BioPharmX commences Phase 2 clinical study under U
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Posted On: 03/03/2016 9:19:00 AM
BioPharmX commences Phase 2 clinical study under U.S. FDA IND for BPX-01
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.
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.
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