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MORRISVILLE, N.C., March 02, 2017 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today announced that data from the Company’s Phase 2 clinical trial with SB206 for the treatment of genital warts caused by human papillomavirus, or HPV, will be presented during a Late-breaking Research forum at the 2017 Annual Meeting of the American Academy of Dermatology, or AAD, in Orlando, Florida.
Stephen Tyring, M.D., Ph.D., is scheduled to present “Results From Phase II Study of Nitric Oxide-Releasing SB206 Once Daily Administration Show Favorable Efficacy and Safety in Genital Warts” on Saturday, Mar. 4. Dr. Tyring was one of the investigators in this clinical trial and is a board-certified dermatologist at the Dermatological Association of Texas in Houston and professor of dermatology at the University of Texas Health Science Center at Houston McGovern Medical School.
“The data from this clinical trial demonstrated the very real potential of Novan’s topical nitric oxide-releasing product candidate, SB206, against genital warts,” said Dr. Tyring. “Patients treated with SB206 12% once-daily experienced a statistically significant benefit in wart clearance as compared to those treated with vehicle, with low rates of application site adverse events and treatment discontinuations. If approved, SB206 could be a novel approach and an important alternative to current treatment paradigms that are often painful.”
About the Presentation
Abstract Number: 5220
Title: “Results From Phase II Study of Nitric Oxide-Releasing SB206 Once Daily Administration Show Favorable Efficacy and Safety in Genital Warts”
Authors: S. Tyring, V. Almendarez, J. Scoggin
Presenter: Stephen Tyring, M.D., Ph.D.
Date and Time: Saturday, Mar. 4, 2017, 9:50 – 10:00 a.m. Eastern Time
Session: F056, Late-breaking Research: Clinical Trials
About Human Papillomavirus and Genital Warts
HPV refers to a large family of double-stranded DNA viruses that induce abnormal growths on the skin or mucosal surfaces. HPV affects nearly 80 million Americans, and an estimated 14 million new cases of the virus are reported each year, according to the Centers for Disease Control and Prevention, or CDC. There are over 100 subtypes of the virus, characterized as low-risk or high-risk based on their cancer-causing potential. The virus is typically transmitted via direct skin-to-skin contact through disruptions in the normal skin barrier. All warts are caused by HPV, including genital and perianal warts, common warts and plantar warts.
Genital warts are among the world's most common sexually transmitted diseases. Genital warts are usually flesh-colored growths that can be raised, flat or cauliflower-shaped and are typically found on the surface of the external genitalia or in and around the anus. In males, they can appear on the surface of the penis and scrotum, and in females inside the vagina or on the cervix. Genital warts carry a substantial psychosocial burden due to the shame and embarrassment related to having a sexually transmitted disease as well as the inconvenience and discomfort of current treatment modalities. Current treatment options for genital warts consist of ablative procedures that cut, burn or freeze the warts but do not address the underlying viral infection, and there are no currently approved oral or topical prescription products indicated for the treatment of genital warts with a direct anti-viral mechanism of action.
Novan, Inc. is a late-stage pharmaceutical company focused on redefining the standard of care in dermatology through the development and commercialization of innovative therapies using the Company’s nitric oxide-releasing platform. Nitric oxide plays a vital role in the natural immune system response against microbial pathogens and is a critical regulator of inflammation. Our ability to harness nitric oxide and its multiple mechanisms of action has enabled us to create a platform with the potential to generate differentiated, first-in-class product candidates. We are rapidly advancing programs in five dermatological conditions with significant unmet medical need. We believe that our ability to conveniently deploy nitric oxide on demand in topical formulations allows us the potential to significantly improve patient outcomes in a variety of skin diseases and positions us to be a commercially successful leader in the dermatology market.
For more information, visit the Company’s website at www.Novan.com.
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates, expected performance of our product candidates, publication and presentation of our trial results in the medical community and future prospects of our business and our product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, uncertainties and risks in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research or trials; the lengthy and unpredictable nature of the U.S. Food and Drug Administration’s drug approval process; whether we will be able to obtain additional funding when needed; and other risks and uncertainties described in our prospectus dated Sept. 20, 2016, filed with the Securities and Exchange Commission, or SEC, in our quarterly report filed with the SEC on Form 10-Q for the three months ended Sept. 30, 2016, and in any subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
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