NovaDigm announces data from NDV-3 vaccine Phase 1 study on Candida and Staph infections

NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced the publication of data from its first-in-human Phase 1 study of its NDV-3 vaccine program in the journal Vaccine. The data demonstrate that a single dose of NDV-3 with alum adjuvant was safe, well-tolerated and induced strong antibody and T-cell immune responses in healthy adults.

NDV-3 is a vaccine being developed for the treatment and prevention of infections caused by the fungus Candida and the bacterium Staphylococcus aureus (including methicillin-resistant S. aureus, or MRSA). NDV-3 is the first vaccine to demonstrate preclinical "cross-kingdom" protective efficacy against both fungal and bacterial pathogens.

"The publication of this positive data provides further validation for NovaDigm as we prepare to begin a Phase 2 efficacy study with an optimized vaccine formulation in the first half of 2013," said Timothy Cooke, Ph.D., NovaDigm's Chief Executive Officer. "We are encouraged that NDV-3 was shown to be safe and well-tolerated, with a very promising immunogenicity profile, in two Phase 1 studies. We are confident that it can play an important role in treating community- and hospital- acquired infections caused by these pathogens, which represent significant medical needs and large commercial potential."

"There is a great need for vaccines that can safely treat the wide array of infections caused by both Candida and Staph aureus," commented John Hennessey, Ph.D., corresponding author of the study and Vice President of Research & Development at NovaDigm. "In addition to the rapid antibody responses following a single dose, there were also substantial T-cell responses. These included responses to Th1 and Th17 T-cells, which are believed to be important for protection against both Candida and Staph aureus. This study is also the first to demonstrate vaccine-induced Th17 responses in humans."

The objectives of this first-in-human Phase 1 clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive NDV-3 containing either 30 µg or 300 µg of the Als3 antigen with alum adjuvant or placebo. The trial data published in Vaccine indicated that NDV-3 was safe and well-tolerated after one or two doses, with the most common adverse event being injection site pain that was typically mild and lasted 1 to 2 days after vaccination.

Both dose levels resulted in 100% seroconversion for both serum immunoglobulin G (IgG) and serum immunoglobulin A1 (IgA1) antibodies by day 14, with greater than 50% seroconversion by day seven in the higher dose group. The geomean fold rise in IgG and IgA1 antibody titers by day 14 post-vaccination for the higher dose group were 65- and 45-fold, respectively. Geomean IgG and IgA1 titers over the course of 28 days were significantly greater in the 300 µg dose level compared to the 30 µg dose level. Results of the study showed that the majority of subjects that received NDV-3 demonstrated significant Als3-stimulated production of the cytokines IL-17A and IFN-γ between seven and 28 days post-vaccination relative to subjects receiving placebo.

The article, titled "NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus is safe and immunogenic in healthy adults," was published in the current print issue of the journal Vaccine (Volume 30, Issue 52, December 14, 2012). The study's authors were: Clint S. Schmidt, C. Jo White, Ashraf S. Ibrahim, Scott G. Filler, Yue Fu, Michael R. Yeaman, John E. Edwards Jr. and John P. Hennessey Jr.

Top-line results reported in May 2012 from a second Phase 1 trial in 160 volunteers showed that single doses of three different formulations and two routes of administration of NDV-3 were safe, well-tolerated and highly immunogenic. The Company believes the two Phase 1 studies provide a strong foundation for further clinical development. NovaDigm is preparing to initiate a Phase 2 efficacy trial in 2013 in women with chronic vaginal Candida (yeast) infections.




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