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NIAID Sponsors ILiAD Biotechnologies BPZE1 Pertussis Vaccine Phase 2a Clinical Study at Vanderbilt UniversityWESTON, Fla. and NASHVILLE, Tenn., May 15, 2018 (GLOBE NEWSWIRE) -- ILiAD Biotechnologies, LLC (ILiAD) and Vanderbilt University Medical Center today announced filing of an Investigational New Drug (IND) application by the National Institute for Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) to study the next generation pertussis vaccine BPZE1 at the Vanderbilt Vaccine Research Program. Earlier this year, NIAID and ILiAD signed a clinical trial agreement calling for NIAID to sponsor the BPZE1 Phase 2a clinical trial and for ILiAD to supply BPZE1 vaccine study product. The NIAID Division of Microbiology and Infectious Diseases (DMID) will sponsor the study through the Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU), one of nine VTEUs in the United States. BPZE1 is the most advanced next generation pertussis vaccine, designed to overcome deficiencies of current vaccines, including poor durability and failure to prevent nasopharyngeal Bordetella pertussis infections that lead to transmission to vulnerable infants. The Phase 2a clinical trial will compare a placebo control to two different doses (107 and 109 CFU) of a single intranasal BPZE1 administration in 50 healthy adults. The purpose of the study is to demonstrate preliminary safety of ILiAD’s pertussis vaccine in its lyophilized commercial formulation and to choose the optimal dose for a planned ILiAD-sponsored multicenter Phase 2b clinical study that will compare the candidate BPZE1 vaccine to Boostrix™, an FDA-licensed intramuscular acellular pertussis vaccine. The phase 2b study will enroll up to 300 healthy adult volunteers. "We eagerly anticipate the initiation of BPZE1 U.S. Phase 2 studies and are grateful for the study support from NIAID and the study leadership of Kathryn Edwards and Buddy Creech at Vanderbilt,” said Dr. Keith Rubin, Chief Executive Officer of ILiAD. Dr. Creech, Principal Investigator for the Phase 2a study stated, “The BPZE1 intranasal pertussis vaccine has the potential to provide superior protection against B. pertussis infection and this Phase 2a study is a key next step in evaluating this important vaccine candidate.” In addition to the NIAID-sponsored Phase 2a IND filing, ILiAD announced submission to the FDA of a Company-sponsored Phase 2b IND that is intended to initiate after analysis of 1-month immunological data from the NIAID sponsored study. Dr. Rubin added, “We continue to make excellent progress in the development of BPZE1 and are advancing our vaccine technology through a robust clinical and regulatory plan. We look forward to the outcomes from these forthcoming Phase 2 studies.” BPZE1 was developed in the lab of Camille Locht, PhD, at the Institut Pasteur de Lille (IPL) and Frenc National Institute of Health and Medical research (Inserm). ILiAD Biotechnologies holds global rights to the technology and has raised more than $10 million to date to further develop the most advanced pertussis vaccine in clinical trials. BPZE1 technology is covered by 33 issued patents, with an additional 25 patents pending around the world. About Pertussis About BPZE1 About ILiAD Biotechnologies, LLC About NIAID Vanderbilt Vaccine Research Program at Vanderbilt University Medical Center "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. In addition to historical facts or statements of current, this press release may contain forward-looking statements. Forward-looking statements provide ILiAD's current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products, interpretation of clinical results, prospects for regulatory approval, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, rapid technological change, risks associated with acquisitions and investments, risks associated directly with BPZE technologies including but not limited to uncertainties of product development, and uncertainties of clinical development, dependence on third parties, competition, protection of patents and proprietary technology, potential for infringement and other statements regarding matters that are not historical fact. Some of these forward looking statements may be identified by use of words in the statements such as "estimate," "intend," or other words and terms of similar meaning. Statements in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore actual outcomes and results may differ materially from what is expressed in such forward-looking statements. ILiAD cautions investors not to place reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this release and ILiAD undertakes no obligations to update or review these statements, except as may be required by law. Press Contact: Ken Solovay COO ILiAD Biotechnologies, LLC [email protected] 954.336.0777 Craig Boerner News and Public Affairs Vanderbilt University Medical Center [email protected] 615.322.4747 |