The study, part of BioPharmX's assessment of the effectiveness of its unique BPX-01 topical minocycline formulation, suggests that the effectiveness of minocycline's anti-inflammatory properties against P. acnes-stimulated keratinocytes may be realized in a topical formulation.
Recent studies found that inflammation – long thought to be a side-effect of P. acnes – may actually be the underlying cause of acne. That would mean any formulation that delivers minocycline's anti-inflammatory benefits of lesion count and lesion size reduction – as well as its antibacterial benefits – would optimize the drug's therapeutic value for prescribing physicians.
"Our research suggests that topical minocycline may deliver an anti-inflammatory benefit," said Kin F. Chan, executive vice president of research and technology. "Our previous research showed that topical minocycline is effective at doses far lower than those typically found in oral formulations, thereby reducing side-effect risks. This further analysis suggests that a topical formulation of minocycline unleashes other biological benefits that are independent of its anti-microbial activity."
BPX-01 is the first and only stable hydrophilic (non-oil-based) topical gel with fully solubilized minocycline that can penetrate the skin to deliver the antibiotic to the layer of skin where the acne develops in the pilosebaceous unit. The company's studies are designed to confirm whether BPX-01 will effectively treat acne with lower, and potentially safer, dosages of the antibiotic.
BioPharmX has just initiated a Phase 2b dose-finding study, called the OPAL Trial (tOPicAL minocycline gel), a 12-week, multi-center, randomized, double-blind, three-arm, vehicle controlled study and will enroll 225 subjects, aged 9 to 40, with moderate-to-severe inflammatory, non-nodular acne vulgaris.
The American Academy of Dermatology calls acne the "most common skin condition in the United States," affecting 40 million to 50 million Americans. 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 dermatology and women's health. To learn more about BioPharmX, visit www.BioPharmX.com.
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, whether topical minocycline is effective in fighting P. acnes-induced inflammation in human keratinocytes, the results of the OPAL Trial and whether the results of the OPAL Trial are consistent with Company expectations. 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