Rush University Medical Center Studies New Agent To Treat Lung Cancer Patients; First Clinical Trial of Investigational Therapy to Treat BAC.

CHICAGO -- Enrollment is under way for a new clinical trial to study the effectiveness of an investigational agent in patients with bronchioloalveolar carcinoma (BAC), a subtype of non-small cell lung cancer. The PEAK trial is a multicenter, open-label, phase II trial that will be led at Rush University Medical Center by Dr. Philip D. Bonomi, a leading oncology researcher who has participated in several studies of treatments for non-small cell lung cancer.

The primary objective of the PEAK trial is to determine the efficacy of the investigational agent in terms of tumor response rate in patients with advanced BAC who have progressed after treatment with up to two previous rounds of chemotherapy, one of which must be Iressa(R) or Tarceva(TM)(1).

Approximately 30,000 patients in the United States are living with BAC. These patients represent approximately 20 percent of all non-small cell lung patients and typically respond poorly to chemotherapy treatments used for treating other forms of non-small cell lung cancer(2). Data suggest that the incidence of BAC is increasing, notably in younger, non-smoking women. Despite reports of prolonged survival, BAC remains incurable with the vast majority of patients dying of respiratory failure or pneumonia within five years of diagnosis.

"While some patients with BAC are able to respond to therapies currently on the market, there is a subset of patients who try and fail on several rounds of chemotherapy, which can be a devastating process," said Dr. Bonomi. "This trial provides us with an additional opportunity to treat these patients while investigating the overall response rate for patients treated with this therapy."

The PEAK trial will enroll up to 150 male and female patients at 40 centers in the United States and 10 sites in Europe and Canada. Patients will receive the investigational drug by injection twice per week for two weeks followed by a week of rest. These 3-week treatment cycles will be repeated as long as the patients' doctor determines the injections may continue. The length of participation in the study will depend upon a patients' response to the investigational medication. The overall duration of this research study is expected to be a maximum of 26 months.

Patients interested in more information on the PEAK trial being conducted at Rush University Medical Center should call [phone]. For general information on the trial, patients and physicians can call 1-866-835-2233.

Rush University Medical Center is an academic medical center that encompasses the 600-(staffed) bed hospital (including Rush Children's Hospital), the Johnston R. Bowman Health Center and Rush University. Rush University, with more than 1,270 students, is home to one of the first medical schools in the Midwest, and one of the nation's top-ranked nursing colleges. The University also offers graduate programs in allied health and the basic sciences. Rush is noted for bringing together clinical care and research to address major health problems, including arthritis and orthopedic disorders, cancer, heart disease, mental illness, neurological disorders and diseases associated with aging.

(1) Iressa(R) and Tarceva(TM) are registered trademarks of AstraZeneca and OSI Pharmaceuticals, respectively.

(2) Barsky SH, Cameron R, Osann KE, et al: Rising incidence of bronchiolalveolar lung carcinoma and its unique clinicopathologic features. Cancer 73:1163-1170, 1994) (Furak J, Trogan Ik, Szoke T, et al: Bronchioloalveolar lung cancer: Occurrence, surgical treatment and survival. Eur J Cardiothoracic Surg 23:818-823,2003).