BURLINGAME, Calif., April 5 /PRNewswire/ -- InterMune (Nasdaq: ITMN - news) announced today that it has completed enrollment in its first human trial with ACTIMMUNE® for the treatment of systemic fungal disease. The Phase II trial has enrolled 79 patients with cryptococcal meningitis, a life-threatening fungal infection, to evaluate the safety and efficacy of ACTIMMUNE® in combination with amphotericin B. Results are expected in the fourth quarter of 2001.
Cryptococcal meningitis is a difficult-to-treat, life-threatening infection. Only 60% of patients respond to standard treatment, which is usually amphotericin B. A study published in the Journal of Antimicrobial Chemotherapy in September 2000 showed that in mouse models of cryptococcal fungal infection, combination therapy using ACTIMMUNE® and amphotericin B cured 78% of the infected mice, while amphotericin B alone cured only 10%.
``We are very excited to complete enrollment in this trial, and look forward to the results of this first study utilizing this promising new combination,'' said W. Scott Harkonen, M.D., President and CEO of InterMune. ``This therapy looks particularly exciting on the heels of our acquisition of Amphotec® and our recent international strategic partnership with Boehringher Ingelheim, which includes the global development of ACTIMMUNE® for life-threatening fungal diseases.''
InterMune also announced the initiation of a clinical program for ACTIMMUNE® in Japan, where it maintains infectious disease rights. ACTIMMUNE® is not yet approved in Japan, and the Company recently initiated a Phase I clinical trial there evaluating the safety of inhaled ACTIMMUNE® in healthy volunteers. InterMune plans to develop the product in Japan for life-threatening infectious diseases, as well as chronic granulomatous disease (CGD) and severe, malignant osteopetrosis, two indications for which ACTIMMUNE® is already approved in the United States.
``The initiation of clinical programs for ACTIMMUNE® in Japan is an important addition to InterMune's growing global presence,'' said Dr. Harkonen. ``In Japan, the incidence of tuberculosis is four times that of the United States, resulting in 43,000 new cases of tuberculosis each year and 2,000 cases of multidrug-resistant tuberculosis each year. This has led the Japanese Ministry of Health to declare tuberculosis a national emergency.'' InterMune is currently conducting a U.S. Phase III clinical trial with ACTIMMUNE® for the treatment of multidrug-resistant tuberculosis (MDR TB).
InterMune also announced that it plans to develop ACTIMMUNE® for the treatment of liver fibrosis (cirrhosis) associated with hepatitis C infection. There are approximately four million people in the United States with hepatitis C, and standard therapy is frequently ineffective. In a clinical study comparing the therapeutic efficacy of interferon gamma and interferon alpha in patients with hepatitis C, the results showed a strong trend towards decreased fibrosis in the patients receiving interferon gamma, compared to no change in patients receiving interferon alpha. In addition, several pre-clinical studies have demonstrated that ACTIMMUNE® may prevent and even reverse the fibrosis that forms in the liver as a result of infections or liver toxins. The Company plans to initiate a Phase II clinical trial in the fourth quarter of 2001.
``This is a novel approach to the treatment of liver fibrosis in patients with hepatitis C,'' said James Pennington, M.D., Executive Vice President of Medical and Scientific Affairs for InterMune. ``Standard treatments for hepatitis C address only the virus and not the fibrosis. We believe that ACTIMMUNE®'s demonstrated anti-fibrotic activity may reduce the amount of fibrosis in the liver and could work synergistically with standard treatments that address only the viral infection.''... |
