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MediGene Announces Cancer-Fighting Virus Shows Promise in Early,Clinical Trial

MARTINSRIED/MUNICH, Germany, July 9, 2007-A virus that has been specifically designed by scientists to be safe to normal tissue but deadly to cancer is showing early promise in a preliminary study, researchers said today at the ESMO Conference Lugano (ECLU), Switzerland.

The virus, called NV1020, is a type of herpes simplex virus modified so that it selectively replicates in virus cells, killing them in the process.

"It doesn't replicate in normal, healthy cells, so our hope is that it will help fight cancers without causing side-effects in the rest of the body," said Dr. Axel Mescheder, VP Clinical Research & Development, from the Munich-based biotech company MediGene. The study is conducted in seven leading US-cancer centers, with Dr. Tony Reid from the University of California in San Diego, CA as Principal Investigator. Dr. Mescheder presented preliminary safety and efficacy results and a case report from this ongoing clinical trial in patients with colorectal cancer metastatic to the liver at the meeting.

Dr. Mescheder's poster presentation described the case of a patient whose cancer had spread to 10 different places around the liver and four in the lungs. He was given the virus treatment in four weekly infusions direct into blood stream, followed by two cycles of approved chemotherapy.

Six months after treatment, scans showed the liver masses had nearly disappeared. "The reduction in the tumor masses was really impressive in this patient," Dr. Mescheder said. "The hepatic masses almost disappeared."

The patient survived for 12 months after treatment.

"In the current study, the scientists are testing the treatment in patients with colorectal cancer that have not responded to chemotherapy and where the cancer has spread to the liver," Dr. Mescheder said. "We are hoping to extend overall survival."

So far, the findings are looking positive. The treatment s eems very tolerable for patients and safe. "The results are really quite encouraging at this early stage," he said.

Almost 40% of patients with colorectal cancer ultimately die from metastatic disease, where the cancer spreads to other parts of the body. Most of the spreading occurs to the liver and 15% of patients have liver metastases at the time of diagnosis.

The latest human results reported today follow testing in the lab and in animals where the virus was shown to be effective at killing colorectal cancer cells and liver cancers.

Notes to Editors

About the European Society for Medical Oncology (ESMO) The European Society for Medical Oncology (ESMO) is the leading European non-profit, professional organization for medical oncology with a focus on promoting multidisciplinary cancer treatment around the world. ESMO unites medical oncologists, oncology specialists, healthcare professionals, caregivers, patients and policy makers in a global alliance committed to eradicating cancer and ensuring equal access to high quality treatment for all patients. Thanks to its state-of-the-art education and training programs, ESMO plays an instrumental role in providing the oncology community with the most up-to-date scientific research and information available. Through its flagship journal, Annals of Oncology, ESMO publishes articles on all aspects of clinical oncology. ESMO is dedicated to educating and supporting oncologists, optimizing patient care, disseminating cancer-specific information to the public, and advocating patient rights. As an authoritative voice in the fight against cancer, ESMO provides both the platform and the consultative expertise to influence national and international organizations as well as European authorities, in order to establish common standards for a multidisciplinary approach to cancer treatment. For more information about ESMO, please visit www.esmo.org.

About ESMO Conference Lugano (ECLU) ECLU 2007 represents the new direction ESMO has given to the scientific and educational meeting previously known as the ESMO Summer Educational Conference (ESEC). It will be held every July under the auspices of the City of Lugano, hometown to the European Society for Medical Oncology (ESMO). Around 1000 young oncologists, senior oncologists and cancer healthcare professionals will attend sessions on the latest developments in multidisciplinary oncology which will cover progress in cancer research and promising new technologies. International cancer specialists will highlight progress on important topics such as pharmacogenomics, molecular diagnostics, molecular-targeted therapies, new frontiers in response evaluation, cancer prevention and state-of-the-art oncology at its finest. Each Conference will also include a session on a specific topic, which in 2007 is the important issue of cancer prevention. The 6th ESMO Patient Seminar, 7 July 2007, will also take place during ECLU. The Patient Seminar provides patients, their families and caregivers the opportunity to interact with international and local oncologists and learn more about the most recent developments and options in cancer treatment. More information about ECLU is available at www.esmo.org/activities/ecluconference/.

For further information please contact

ESMO Communication Department Office tel. +41 (0)91 973 19 07 Office fax +41 (0)91 973 19 93 Mobile +41 76 305 82 68 E-mail: media@esmo.org

ESMO Press Room Tel. +41 91 911 0435

Opening hours

Thursday, 5 July 10:00 - 18:00 Friday, 6 July 8:30 - 19:00 Saturday, 7 July 8:00 - 18:00 Sunday, 8 July 8:00 - 13:00

Abstract No. 47P

Repeated intrahepatic infusion of oncolytic herpes simplex virus nv1020 prior to second-line chemotherapy for patients s uffering from colorectal cancer metastatic to the liver

Matthias Karrasch1, Dan Sze2, Axel Mescheder1, Tony Reid3, 1[Clinical Research & Development, Oncology, Martinsried, GERMANY], 2[Stanford University, Dep. of Radiology, Palo Alto, CA], 3[University of California San Diego, Oncology, San Diego, CA, USA] Introduction: Treatment options for patients with colorectal cancer (CRC) metastatic to the liver who fail first-line chemotherapy are sparse. Genetically-engineered oncolytic viruses can selectively replicate, spread in situ, and lyse malignant cells while sparing normal tissue, thus maybe advantageous over chemotherapy. Previous clinical studies have shown that single doses of the oncolytic herpes simplex virus NV1020 administered regionally are well tolerated and suggest that it may induce tumor regression. Interim data from a Phase I/II trial testing NV1020 on hepatic metastases from CRC are encouraging. Methods: NV1020 was administered as 4 weekly intra-arterial infusions at up to 1x10e8 pfu to patients who had failed first-line therapy. Viral therapy was followed by two cycles of second-line chemotherapy using FDA-approved agents for treatment of colorectal cancer. Results: Dose escalation to 1x10e8 pfu NV1020 was performed without dose-limiting toxicities, and maximum tolerated dose was not reached. Several patients demonstrated regression of tumors. At the highest dose level (1x10e8 pfu), a patient with refractory disease demonstrated a destinct response. At study entry, the patient had 10 measurable hepatic masses and 4 measurable pulmonary nodules. The hepatic tumors showed an initial enlargement after NV1020 infusion, followed by regression. 6 months post treatment, the PET scan demonstrated no measurable FDG uptake within the lungs and near complete resolution of the liver masses. Photopenic areas were observed in the liver consistent with necrosis. The patient survived for 12 months. Conclusions: In this Phase I/II trial, dose escalation w ith NV1020 was completed without significant toxicities. Several clinical responses were observed. Here, we report of a patient with 12 months overall survival after progressive disease following 1st line chemotherapy with FOLFOX. At stage 2 of this study additional patients are being enrolled into the expansion cohort at the highest dose to further investigate potential efficacy of NV1020 followed by chemotherapy for metastatic CRC Keywords: colorectal cancer, advanced/metastatic; liver metastases


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