Press Releases
Jennerex Names Ursula Fritsch, PharmD, as Vice President, Regulatory Affairs
San Francisco, California, January 19, 2011 — Jennerex, Inc. (San Francisco), a clinical-stage biotherapeutics company focused on the development of first-in-class, targeted oncolytic products for cancer, today announced the appointment of Ursula Fritsch to the newly-created position of vice president, regulatory affairs. Dr. Fritsch will be responsible for developing global regulatory strategies and managing all aspects of regulatory affairs for all Jennerex pipeline product candidates.
"We welcome Dr. Fritsch to Jennerex at this pivotal time in the company's growth, as we enter late-stage clinical development of JX-594 in liver cancer," said David H. Kirn, M.D., president and chief executive officer of Jennerex. "As we make continued progress along the regulatory pathway in the United States and internationally for JX-594 and other compounds, Ursula's broad experience and proven track record in managing the regulatory processes and filings for a wide variety of products and disease indications make her an ideal fit for Jennerex."
Dr. Fritsch brings more than 20 years of biopharmaceutical regulatory affairs experience to Jennerex. Prior to Jennerex, she served as vice president of global regulatory affairs and compliance for Anthera Pharmaceuticals, where she was responsible for the strategy and implementation of all U.S. and international regulatory activities for the company's late-stage product portfolio. Previously‚ Dr. Fritsch served as senior director of regulatory affairs at Peninsula Pharmaceuticals‚ where she oversaw the late-stage regulatory strategy and operations for two key compounds, spearheading all regulatory filings including Investigational New Drug (IND) applications‚ fast track designation and orphan drug applications. Prior to Peninsula, she served as the head of regulatory affairs at Onyx Pharmaceuticals, providing global leadership for the development of Nexavar® and its oncolytic virus therapy programs. In addition‚ Dr. Fritsch held various management positions and oversaw several New Drug Application (NDA) approvals at Genentech‚ Inc. and Oclassen Pharmaceuticals. In addition to her tenure in biotechnology companies, Dr. Fritsch also acted as president of East Bay Bio‚ Inc.‚ a regulatory consulting company focusing on strategic drug development and submission work in all phases of development from pre–IND to NDA filing and post approval/marketing issues. Dr. Fritsch received her Doctor of Pharmacy degree from Creighton University and her BA from the University of Nebraska.
About Jennerex
Jennerex, Inc. is a clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic products for cancer. The Company's lead product JX-594 is currently in two Phase 2 clinical trials in patients with primary liver cancer—an international, randomized, Phase 2 clinical trial, and a Phase 2 study of JX-594 in combination with sorafenib. Published studies designed to establish optimal dose levels and the safety profile of JX-594 have shown its ability to selectively target and cause destruction of a variety of common cancer types. JX-594 and other product candidates under development are designed to attack cancer tumors through three diverse mechanisms of action: the lysis of cancer cells through viral replication, the ablation of the blood supply to tumors through vascular targeting and destruction and the stimulation of the body's immune response against the cancer. Jennerex is headquartered in San Francisco and has related research and development operations in Ottawa, Canada and Pusan, South Korea. For more information about Jennerex, please visit www.jennerex.com.
Cautionary note for Transgene regarding forward-looking statements
This press release contains forward-looking statements referring to the joint clinical testing and development and commercial potential of JX-594. Clinical testing and successful product development and commercialization depend on a variety of factors, including the timing and success of future patient enrolment, the risk of unanticipated adverse patient reactions, regulatory approval and the level of demand for the product by the medical community. Results from future studies with more data may show less favorable outcomes than prior studies, and there is no certainty that product candidates will ever demonstrate adequate therapeutic efficacy or achieve regulatory approval or commercial success. In addition, forward-looking statements regarding product development, testing and marketing costs are by the nature subject to uncertainties as a result of unforeseen difficulties and expenses which may arise, and future product development costs may exceed current expectations. For further information on the risks and uncertainties involved in the testing and development of Transgene's product candidates, see Transgene's Document de Référence on file with the French Autorité des marchés financiers on its website at http://www.amf-france.org and Transgene's website at www.transgene.fr.
