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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