Novan Receives Phase 2 NIH Federal Grant of Approximately $1.0 Million
February 20 2020 - 8:15AM
Novan, Inc. ("the Company" or "Novan") (Nasdaq:NOVN) today
announced that the Company has received approximately $1.0 million
funding from the National Institutes of Health (NIH) to cover the
first year of a two-year Phase 2 federal grant. Novan is eligible
to receive approximately $500,000 of additional funding for the
second year, subject to availability of NIH funds and satisfactory
progress of the project. This grant is additive to the
approximately $223,000 Phase 1 NIH grant received in August 2019.
The grant will provide reimbursement for certain
project expenses related to the advancement of WH602, a central
focus of Novan’s women’s health business unit. WH602 is a nitric
oxide-containing intravaginal gel product candidate for the
treatment of cervical intraepithelial neoplasia (CIN). There are an
estimated 250,000 to 1 million women newly diagnosed with CIN
annually in the U.S., creating a significant patient care
need.
The Company expects to use the grant to support
the following objectives:
- Evaluate the intravaginal antiviral activity of WH602 in
collaboration with Neil Christensen, Ph.D., Medical Director of the
Jake Gittlen Laboratories for Cancer Research at Penn State College
of Medicine. Dr. Christensen has developed a mouse model that
enables evaluation of potential therapeutics in a preclinical
setting that will inform clinical study design if the product
candidate advances to human clinical trials. The specific focus of
the work with Dr. Christensen is to ensure the nitric oxide
delivery from the intravaginal gel replicates antiviral activity of
nitric oxide previously demonstrated to be effective against
papillomavirus in Novan’s clinical and in vitro studies.
- Deepen the mechanistic understanding of the antiviral activity
of Novan’s proprietary nitric oxide delivery platform against human
papillomavirus in collaboration with a research team from the
Department of Biochemistry and Molecular Genetics at the University
of Alabama at Birmingham led by N. Sanjib Banerjee, Ph.D., Thomas
R. Broker, Ph.D., Founding President of the International
Papillomavirus Society, and Louise T. Chow, PhD, Member of the U.S.
National Academy of Sciences and of Academia Sinica (Taiwan).
- Complete or advance certain investigational new drug
(IND)-enabling toxicology and pharmacology studies and other
preclinical activities required by the Food and Drug Administration
(FDA) to advance product candidates to human clinical trials in
antiviral indications.
The Company will continue to be supported
through a collaboration with Health Decisions, Inc. (“Health
Decisions”). Health Decisions is expected to provide consultation
and insights for these initiatives and is expected to be involved
in the first-in-human clinical studies, if the product candidates
advance into the clinic.
The research will be supported by the National
Institute Of Allergy And Infectious Diseases of the National
Institutes of Health under Award Number R44AI143022.
About Cervical Intraepithelial Neoplasia
(CIN)
Cervical intraepithelial neoplasias (CIN), or
precancerous lesions of the cervix caused by persistent high-risk
human papillomavirus (HPV) infection, are categorized by HPV
genotype and the depth of the infection within the epithelial
tissue of the cervix. The CIN classifications include CIN 1
(low-grade neoplasia), CIN 2 (moderate) and CIN 3 (severe and
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, the future prospects of
additional grant funding and third-party cooperation 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 and that results of earlier research and preclinical or
clinical trials may not be predictive of results, conclusions or
interpretations of later research activities or additional trials;
risks related to 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 reliance on third parties;
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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