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Jennerex, Inc. Announces That Its Phase 2 Study of Pexa-Vec in Second-Line Advanced Liver Cancer Did Not Meet Its Primary Endpoint


9/3/2013 2:08:23 PM

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Jennerex Biotherapeutics, Inc. today announced that TRAVERSE, a randomized Phase 2b study of Pexa-Vec in second-line, advanced liver cancer patients had reached the pre-specified number of events for analysis. The study failed to meet its primary endpoint of overall survival for Pexa-Vec plus best supportive care (BSC) compared to BSC. Pexa-Vec was generally well tolerated with an adverse event profile consistent with previous Pexa-Vec studies in patients with advanced liver cancer. Additional analyses will be conducted to further understand these data.

“The rapid progression in this devastating and heterogeneous disease setting has been a longstanding challenge for developing new therapies in liver cancer,” said Tony Reid, M.D., Ph.D., TRAVERSE investigator and professor of clinical medicine, division of hematology-oncology, UC San Diego Moores Cancer Center. “Despite the disappointing outcome on the primary endpoint, the TRAVERSE study was well-conducted and no unexpected safety issues were observed. The field of oncolytic immunotherapy, including Pexa-Vec, continues to hold great promise for physicians and patients.”

“Given the dearth of new treatments for patients with advanced liver cancer, we are disappointed with the results of this study. However, we will continue to analyze TRAVERSE data through the end of the year and look forward to data from Pexa-Vec Phase 2 studies in other liver cancer trials as well as in kidney, colorectal and ovarian cancer,” said Laurent Fischer, M.D., chairman and chief executive officer of Jennerex. “More importantly, we want to thank the patients and their families as well as the investigators for participating in the study. We remain committed to developing new therapies to help patients with cancer.”

Pexa-Vec is also being investigated in Phase 2 studies in colorectal, kidney and ovarian cancer. Jennerex will continue to advance the Pexa-Vec program in these indications while evaluating the Pexa-Vec liver cancer program.

The Jennerex pipeline also includes JX-929, an oncolytic immunotherapy in Phase 1 clinical trials, and a platform for novel oncolytic and antibody-based immunotherapies.

About Jennerex

Jennerex Biotherapeutics, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of groundbreaking oncolytic immunotherapies for patients with life-threatening cancers. The company’s lead product candidate, Pexa-Vec (JX-594), is in mid-stage clinical development for the treatment of advanced primary liver cancer, colorectal cancer, kidney cancer and ovarian cancer, and its next generation product candidate, JX-929, is under investigation for a variety of other solid tumors. Jennerex is headquartered in San Francisco and has related research and development operations in Ottawa, Canada and South Korea. Pexa-Vec is partnered in Europe with Transgene, a member of the Institute Merieux group, in South Korea with Green Cross Corporation and in China with Lee's Pharmaceutical Holdings. For more information about Jennerex, please visit www.jennerex.com.

Contacts

Jennerex Biotherapeutics, Inc.
Katherine Stueland, 415-281-8886
kstueland@jennerex.com

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