BioPharmX Study Shows BPX-01 Topical Gel Delivers Minocycline Precisely to the Skin

MENLO PARK, Calif., July 21, 2016 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for the dermatology market, will share findings from the first comparative studies of oral and topical minocycline formulations, which detected no traces of minocycline in the bloodstream when it is applied topically.  BioPharmX conducted two directional comparative pharmacokinetics (PK) studies of oral minocycline to topical BPX-01.

The comparative studies assessed the impact of a novel topical gel formulation of 1% minocycline and compared it to an extended release oral minocycline to measure skin and plasma concentrations during four-week treatment periods. 

Results of a 28-day clinical PK study found no detectable minocycline in skin after two weeks of daily oral treatment with a 1-2 mg/kg dose, but did show minocycline concentrations in the plasma.  A separate oral gavage versus BPX-01 minipig study also found minocycline in the plasma for minipigs in the oral group, but no minocycline in the plasma for the topical group.  At the same time, the minipig study detected minocycline in the skin of the topical group, but found no minocycline in the skin of the oral group. 

BPX-01 is fully solubilized, non-oily, easy-to-use, and capable of being delivered to sebum-rich areas where P. acnes reside.

The research will be presented at the Dermatology Education Foundation™ DERM2016 NP/PA CME Conference in Las Vegas at 6 p.m. Thursday.

"These results are promising, that topical minocycline gel delivered as BPX-01, results in local skin levels of minocycline that can be effective in the treatment of acne vulgaris, while simultaneously avoiding systemic exposure based on the absence of plasma levels after topical application," said Dr. James Q. Del Rosso, of Del Rosso Dermatology Research, Las Vegas. "This provides the potential for avoiding systemic side effects that are known to occur with oral minocycline."

Acne-causing bacteria have increasingly become resistant to oral antibiotics, which are commonly used to treat moderate-to-severe cases of acne. BPX-01 is expected to deliver a reduced-dose, topical minocycline that provides targeted, localized treatment and limits systemic exposure, thus potentially decreasing dose-dependent side effects and the emergence of antibiotic resistant bacteria.

"The comparative studies' results are promising because they suggest BPX-01 may mitigate many of the undesirable side effects common to the use of oral minocycline," said Kin Chan, executive vice president of research and development.  "We are optimistic about the continuing studies to further evaluate the safety and efficacy of BPX-01."  BioPharmX expects to begin enrollment of a Phase 2b study of BPX-01 by end of summer. 

The American Academy of Dermatology calls acne the "most common skin condition in the United States," affecting 40 million to 50 million Americans at any given moment. The U.S. market for acne medications is estimated at $10 billion.

About BioPharmX® Corporation

BioPharmX Corporation (NYSE MKT: BPMX) is a Silicon Valley-based specialty pharmaceutical company that 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 Statement

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, the safety and medical effects of BPX-01, the effect BPX-01 may have on the treatment of acne and acne lesions, lack of side effects of future use of BPX-01, information being presented at Derm2016, the resistance of P. acnes bacteria to oral minocycline and the commencement of enrollment of the Phase 2b study of BPX-01.. 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.

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