Health Canada Approves BioPharmX Corporation Study
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Posted On: 04/04/2016 8:49:47 AM
Health Canada Approves BioPharmX Corporation Study of Violet® Iodine
BioPharmX engages KGK Synergize, Inc. to manage its Canadian phase 4 study for Violet molecular iodine breast health supplement
MENLO PARK, Calif., April 4, 2016 – BioPharmX Corporation (NYSE MKT: BPMX), specialty pharmaceutical company developing products for use in dermatology and women’s health, today announced Health Canada has approved the Canadian expansion of a Phase 4 study of the company’s Violet® molecular iodine supplement for fibrocystic breast condition (FBC) and cyclic mastalgia. Last month, the Food and Drug Administration approved the study in the United States.
KGK Synergize, a London, Ontario-based clinical research organization focused on nutraceutical, biotechnology and pharmaceutical product research, will conduct the study. The investigation is a randomized, double-blind, placebo controlled, multi-center study to evaluate the safety, tolerability and potential benefits of the molecular iodine dietary supplement, Violet, on breast health in women with cyclic breast pain and tenderness.
Results from this study are expected by the end of 2016.
“At least 875 million reproductive-age women around the world suffer from breast pain and discomfort due to fibrocystic breast condition,” said AnnaMarie Daniels, executive vice president of clinical and regulatory affairs at BioPharmX. “Previous studies have shown that molecular iodine results in a significant reduction in the symptoms of FBC. The goal of this study is to learn more about the safety and potential benefits of molecular iodine to expand claims and support commercialization of Violet iodine in international markets where the number of women with this condition is expected to grow to over a billion by 2050.”
BioPharmX engages KGK Synergize, Inc. to manage its Canadian phase 4 study for Violet molecular iodine breast health supplement
MENLO PARK, Calif., April 4, 2016 – BioPharmX Corporation (NYSE MKT: BPMX), specialty pharmaceutical company developing products for use in dermatology and women’s health, today announced Health Canada has approved the Canadian expansion of a Phase 4 study of the company’s Violet® molecular iodine supplement for fibrocystic breast condition (FBC) and cyclic mastalgia. Last month, the Food and Drug Administration approved the study in the United States.
KGK Synergize, a London, Ontario-based clinical research organization focused on nutraceutical, biotechnology and pharmaceutical product research, will conduct the study. The investigation is a randomized, double-blind, placebo controlled, multi-center study to evaluate the safety, tolerability and potential benefits of the molecular iodine dietary supplement, Violet, on breast health in women with cyclic breast pain and tenderness.
Results from this study are expected by the end of 2016.
“At least 875 million reproductive-age women around the world suffer from breast pain and discomfort due to fibrocystic breast condition,” said AnnaMarie Daniels, executive vice president of clinical and regulatory affairs at BioPharmX. “Previous studies have shown that molecular iodine results in a significant reduction in the symptoms of FBC. The goal of this study is to learn more about the safety and potential benefits of molecular iodine to expand claims and support commercialization of Violet iodine in international markets where the number of women with this condition is expected to grow to over a billion by 2050.”
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