Treatment and enrollment in a clinical trial programs with BLP25 liposome vaccine (Stimuvax?, Merck Serono, Darmstadt, Germany/Geneva, Switzerland) in patients with non-small cell lung cancer (NSCLC), which includes the Phase III studies STARTa (Stimulating Targeted Antigenic Responses To NSCLC) and INSPIREb (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response) will restart after approval by the local regulatory authorities and ethics committees.

The vaccine was initially granted fast-track status for NSCLC in September 2004 by the FDA. Merck KGaA obtained the exclusive worldwide licensing rights from Oncothyreon Inc (Seattle, Washington, USA), a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. The BLP25 liposome vaccine is being developed in Europe by Merck Serono. In the United States and Canada, Stimuvax is being developed by EMD Serono, an affiliate of Merck KGaA.

?Merck Serono remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients. We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients,? said Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono.

FDA decision
This announcement follows a decision by the U.S. Food and Drug Administration (FDA) to partially lift the clinical hold it placed on the Investigational New Drug (IND) application for BLP25 liposome vaccine in March 2010 and allow the START trial to be resumed.

?Merck Serono worked constructively with the FDA and other health authorities to address the questions raised on the safety of BLP25 liposome vaccine in patients with NSCLC and, as a result, we can now resume our NSCLC clinical program,? commented Dr. Bernhard Kirschbaum, Head of Global Research and Development of the Merck Serono division. ?We have meanwhile received a number of regulatory approvals to restart in other countries and await approval in the remaining countries.?

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Breast Cancer Study remains on hold
The study that remains on clinical hold by the FDA is the Phase III STRIDEc trial (STimulating immune Response In aDvanced brEast cancer) in advanced breast cancer. Merck Serono will continue to work closely with the health authorities, including the FDA, to decide the next steps for this trial.
The STRIDE study, a randomized, double-blind, controlled, multi-center Phase III trial is designed to determine if the BLP25 liposome vaccine can extend progression free survival in patients treated with hormonal therapy who have inoperable, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study.

Good news for Oncology community and patients
“The resumption of the BLP25 liposome vaccine clinical program is very good news for the oncology community and NSCLC patients. If the START and INSPIRE Phase III trials are successful, BLP25 liposome vaccine could play an important role in the treatment of these currently underserved patients,” said Dr. Frances Shepherd, Director of the Medical Oncology Princess Margaret Hospital in Toronto, Ontario, Canada, and Coordinating Investigator of the START trial.

Merck Serono temporarily suspended its global clinical program for BLP25 liposome vaccine in all recruiting studies worldwide following the clinical hold put in place by the FDA in March 2010. The clinical hold followed a suspected unexpected serious adverse reaction (SUSAR) of encephalitis, observed in a patient enrolled in an exploratory Phase II trial of BLP25 liposome vaccine in patients with multiple myeloma. To ensure the safety of the study subjects, the protocols in the NSCLC trials are being amended to add specific safety measures.

Trial design
The START study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of BLP25 liposome vaccine in subjects suffering from unresectable, stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,300 patients in approximately 30 countries. The primary endpoint of the START study is overall survival (OS).

The INSPIRE study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The design of the INSPIRE study is almost identical to the START study. INSPIRE will enroll approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan. Study participation is expected to last for a minimum of 24 months.

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