Monday, Apr 4, 1994
South San Francisco, Calif. -- April 4, 1994 --Genentech, Inc. (NYSE: GNE) announced today topline results of the Pulmozyme® (domase alfa) Phase II clinical trial for the treatment of acute exacerbations of chronic bronchitis (CB). The results of the multi-center, 244-patient, double-blinded, placebo-controlled study indicate Pulmozyme significantly reduced mortality of patients hospitalized for treatment of acute exacerbations of CB and also significantly decreased the number of patient rehospitalizations and relapses. Time to resolution and spirometric improvement did not reach statistical significance.
Genentech conducted the Phase II trial as part of a full-scale development effort in acute exacerbations of CB. The results of the study should not be considered conclusive. A larger, more definitive Phase III clinical trial is needed to confirm the magnitude of the results and is currently planned to begin in the U.S., Europe and Canada by the Fall of 1994.
The study found no major side effects with aerosolized rhDNase, and showed a statistically significant reduction in rehospitalization as well as respiratory relapse. Mortality, which was largely respiratory related, was significantly reduced. The decrease in mortality was sustained over an additional four month followup. The treatment arms were balanced in all parameters related to disease severity.
Dr. Antonio Anzueto, Assistant Professor of Medicine at the University of Texas Health Science Center, San Antonio, will present the results of the Phase II trial at the annual scientific session of the American Federation of Clinical Research (AFCR) on May 2nd in Baltimore. The abstract is being distributed tomorrow by AFCR in its listing of all abstracts to be presented at the meeting. The full Phase 11 study results will be submitted to a leading peer-reviewed medical journal for publication.
CB is a lung disorder resulting from a number of causes, primarily smoking. Inflammation and obstruction of the airways associated with CB increases the amount of respiratory secretions resulting in recurrent infections. The accumulation of infected secretions is a debilitating and potentially fatal complication of this disease. Acute exacerbations requiring hospitalization are a major cause of morbidity in patients with CB. There are approximately 600,000 hospitalizations each year, according to HCIA, a U.S. hospital database.
According to the abstract, "This early, limited clinical trial suggests an important therapeutic role for rhDNase in the management of acute exacerbations of this common chronic obstructive lung disease patient group."
Pulmozyme is currently indicated for the treatment of cystic fibrosis (CF). Genentech received a license to market the product for cystic fibrosis from regulatory authorities in the United States and Canada on December 30, 1993. Pulmozyme has also been approved for marketing as a CF treatment in Austria, New Zealand, Sweden, the United Kingdom and Argentina. Genentech markets Pulmozyme in Europe via a joint development and marketing agreement with F. Hoffmann-La Roche Ltd.
Genentech, Inc. is a leading, international biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchanges under the symbol GNE.
# # #