MENLO PARK, Calif.,
March 22, 2016 /PRNewswire/
-- BioPharmX Corporation (NYSE MKT: BPMX), a specialty
pharmaceutical company developing products for use in dermatology
and women's health, today announced it has received institutional
review board (IRB) approval to initiate a Phase 4 study of its
Violet® molecular iodine supplement for fibrocystic breast
condition (FBC) and cyclic mastalgia.
KGK Synergize, a London,
Ontario based clinical research organization focused on
nutraceutical, biotechnology and pharmaceutical product research,
will conduct the study. The study is randomized,
double-blind, and placebo controlled to evaluate the safety,
tolerability and potential benefits of the molecular iodine dietary
supplement, Violet, on breast health in women with cyclic breast
pain and tenderness.
The planned sample size for this study is 120 females, with
approximately 80 subjects receiving Violet iodine and approximately
40 subjects receiving the placebo in a double-blind manner.
Participants will be instructed to take Violet iodine or
placebo daily for six months. Participants receiving placebo
in the first study phase will be offered three months of Violet
iodine at the conclusion of their participation in the six month
study period. Participants will record symptoms daily using a
smart phone app and complete a more in-depth on-site questionnaire
and receive a blood draw prior to the study, at three months, and
again at six months. Results from this study are expected by the
end of 2016.
"A significant number of American women suffer from breast
discomfort due to fibrocystic breast condition," said AnnaMarie Daniels, executive vice president of
clinical and regulatory affairs at BioPharmX Corporation. "The goal
of this study is to learn more about the safety and potential
benefits of Violet."
About BioPharmX
BioPharmX Corporation (NYSE MKT: BPMX) is a Silicon Valley based
specialty pharmaceutical company, which seeks to provide products
through proprietary platform technologies for prescription,
over-the-counter (OTC), and supplement applications in the health
and wellness markets, including dermatology and women's health. To
learn more about BioPharmX, visit www.BioPharmX.com.
About KGK Synergize
Established in 1997 with headquarters in Canada, and the
United States, KGK is a specialty CRO that focuses on
conducting human clinical trials for the health nutrition industry.
The company is known for developing and executing clinical studies
that meet FDA/FTC regulations and successfully support product
claims substantiation.
Forward-Looking Statements
The information in this press release contains forward-looking
statements and information within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which are subject to
the "safe harbor" created by those sections. This press release
contains forward-looking statements about the company's
expectations, plans, intentions and strategies, including, but not
limited to, statements regarding, commencement of the Phase 4 study
and results of the Phase 4 study. These forward-looking statements
may be identified by words such as "plan", "expect," "anticipate,"
"believe," or similar expressions that are intended to identify
such forward-looking statements. These forward-looking statements
involve risks and uncertainties, as well as assumptions, which, if
they do not fully materialize or prove incorrect, could cause our
results to differ materially from those expressed or implied by
such forward-looking statements. The risks and uncertainties
include those described in the company's filings with the
Securities and Exchange Commission. Given these risks and
uncertainties, you are cautioned not to place undue reliance on
such forward-looking statements. The forward-looking statements
included in this news release are made only as of the date hereof
and the company undertakes no obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise, except as may be required
under applicable securities laws.
BioPharmX and Violet are registered trademarks of BioPharmX,
Inc. All other brand names are trademarks or registered trademarks
of their respective holders.
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