Health Canada and the Natural Health Products Directorate (NHPD) recently contacted Sunbio CORP with regards to the Natural Products License registration and approved of the use of EstroG-100 in Canada. Sunbio was issued Product License Number 80026169 for EstroG-100. This designation will henceforth allow Sunbio's Canadian partners to experience menopausal symptom improvement in up to ten areas.
The United States FDA provided Sunbio with a letter of no objection in October 2010, in response to Sunbio's EstroG-100 filing for an NDI, or New Dietary Ingredient status. The recent validation of EstroG-100 by Health Canada reinforces the efficacy, safety and performance of EstroG-100 by allowing for resale in the American and Canadian markets. The support of the United States and Canada together represents a bookend for the body of work and clinical evidence built up over the past 6 years on EstroG-100. This includes a Phase I and a Phase II human clinical, a 4 week Tox, a 13 week Tox, 3 Genetic Tox studies, a Binding Affinity test using the model created by NIH, a MCF-7 in vitro analysis showing no cancer affinity, and a liver protective study as validated by WHO.
Also, EstroG-100's USA-based Phase II, randomized, placebo controlled, human clinical study was recently and successfully peer-reviewed. These results will be published in the Journal of Phytotherapy Research in the coming months. EstroG-100 is a game changer: the Phase II clinical results showed significant improvement in 10 of 12 end points within the Kupperman model while also utilizing the entire KMI Index.
Sunbio CORP specializes in the translation of cultural remedies into prospective, commercial ingredients, and is validated by Phase I and Phase II human clinical studies.