Jennerex and Transgene announce initiation of clinical trial in metastatic colon cancer with intravenous JX-594

Jennerex and Transgene announce initiation of clinical trial in metastatic colon cancer with intravenous JX-594
Tuesday, December 14, 2010

Description :

Jennerex, Inc., an American biotechnology company specializing in the development of innovative targeted oncolytic products in the field of cancer, and Transgene (NYSE Euronext Paris: FR0005175080), an integrated biotechnology company specializing in the development of immunotherapy products, Treatment of patients enrolled in a Phase Ib trial with JX-594 in metastatic colorectal cancer ("mCRC") was initiated. The study will be conducted in South Korea, the country for which the rights to the product have been dismissed from Green Cross Corporation. "The start of this study marks an important milestone in the development of JX-594 in a second major indication in oncology. The number of patients with colorectal cancer

For which existing treatments have failed or are not adapted is high and increasing, and we believe that JX-594, with its unique mechanism of action and the anti-tumor response observed in a pre-clinical model in this type of cancer , Could provide a new therapeutic option for patients, "says Dr. David H. Kirn, CEO of Jennerex, Inc.

"The design of this study is based on our joint experience as well as the encouraging preliminary clinical data obtained with JX-594 in liver cancer," said Philippe Archinard, CEO of Transgene. He adds, "This is an important milestone for the product as we will test the repeated intravenous administration of JX-594."

The escalation study of intravenous doses is conducted at the Samsung Cancer Center in Seoul, South Korea. The study should include 15 patients with metastatic colorectal cancer previously treated with chemotherapy (oxaliplatin and irinotecan) and whose tumors have mutations in the k-ras oncogene and / or are refractory to Erbitux treatment. Patients included in this study will receive intravenous JX-594 injections twice-weekly at one of the three doses of the study to assess safety, tolerance and maximum dose Tolerated product.

About JX-594:

JX-594 is a patented modified oncolytic virus designed to selectively target cancer cells and destroy them. JX-594 is built to attack cancer through three different mechanisms of action: lysis of cancer cells by viral replication, decreased tumor blood supply by targeting and destruction of vascularization, and stimulation of Immune response against cancer cells. Phase I and II trials in multiple cancers to date have shown that JX-594, administered both intra-tumorally and systemically, induces tumor reduction and / or necrosis and is well tolerated by patients . An objective tumor response has been demonstrated in various cancers, including cancers of the liver, colon, kidney, lung and melanoma.

About colorectal cancer:

Colorectal cancer ("CRC") is the second leading cause of cancer death in the United States. The World Health Organization (WHO) counts 639,000 new cases per year worldwide. It is estimated that about one in twenty people in the United States will develop colorectal cancer during their lifetime, with an increased risk depending on age. 90% of CRCs are detected in people over 50 years of age. The exact cause of this cancer is unknown, but there are risk factors such as inflammatory bowel disease, family history, certain genetic syndromes, tobacco, diet and a sedentary lifestyle .

About Jennerex:

Jennerex is a clinical stage biotherapeutic company focused on the development and commercialization of targeted, innovative and breakthrough oncolytic products in the treatment of cancer. The company's most advanced product, JX-594, is currently being tested in two intermediate-phase clinical trials in primary liver cancer patients: an international, randomized, Phase II trial for the Dose-response ratio and a Phase II study in combination with sorafenib.

Published results from previous studies to determine the optimal dose and safety level of JX-594 have shown its ability to selectively target various types of common cancer tumors. JX-594 and other developing products are designed to attack cancer through three differentiated mechanisms of action: lysis of cancer cells through viral replication, reduction of blood supply to tumors by targeting and destruction Vascular and the stimulation of the immune system against cancer cells. Jennerex is based in San Francisco and carries out research and development in Ottawa (Canada) and Pusan ??(South Korea). For more information, visit www.jennerex.com.

About Transgene:

Transgene is a bio-pharmaceutical company that designs and develops immunotherapy products for the treatment of cancers and infectious diseases. The company has four products in Phase II clinical development: TG4010, TG4001 / RG3484, TG4040 and JX-594 / TG6006, and a Phase I clinical development product: TG4023. Transgene has entered into strategic agreements for two of its products:

    A license agreement with Roche for the development of the targeted immunotherapy product TG4001 / RG3484 for the treatment of human papillomavirus (HPV) diseases, and

    A licensing option with Novartis for the development of the targeted immunotherapy product

TG4010 for the treatment of various cancers.

The company recently obtained a license from the American company Jennerex Biotherapeutics, Inc. for the development and commercialization of JX-594 (JX-594 / TG6006), an oncolytic product. Transgene is a vertically integrated company with capabilities for the production of viral vectors.

Disclaimer:

This press release contains information about the markets in which the Company operates and forward-looking statements. Although the Company believes that such information and projections are based on reasonable assumptions, they may be affected by a number of uncertainties and uncertainties, so that actual results could differ materially from those anticipated. For a description of the risks and uncertainties that could affect the Company's results, financial position, performance or achievements and thus result in a change from the forward-looking statements, please refer to the "Risk Factors" section of Reference document filed with the AMF and available on the websites of the AMF (www.amf-france.org) and the Company (www.transgene.com).

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