-- Study Details Use of Ethyol in Radiation Setting --
Mountain View, CA., and Gaithersburg, MD, October 4, 2000 -- ALZA Corporation (NYSE: AZA) and MedImmune, Inc (NASDAQ: MEDI) today announced that the American Society of Clinical Oncology published a pivotal Phase III study evaluating the use of Ethyol® (amifostine) in the care of head and neck cancer patients receiving radiation therapy. The study appears in the Journal of Clinical Oncology , (Vol. 18, No. 19, October, 2000).
The article, “Phase III Randomized Trial of Amifostine as a Radioprotector in Head and Neck Cancer,” details the expanded use of Ethyol in an important radiation setting, specifically, the reduction of moderate-to-severe xerostomia (dry mouth) which was approved by the U.S. Food and Drug Administration in June 1999.
“The results of this study may be particularly useful to radiation oncologists in designing treatment approaches for the care of patients with head and neck cancer, a majority of whom will receive radiation treatment,” said David Brizel, M.D., associate professor of Radiation Oncology at Duke University Medical Center and one of the principal investigators in the study. “Ethyol has been demonstrated to help limit the degree of xerostomia that many patients suffer as a result of head and neck cancer. In this study, the reduced incidence of xerostomia was evaluated according to accepted medical criteria as well as according to patients, who provided self-assessments of their symptoms.”
Xerostomia, a chronic dry mouth condition, may be a severe and often irreversible side effect of radiation therapy caused by damage to the salivary glands. Patients who experience xerostomia may have difficulty chewing, swallowing or speaking.
Study Highlights Safety and Efficacy of Amifostine to Radiation Oncology Community “The publication of this study is a pivotal addition to the growing body of clinical evidence available to radiation oncologists on the use of Ethyol,” said Edward Schnipper, M.D., vice president, clinical development, ALZA Corporation. “We believe this study and the ongoing efforts of our specialty oncology sales forces will continue to solidify the use of Ethyol in radiation oncology.”
In the United States, Ethyol is marketed by ALZA Corporation and co-promoted by MedImmune Oncology, Inc.
Data from this Phase III, open-label, prospective multi-center randomized trial, which involved more than 300 patients with head and neck cancer demonstrated that approximately one month following treatment, 78 percent of patients given radiation alone experienced moderate to severe xerostomia, compared with 51 percent of patients treated with amifostine prior to radiation. This represented a 35 percent reduction in the incidence of moderate to severe xerostomia with the use of Ethyol (p<0.0001). One year after the completion of radiotherapy, 72 percent of the patients receiving Ethyol could produce a clinically relevant volume of saliva (>0.1 cc), compared with only 49 percent of patients who did not receive Ethyol. Furthermore, nine to 12 months after radiation therapy, 57 percent of the patients in this trial who had been treated with radiation alone were still experiencing moderate to severe xerostomia, as compared to 35 percent of the patients in the Ethyol arm.
In the study, patients evaluated their symptoms through a questionnaire given during and after treatment. The questions addressed issues including impairment of speaking, taste, swallowing, need for oral comfort aids and sensation of mouth dryness. In the clinical study, improvements in these subjective measurements of oral dryness were considered to be supportive of the efficacy of Ethyol.
Treatment-related side effects of Ethyol reported by patients receiving amifostine plus radiation in the Phase III study were nausea and vomiting, which were sometimes severe, hypotension, fever, allergic-type skin reactions, dizziness/lightheadedness, fatigue/lethargy, rigors/chills, sneezing, sleepiness/somnolence, and flushing. Of the 26 patients who discontinued Ethyol due to side effects, all but one continued radiation treatment following discontinuation of Ethyol. Ethyol is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation therapy for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands, and should not be administered in patients receiving definitive radiation therapy except in the context of a clinical trial.
ALZA Corporation, headquartered in Mountain View, Calif., is a research-based pharmaceutical company with leading drug delivery technologies. The company applies its delivery technologies to develop pharmaceutical products with enhanced therapeutic value for its own portfolio and for many of the world's leading pharmaceutical companies. ALZA's sales and marketing efforts are focused on urology, oncology and central nervous system products.
MedImmune, Inc. is a fully integrated biotechnology company focused on developing and marketing products that address medical needs in areas such as infectious disease, immune regulation and cancer. Headquartered in Gaithersburg, Maryland, MedImmune has manufacturing facilities in Frederick, Maryland and Nijmegen, the Netherlands, and an oncology subsidiary in West Conshohocken, Pennsylvania. For more information on MedImmune, visit the company's website at www.medimmune.com.
This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the company's filings with the U.S. Securities and Exchange Commission. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.