Novan’s Nitric Oxide Drug Candidate Inhibits Growth of Papillomavirus in Translational Animal Model

Topical Anti-Viral Could Lead to Treatment for HPV Infections and Help Prevent Cancer

Data Presented at 2014 Interscience Conference on Antimicrobial Agents and Chemotherapy, Taking Place in Washington, DC, September 5-9, 2014

ICAAC 2014

DURHAM, N.C.--()--Novan Therapeutics, a clinical-stage biotech company focused on advancing nitric oxide therapies, announced today that Novan’s nitric oxide drug candidate SB206 was shown to inhibit papilloma growth in a preclinical animal study. About two-thirds of healthy American adults are infected with human papillomavirus (HPV), which constitutes a group of more than 100 genetically similar DNA viruses propagated primarily as sexually transmitted infections. While low-risk variants of HPV typically are associated with two types of papillomas – common warts and genital warts – high-risk strains of the virus are associated with cervical cancers, as well as cancer of the vagina, vulva, anus, rectum and penis. In total, high-risk strains of HPV account for approximately 5% of all cancers worldwide.

According to data being reported today in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), administration of high dose SB206 resulted in complete (100%) inhibition of papilloma growth in a Cottontail Rabbit Papillomavirus (CRPV) model inoculated with viral DNA that leads to slow-growing papillomas more clinically relevant to human papillomas. In contrast, lower dose oxide-releasing drug candidates and vehicle controls had minimal effect on inhibiting papilloma growth.

“It appears that the speed of treatment effects and complete cessation of wart growth suggests direct anti-viral activity,” stated Novan collaborator Dr. Neil Christensen, Professor of Pathology and Microbiology and Immunology, and Medical Director, Jake Gittlen Cancer Research Foundation, The Pennsylvania State University, College of Medicine. “This is the first time I have seen such a strong response in the CRPV model from any compound other than the more harsh, ablative agents. We have so few treatment options for HPV infection, I’m really looking forward to the clinical development of Novan’s drug as a potential replacement for the ‘watch and wait’ treatment paradigm.”

Further, the CRPV model has been previously utilized to answer questions on cancer progression and provided animal proof-of-concept data that led to the development of the currently available HPV vaccines.

Dr. Nathan Stasko, Novan’s President, stated, “This work is transformational given the predictive power of this well-characterized anti-viral model. Our novel approach for developing an HPV treatment involves stably storing nitric oxide in a topical gel that can be applied to mucosal and cutaneous surfaces. We now can use the naturally occurring molecule as an antiviral agent that mimics the immune system in a site specific, localized fashion.” Based on the positive preclinical results and the progress of the company’s other programs, Novan anticipates initiating a Phase 2 clinical trial against HPV in the second half of 2015.

Robert Ingram, a Director of Novan Therapeutics and Past Chairman and Co-Founder of the CEO Roundtable on Cancer, commented, “If we, as a global community, had a safe drug for the eradication of HPV, in theory, 1 out of every 20 cancers could be prevented. I cannot imagine a more meritorious and impactful extension of Novan’s drugable nitric oxide platform.”

Presentation Number V-1822a: “Antiviral Efficacy of Nitric Oxide-Releasing Drug Candidates In Vivo Utilizing the Cottontail Rabbit Papillomavirus Model,” K. Coggan, K. Balogh, S. Hollenbach, N. Christensen, and N. Stasko

Presenter: Kimberly Coggan, Ph.D., Molecular Microbiologist, Novan Therapeutics

Session Date, Time and Location: Monday, September 8, 2014; 11:00 a.m. – 1:00 p.m. EDT; Exhibit Hall B

About Novan, Inc.

Novan Therapeutics is a privately-held, clinical stage biotech company focused on advancing nitric oxide therapies. Nitric oxide, one of the most studied molecules in human physiology, has been shown to exhibit anti-microbial activity and to promote vasodilation, regulate inflammation, stimulate tissue repair and eradicate cancer cells. Novan’s core technologies solve the previous delivery issues with nitric oxide by stably storing the gaseous species on macromolecules that result in a diverse pipeline of “timed-release” nitric oxide-releasing new chemical entities. The company's proprietary platform technology enables drugable nitric oxide in a variety of dosage forms.

This press release contains forward-looking statements involving risks and uncertainties, both known and unknown, that may cause actual results to differ materially from those indicated. Actual results may differ materially due to a number of factors, including, but not limited to, risks associated with pharmaceutical development, clinical trials that cost more, are less effective and take longer to complete than expected, raw materials and drug supply, changes in regulatory requirements, competition and financing.

To learn more about Novan Therapeutics, please visit www.novantherapeutics.com.

Contacts

Justin Jackson, Burns McClellan, on behalf of Novan Therapeutics
212-213-0006, ext.327
jjackson@burnsmc.com

Contacts

Justin Jackson, Burns McClellan, on behalf of Novan Therapeutics
212-213-0006, ext.327
jjackson@burnsmc.com