Novan Awarded Approximately $1.1 Million Grant by Department of Defense
September 20 2019 - 8:30AM
Novan, Inc. ("the Company" or "Novan") (Nasdaq:NOVN) today
announced that the Company has received a grant from the U.S.
Department of Defense’s (DoD) Congressionally Directed Medical
Research Programs (CDMRP) of approximately $1.1 million as part of
its Peer Reviewed Cancer Research Program.
The grant will support the development of a
product candidate (WH504) for the treatment of cervical
intraepithelial neoplasia (CIN), with well-characterized physical
chemical properties suitable for intravaginal administration. In
addition, the grant will support the evaluation of the effect of
varying concentrations and treatment durations of berdazimer sodium
(NVN1000) against HPV-18 in human raft cell culture in vitro
studies. There are, currently, no FDA-approved therapeutics
indicated to treat CIN. The current standard of care is “watch and
wait” or in-office procedures depending on severity. This targeted
research aims to create a disease-altering treatment that could be
used upon detection and the early signs of high-risk HPV infection
to intervene before progression to cervical cancer.
This grant is in addition to the previously
announced National Institute of Health (NIH) Phase 1 grant of
approximately $223,000 for the development of a separate product
candidate (WH602). Both product candidates will represent core
initiatives within the previously announced Novan women’s health
business unit.
The views expressed in this press release are those of the
Company and may not reflect the official policy or position of the
Department of the Army, Department of Defense, or the U.S.
Government.
About Cervical Intraepithelial Neoplasia
(CIN)
Cervical intraepithelial neoplasias (CIN), or
precancerous lesions of the cervix caused by persistent high
risk-human papilloma virus (HPV) infection, are categorized by HPV
genotype and the depth of the infection within the epithelial
tissue of the cervix, with grades 1 and 2 considered precancerous
and grade 3, carcinoma in situ. While there are an estimated
250,000 to 1 million women diagnosed with CIN annually in the U.S.,
there are no minimally invasive therapies with direct antiviral
activity for the treatment of CIN and excisional procedures are
often associated with pain, fertility issues and recurrence.
Despite the availability of the prophylactic HPV vaccines, the
incidence of HPV-induced cancer is steadily increasing, due to (a)
the inability of the vaccine to cure preexisting infections; (b) a
great majority of adolescent populations is not vaccinated; and (c)
high rate of population growth. According to a survey on U.S.
cervical cancer mortality rates, each year, nearly 12,000 women in
the U.S. will be diagnosed with cervical cancer and more than 4,000
will die from the cancer.
About Novan
Novan, Inc. is a clinical development-stage
biotechnology company focused on leveraging nitric oxide’s
naturally occurring anti-microbial and immunomodulatory mechanisms
of action to treat a range of diseases with significant unmet
needs. We believe that our ability to deploy nitric oxide in a
solid form, on demand and in localized formulations allows us the
potential to improve patient outcomes in a variety of dermatology,
women’s health and gastrointestinal diseases.
Forward-Looking Statements
This press release contains forward-looking
statements including, but not limited to, statements related to
pharmaceutical development of nitric oxide-releasing product
candidates, our intention to advance development of nitric
oxide-releasing product candidates and the 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, risks and uncertainties in our
ongoing or future product development activities and preclinical
studies, which may not prove successful in demonstrating proof-of
concept, or may show adverse toxicological findings, and even if
successful may not necessarily predict that subsequent clinical
trials will show the requisite safety and efficacy of our product
candidates; the clinical development process, including, among
others, length, expense, ability to enroll patients, reliance on
third parties, potential for delays; the regulatory approval
process, which is lengthy, time-consuming and inherently
unpredictable, including the risk that our product candidates may
not be approved or that additional studies may be required for
approval or other delays may occur and that we may not obtain
funding sufficient to complete the regulatory or development
process; our ability to meet any of the requirements under the
grants described above and the uncertainty involved with
government grants, including the successful negotiation and
availability of funding for the grants described above or any other
grants to support funding for a women’s health product candidate;
our ability to obtain additional funding or enter into strategic
relationships or other business development necessary for the
further development of our product candidates; and other risks and
uncertainties described in our annual report filed with the SEC on
Form 10-K for the twelve months ended December 31, 2018, and in our
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.
CONTACT:
(Investors & Media)Cole IkkalaDirector,
Investor Relations, Communications & Business
Developmentcikkala@novan.com
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