BioPharmX commences Phase 2 clinical study under U.S. FDA IND for BPX-01

Mar 03, 2016, 09:00 ET from BioPharmX Corporation

MENLO PARK, Calif., March 3, 2016 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company focusing on dermatology and women's health, today announced that it will immediately commence a Phase 2a clinical study under its U.S. FDA Investigational New Drug (IND) application for BPX-01, a hydrophilic formulation of the well-established drug minocycline.  This clinical study will assess effectiveness in reducing the number of acne-causing bacteria in study patients at four weeks and evaluate the drug's safety and tolerability.  This is the first clinical study in the clinical development program for BPX-01.

The clinical study will be conducted by KGL Skin Center, a Philadelphia-based independent clinical research facility recognized as a leader in clinical testing of cosmetics, personal care products, over-the-counter and prescription drugs, and devices for the skin.  The principal investigator is Dr. Stuart Lessin, a board-certified dermatologist who serves as KGL's medical director.

The company's preclinical studies have found the unique gel formulation of minocycline in BPX-01 can deliver the antibiotic to the layer of skin where the condition develops, suggesting that the skin penetration needed to reach an efficacious dose in humans while minimizing systemic exposure is possible.

"We are excited to begin our IND study of BPX-01," said Kin F. Chan, Ph.D., executive vice president of research and development at BioPharmX Corporation. "Our nonclinical research has been well received by the dermatology community."

Most topical antibiotic acne medications available today have become less effective in killing the acne-causing bacteria or have difficulties delivering adequate levels of antibiotic to the epidermis and the pilosebaceous region where acne develops. The hydrophilic (non-oil based) BPX-01 formulation is designed to distribute evenly, not be sticky and not occlude or irritate the skin, an advantage in the treatment of acne.

The American Academy of Dermatology calls acne the "most common skin condition in the United States," affecting 40 million to 50 million Americans.

About BioPharmX® Corporation
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, and supplement applications in the health and wellness markets, including dermatology and women's health. To learn more about BioPharmX, visit www.BioPharmX.com.

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 section.   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 our Phase 2a study and the effectiveness of the BPX-01 gel. 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 is a registered trademark of BioPharmX, Inc.

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SOURCE BioPharmX Corporation



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