COLUMBUS, Ohio — Battelle, one of the world's leading technology development and commercialization organizations, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the initiation of Phase I clinical trials on its inhalation chemotherapy treatment for lung cancer and tumors which have metastasized to the lung.

"We are very excited that FDA has cleared us for Phase I clinical trials," said Dennis Cearlock, President and CEO of Battelle Pulmonary Therapeutics, a for-profit subsidiary of Battelle Memorial Institute. "We believe we have a promising new method to treat lung cancer by delivering the medication directly to the lungs by inhalation."

"We're also working on using inhalation to treat a variety of other diseases-both lung and systemic diseases," added Cearlock. "But we're especially excited about this technology as a lung cancer treatment, because, among all cancers, lung cancer is the number-one killer of both men and women."

Key to Battelle's approach is a new device and procedure, which allows controlled delivery of the drug to the lung without contaminating the environment and exposing the therapists to toxic chemotherapy drugs.

Phase I clinical trials will involve low doses of doxorubicin in patients who have cancer in their lungs which is not treatable by conventional means. The first trial will be conducted at Memorial Sloan-Kettering Cancer Center in New York with additional trials expected to begin at other leading cancer centers later this year. The National Cancer Institute is collaborating with Battelle on this program.

"This technology represents a potential breakthrough therapy that addresses an urgent, unmet need-lung cancer and metastases to the lung from other cancers, such as breast cancer," added Cearlock.

"The most effective therapy is surgery and/or radiotherapy; however, unless the tumors are detected at an early stage and are discrete lesions that can be removed surgically or irradiated, the patient is likely to die within a few years. Traditional chemotherapy given intravenously has resulted in relatively small increases in survival and is not effective for the long term."

In the United States, 171,500 people are diagnosed with lung cancer every year. Of this total, approximately 60 percent die within one year and 86 percent within five years. In addition, there are more than 100,000 patients who have tumors which have metastasized to the lung from other organs.

Phase I clinical trial work is targeted for completion in late 2000.

Battelle Pulmonary Therapeutics (BPT) is a for-profit subsidiary of Battelle Memorial Institute. BPT focuses on developing pulmonary drug products and medical devices that can treat respiratory and systemic diseases. Battelle focuses on product development, technology development, technology commercialization, and laboratory management. Headquartered in Columbus, Ohio, Battelle has annual revenues of nearly $1 billion and more than 60 locations throughout the world.

For more information contact Media Relations Manager Katy Delaney at (614) 424-5544, or e-mail delaneyk@battelle.org.