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CHILDREN'S HOSPITAL OF WISCONSIN AND MEDICAL COLLEGE OF WISCONSIN LAUNCH CLINICAL TRIAL FOR TREATMENT OF CHILDHOOD BRAIN TUMORS

April 4, 2013

Children and adolescents with recurrent or progressive brain tumors will have an opportunity to participate in a new Phase 1 clinical trial conducted by Children's Hospital of Wisconsin and the Medical College of Wisconsin investigating the safety of a novel brain cancer treatment.

The survival of pediatric patients with recurrent brain tumors is measured in months, with few long-term survivors. New therapies for children with brain tumors are needed. Photodynamic therapy (PDT) is a promising treatment for patients with recurrent, malignant brain tumors. PDT is a two-step cancer treatment process. A photosensitizing drug called PHOTOFRIN® is injected into the blood steam of patients where it accumulates in cancer cells in the brain. Immediately after surgical removal of the tumor, PHOTOFRIN® is activated with laser light killing any remaining cancer cells in the nearby brain. A previous clinical trial using PDT for the treatment of adults with recurrent, malignant brain tumors demonstrated long-term survival in 40%-50% of patients i.

Harry T. Whelan, MD, the Bleser Professor of Neurology and Pediatrics and Hyperbaric Medicine at Children's Hospital of Wisconsin, and Professor of Neurology at the Medical College of Wisconsin, is the lead investigator for the study. "We believe the demonstrated effectiveness and safety of PDT in adults warrants application in pediatric patients with recurrent/refractory, high-grade brain tumors. Children's Hospital of Wisconsin (CHW) is one of the few centers in the country with experience utilizing PDT technology for the treatment of brain tumors ii. As a result we are uniquely poised to apply PDT treatment in pediatric patients." Dr. Whelan's clinical research team has partnered with Pinnacle Biologics, Inc. who will provide PHOTOFRIN®, the laser and additional resources and expertise to make the study possible.

This is a Phase 1 limited dose-escalation study of PHOTOFRIN® in pediatric and adolescent patients with recurrent or refractory, malignant brain tumors. The primary objective of this study is to identify a maximum tolerated dose (MTD) and to characterize the side-effect profile of PHOTOFRIN® in children with recurrent brain tumors.

Eligible patients will have injection of PHOTOFRIN® followed by surgical resection of the tumor 24 hours later. Activation of PHOTOFRIN® in the tumor bed will be performed using an intra-operative laser. Patients will receive standard post-operative care and will be closely monitored at CHW during the first month for side effects associated with PHOTOFRIN® activation. Patients will then return to their referring facilities and receive any additional therapy for treatment of their cancer. Long-term study monitoring will be performed through referring facilities.

More information about the clinical trial can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01682746

About Photodynamic therapy (PDT) and PHOTOFRIN®
Photodynamic therapy with PHOTOFRIN® is a two-stage process requiring administration of both drug and light. The first stage of PDT is the intravenous injection of PHOTOFRIN. The second stage of therapy uses illumination with non-burning laser light 24–50 hours following injection with PHOTOFRIN®. When injected, PHOTOFRIN® is attracted to certain tissues, especially cancer cells. Tumor destruction results from biochemical reactions, not heat. Tumor selectivity occurs through a combination of preferential retention of PHOTOFRIN® by the tumor and selective delivery of light to the tumor site. PHOTOFRIN® is FDA approved for the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The product is available in the USA, several major European countries, Japan, several Latin American and Southeast Asian markets. PHOTOFRIN® also is approved for high-grade dysplasia (HGD) in Barrett's esophagus (BE) in North America. It also has Orphan Drug Designation (ODD) for cholangio-carcinoma and as adjuvant therapy to surgery for the treatment of malignant pleural mesothelioma. For additional information about PHOTOFRIN®, please see full prescribing information available at www.photofrin.com.

About Pinnacle
Pinnacle Biologics Inc. is a privately held bio-pharmaceutical company specializing in revitalizing healthcare therapies to expand therapeutic potential and maximize favorable patient outcomes. The company is headquartered in Bannockburn, Illinois. Its European subsidiary, Pinnacle Biologics BV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

About the Medical College of Wisconsin
The Medical College of Wisconsin is the state's only private medical school and health sciences graduate school. Founded in 1893, it is dedicated to leadership and excellence in education, patient care, research and service. More than 1,200 students are enrolled in the Medical College's medical school and graduate school programs. A major national research center, it is the largest research institution in the Milwaukee metro area and second largest in Wisconsin. In FY 2011 – 12, faculty received more than $166 million in external support for research, teaching, training and related purposes, of which more than $152 million is for research. This total includes highly competitive research and training awards from the National Institutes of Health (NIH). Annually, College faculty direct or collaborate on more than 2,000 research studies, including clinical trials. Additionally, more than 1,350 physicians provide care in virtually every specialty of medicine for more than 425,000 patients annually.

About Children's Hospital of Wisconsin
Children's Hospital of Wisconsin is the region's only independent health care system dedicated solely to the health and well-being of children. The hospital, with locations in Milwaukee and Neenah, Wis., is recognized as one of the leading pediatric health care centers in the United States and is ranked No. 4 in the nation by Parents magazine. Children's Hospital provides primary care, specialty care, urgent care, emergency care, community health services, foster and adoption services, child and family counseling, child advocacy services and family resource centers. In 2011, Children's Hospital invested more than $100 million in the community to improve the health status of children through medical care, advocacy, education and pediatric medical research. Children's Hospital achieves its mission in part through donations from individuals, corporations and foundations and is proud to be a member of Children's Miracle Network Hospitals. For more information, visit the website at chw.org.

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