Billings Clinic Conducts Research Trial for an Investigational Cancer Vaccine for Unresectable Stage III Non-Small Cell Lung Cancer

  START Trial Evaluates Safety and Efficacy of Cancer Vaccine

Billings, MT – Billings Clinic is currently enrolling patients in START, a Phase III clinical study assessing the efficacy and safety of BLP25 Liposome Vaccine (L-BLP25), an investigational lung cancer vaccine designed to treat patients with unresectable, stage III non-small cell lung cancer (NSCLC). START (Stimulating Targeted Antigenic Responses To NSCLC) is designed to evaluate the survival duration of patients receiving the investigational cancer vaccine for unresectable stage III NSCLC whose tumors are stable or responding after chemo-radiation.

“New treatments are urgently needed for patients with advanced non-small cell lung cancer,” said James Burke, MD, Director of Cancer Research at Billings Clinic and a START trial investigator. “Current standard of care typically provides only limited success, with fewer than 15 percent of patients surviving longer than five years. New drugs are essential to help increase survival rates for these patients.”

Cancer vaccines are designed to potentially help the immune system recognize cancer cells, provoke an immune response and stimulate the immune system strongly enough to destroy them. L-BLP25 is the first investigational lung cancer vaccine in unresectable stage III NSCLC to enter Phase III testing. Data from a subset of patients with stage IIIB locoregional disease in the Phase IIb study showed a trend toward a survival increase from 13.3 to 30.6 months and encouraged the initiation of the START study.

“Enrolling patients in the START trial is an important milestone in the development of L-BLP25,” said Bruce Gaumond, Senior Clinical Trial Manager for the U.S. and the Americas, EMD Serono. “We look forward to determining whether this vaccine increases the survival rate for patients with unresectable stage III non-small cell lung cancer.”

Those interested in learning more about the eligibility criteria for the START study or finding a participating center are encouraged to visit www.nsclcstudy.com or www.clinicaltrials.gov.

About BLP25 Liposome Vaccine
BLP25 Liposome Vaccine or L-BLP25 is an investigational cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers, such as those of the lung, breast and colon. L-BLP25 is currently being investigated for the treatment of non-small cell lung cancer (NSCLC) and is the first investigational lung cancer vaccine in unresectable stage III NSCLC to enter Phase III testing.

About START
The Stimulating Targeted Antigenic Responses To NSCLC (START) Phase III clinical study is a clinical trial assessing the efficacy and safety of L-BLP25, an investigational cancer vaccine being developed to treat patients with unresectable stage III NSCLC. Enrollment in the study began in February 2007, with more than 30 countries participating in the trial. More than 1,300 patients at about 250 sites are planned to be enrolled in the START study. The primary endpoint of the START study is overall survival.

START is a multi-center, randomized, double-blind, placebo-controlled study. Patients enrolled will receive either L-BLP25 (1000 mg antigen loading per dose of L-BLP25; weekly injections for eight weeks, maintenance injections at six week intervals thereafter) plus best supportive care (BSC) or a placebo plus BSC. Two-thirds of patients will be assigned to the investigational arm and one-third to the placebo arm.

More information about the START study can be found at www.nsclcstudy.com or www.clinicaltrials.gov.

About Billings Clinic:
Billings Clinic, a leading community organization and the largest employer in Billings, Montana, is a multi-specialty physician group practice and 270-bed hospital. Billings Clinic is a ‘community of physicians’ working together in a collegial manner toward the mission of providing outstanding healthcare, education and research in their region and the nation. Billings Clinic is a not-for-profit organization, governed by the community, with physician leadership at all levels.

About EMD Serono, Inc.
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, with Rebif® (interferon beta-1a), as well as in endocrinology, with Saizen® (somatropin (rDNA origin) for injection), Serostim® (somatropin (rDNA origin) for injection) and Zorbtive™ (somatropin (rDNA origin) for injection). EMD Serono is a leader in fertility treatments, with Gonal-f® (follitropin alpha for injection), Luveris® (lutropin alfa for injection) and Ovidrel® Prefilled Syringe (choriogonadotropin alpha injection). With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono’s US footprint continues to grow, with more than 950 employees around the country and fully integrated commercial, clinical and research operations in the company’s home state of Massachusetts.

For more information, please visit www.emdserono.com.