Press Release InterMune Announces Plans to Initiate Clinical Programs for ACTIMMUNE in Ovarian Cancer BURLINGAME, Calif.--(BW HealthWire)--Sept. 26, 2000--InterMune Pharmaceuticals (Nasdaq: ITMN - news) announced today that it plans to initiate a clinical trial evaluating the safety and efficacy of ACTIMMUNE® (Interferon gamma-1b) Injection as part of first-line therapy for invasive ovarian cancer. The Company decided to initiate a program in oncology following its independent review of the results of a trial conducted by European researchers that was published in the British Journal of Cancer in March 2000 and was the subject of a review in the July 1, 2000 issue of The Lancet.
The European trial, conducted by G.H. Windbichler at University Hospital in Innsbruck, Austria, 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. This corresponded to median times to progression of 17 and 48 months (p=0.031) and a three-year overall survival of 58% and 74%, respectively.
The authors of the British Journal of Cancer article concluded that ``...the inclusion of interferon gamma in the first-line chemotherapy of ovarian cancer yielded a benefit in prolonging progression-free survival.'' A subsequent editorial by Dr. Jonathan S. Berek, published in the July 1, 2000 issue of The Lancet stated, ``...the addition of interferon gamma to highly effective combination chemotherapy in women with metastatic ovarian epithelial cancer seems to be acceptable in terms of toxicity and is associated with a clear benefit.''
Dr. John W. Park, assistant professor of medicine at the University of California at San Francisco commented, ``Despite advances in the treatment of ovarian cancer, the five-year survival rate for advanced disease remains sub-optimal. If a benefit similar to that shown in this trial can be demonstrated utilizing interferon gamma with platinum- and paclitaxel-based chemotherapy, an important addition to first-line treatment will be made. In addition, the efficacy of interferon gamma in combination with chemotherapy indicated by this study may have implications for other tumor types as well.''
``Based on these exciting results in ovarian cancer, we have decided to expand our ACTIMMUNE® program to include oncology in addition to our focus on serious pulmonary and infectious diseases,'' stated W. Scott Harkonen, M.D., CEO of InterMune. ``We are currently working with investigators regarding trial design for the concomitant use of ACTIMMUNE® in ovarian cancer and will explore the potential for its use in other solid tumor cancers,'' stated Dr. Harkonen.
InterMune Pharmaceuticals, Inc. is a biotechnology company dedicated to the development and commercialization of innovative products for the treatment of serious pulmonary, infectious and congenital diseases. InterMune currently markets ACTIMMUNE® (Interferon gamma-1b) Injection in the United States for the treatment of chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. For more information about InterMune and ACTIMMUNE®, please visit InterMune's web sites at www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com. |