MENLO PARK, Calif.,
Sept. 12, 2017 /PRNewswire/ --
BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical
company focusing on dermatology, is announcing preliminary data
from a feasibility study of BPX-01 to assess the safety and
efficacy of topical minocycline gel at both the 1% and 2% doses for
the treatment of rosacea. The preliminary data from the
ongoing study suggest good tolerability and promising efficacy of
BPX-01 in this indication and highlight the value of BioPharmX's
dermatology delivery system.
This ongoing 12-week, open-label feasibility study to assess the
safety and efficacy of BPX-01 topical minocycline gel in rosacea
patients enrolled 20 subjects with moderate-to-severe
papulopustular rosacea, who applied BPX-01 once daily. Safety
was assessed by reviewing treatment emergent adverse events, shifts
from baseline in hematology and chemistry laboratory tests as well
as cutaneous tolerance scores as assessed both by study subjects
and investigators. The preliminary data show that BPX-01 was well
tolerated in all subjects treated to date. No adverse events were
determined to be treatment related and there were no clinically
significant shifts from baseline in hematology and chemistry
laboratory tests.
The primary efficacy endpoint from this study is change in
Investigator's Global Assessment (IGA) of rosacea at 12
weeks. The secondary efficacy endpoint is change in facial
lesion count from baseline at 12 weeks. The preliminary data
obtained to date suggest a positive effect on rosacea
lesions. Of the 15 subjects that have completed 12 weeks of
treatment in the study, 100% have IGA scores of clear (0) or almost
clear (1), compared to their baseline scores of moderate
(3) or severe (4). Investigators also observed a 93% reduction in
total inflammatory lesions from baseline to week 12 in
the same subjects who have completed the 12-week study.
"BPX-01 has been well tolerated by the study subjects," said Dr.
Neal Bhatia, a board-certified
dermatologist at Therapeutics Clinical Research who is the study's
principal investigator. "We are pleased with the initial data
on efficacy. We look forward to the final results of the
study and determining next steps."
Company executives said they expect to pursue additional
research to evaluate the efficacy of BPX-01 in rosacea.
"These preliminary results are encouraging and give us guidance
as we evaluate our clinical development plan for rosacea. They also
reinforce the potential value of our unique drug delivery platform
across various dermatology indications," said Anja Krammer, president of BioPharmX.
"Additionally, we are excited by the prospect that it may offer
rosacea patients a long-overdue therapeutic innovation."
About BPX-01
BPX-011 is a hydrophilic
(non-oil-based) topical gel with fully solubilized minocycline that
has been shown to penetrate the skin to deliver the antibiotic to
its target. Following positive results from its previously
announced phase 2b study of BPX-01 in acne, BioPharmX continues
with phase 3 clinical study plans for BPX-01 for the treatment of
acne.
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 (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.
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 the
safety and medical effects of BPX-01, the effect BPX-01 may have on
the treatment of acne and rosacea, the commencement and results of
future trials of BPX-01 and the size of such trials, continued and
consistent results in future tests of BPX-01 and absence of side
effects of future use 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,
including our annual report on Form 10-K for the period
ended Jan. 31, 2017 and our quarterly report on Form 10-Q for
the period ended April 30, 2017.
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
law.
BioPharmX is a registered trademark of BioPharmX, Inc.
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1Caution: BPX-01 is a new
drug limited by U.S. law to investigational use.
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SOURCE BioPharmX Corporation