>>BRISBANE, Calif., Feb. 5 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - news) announced today that it has begun enrolling patients in a Phase III clinical trial of Actimmune® (Interferon gamma-1b) as an adjunctive first-line treatment for ovarian cancer.
This multi-center, randomized trial will evaluate the efficacy and safety of Actimmune in combination with standard chemotherapy (carboplatin plus paclitaxel) in 800 patients recently diagnosed with advanced ovarian cancer. The endpoints of the study are measures of progression-free survival and overall survival.
``There has been no major improvement in the survival rate for ovarian cancer since the advent of platinum and taxane-based chemotherapies in patients with large ovarian masses,'' said David S. Alberts, M.D., Associate Dean for Research, College of Medicine, University of Arizona and the principal investigator of the trial. ``Actimmune represents a potentially powerful adjunct to paclitaxel plus carboplatin regimens for women with previously untreated stage 3 or 4 ovarian cancer.''
Ovarian cancer affects approximately 100,000 women in the United States, with an approximate incidence of 23,000 new cases per year. It is a leading cause of cancer death among women.
``There is an urgent need for new treatments that improve the poor prognosis for women diagnosed with ovarian cancer,'' said W. Scott Harkonen, M.D., President and Chief Executive Officer of InterMune. ``The positive results from a Phase II study give us optimism that Actimmune may be a significant advancement for this disease, which represents a market potential of up to $500 million. We are committed to expanding our oncology product offering by exploring the use of Actimmune in other solid tumors and by adding other anti-cancer products to our portfolio.''
About Actimmune in Ovarian Cancer
The strong rationale for concomitant use of Actimmune in ovarian cancer is based upon the positive outcome of a Phase II European study reported in the British Journal of Cancer in 2000. Results of the study, conducted by G.H. Windbichler, et. al. at University Hospital in Innsbruck, Austria, demonstrated that the inclusion of interferon gamma in the first-line chemotherapy of ovarian cancer yielded a benefit in prolonging progression-free survival. The study was a randomized controlled trial in 148 women who had undergone primary surgery for ovarian cancer, with the control arm receiving cisplatin and cyclophosphamide, and the experimental arm adding interferon gamma to this regimen. Progression-free survival at three years was improved from 38% in the control arm to 51% in the treatment group (p=0.031). This corresponded to median times to progression of 17 and 48 months and a three-year overall survival of 58% and 74%, respectively.<<
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