SUNDAY, SEPTEMBER 25, 2016

NovaDigm announces successful preclinical trial of NDV-3 vaccine against VVC

NovaDigm Therapeutics announced a successful preclinical trial on Thursday of its NDV-3 vaccine against vulvovaginal candidiasis in patients with recurrent VVC.

"An active immunotherapy approach such as NDV-3 has unique potential to address the significant need for improved long-term control of RVVC the market for which could reach over $1 billion worldwide" NovaDigm Chief Executive Officer Timothy Cooke said. "The initiation of this trial follows a preclinical study in a model of VVC which demonstrated that NDV-3 induced potent and protective immune responses as well as two successful Phase 1 studies which demonstrated that NDV-3 was safe well-tolerated and induced strong antibody and T-cell immune responses in healthy adults. In addition to RVVC NovaDigm is also continuing to advance NDV-3 for other infectious disease indications such as skin and soft tissue infections caused by drug-resistant Staphylococcus aureus and nosocomial infections caused by drug-resistant Staphylococcus aureus and Candida."

The double-blind, randomized and placebo-controlled trial is being conducted across multiple centers.

NDV-3 was developed to help prevent infections caused by the fungus Candida and the bacterium Staphylococcus aureus, including methicillin-resistant SA. NDV-3 is the first vaccine to prove successful in preclinical trials against both bacterial and fungal pathogens.

"RVVC symptoms cause severe negative impact on an affected woman's quality of life and continuously treating the condition has a financial impact as well" Professor Jack D. Sobel, chief of the Division of Infectious Diseases at the Wayne State University School of Medicine and a renowned international expert on vulvovaginal candidiasis, said. "Currently available over-the-counter and prescription anti-fungal medications can be fairly effective at controlling existing infections but they do not prevent future infections without chronic use. NDV-3 has the potential to provide better long-term control of symptoms for patients suffering from RVVC and an improved quality of life."

The next phase of clinical trials will be conducted within the next six to 12 months to observe safety and tolerability of the vaccine.