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Valneva Announces Publication in The Lancet of Complete Phase 1 Data for its Single-Shot Chikungunya Vaccine CandidateSaint-Herblain (France), June 2, 2020 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, announced today the publication of full data from the Phase 1 clinical trial of its chikungunya vaccine candidate, VLA1553, in the peer-reviewed medical journal The Lancet Infectious Diseases. The Lancet paper provides a detailed analysis of final Phase 1 results and supports the continued clinical development of VLA1553. Wolfgang Bender, Ph.D., M.D., Chief Medical Officer of Valneva, commented, “We reported excellent Phase 1 results1 for our single-shot chikungunya vaccine and we’re pleased that these important results are now fully available to the broader infectious disease community. Millions of people have been affected by chikungunya and our objective is to help address this ongoing public health crisis as soon as we can." Valneva has previously reported the successful outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA)2 in February 2020 and is now preparing to initiate Phase 3 clinical studies in the U.S. later this year. About Chikungunya About Valneva’s vaccine candidate VLA1553 About Valneva SE
Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of their in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 3 WHO, PAHO 4 PAHO/WHO data: Number of reported cases of Chikungunya Fever in the Americas – EW 51 (December 22, 2017) 5 Cardona-Ospina et al. 2015, Trans R Soc Trip Med Hyg 109:793-802. 6 Valneva Awarded FDA Fast Track Designation for Chikungunya vaccine candidate 7 Company estimate supported by an independent market study 8 Hallengärd et al. 2013, J. Virology 88:2858-2866.
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