis New Drug Application (NDA). MGI PHARMA received an approvable letter for Saforis from the U.S. Food and Drug Administration (FDA) in October 2006. Based on the FDA's request for an additional phase 3 trial, the Company is currently evaluating options to maximize the value of Saforis.
The pivotal phase 3 trial of Saforis was conducted in 326 patients with breast cancer who were receiving anthracycline-based chemotherapy regimens. Patients in this trial were randomized to receive Saforis or placebo during their first chemotherapy cycle. After their first treatment cycle was complete, study participants were then crossed over to receive the alternate treatment during their next cycle of chemotherapy.
The primary endpoint of this trial, defined as a reduction in incidence and severity of oral mucositis, was met. Data from this study indicate that the incidence of World Health Organization (WHO) Grade 2 or higher oral mucositis was significantly reduced in Saforis-treated patients compared to patients who received placebo (38.7 percent versus 49.7 percent; p=0.026). Among those patients that experienced oral mucositis in this study, the incidence of severe oral mucositis (WHO Grade 3 or higher) was significantly lower in the Saforis arm compared with the placebo arm (1.2 percent versus 6.7 percent; p=0.005).
Overall, the data indicated that the safety profile of Saforis was comparable with that of placebo. The most frequently-observed adverse events considered possibly or probably related to the study drug were nausea and dry mouth. No patient experienced a serious adverse event while receiving Saforis. |
