WELLEX, in collaboration with Natural Products Canada, is pleased to announce that Health Canada has granted approval to proceed with a human clinical trial on its flagship product, Papillex®. This trial marks a major step forward in the company's commitment to supporting women's health with evidence-based natural health products.

The approved 18-month study will assess the nutritional support potential of Papillex® in individuals with persistent HPV infections. The trial design was developed with input from Dr. Hui (Amy) Chen, a gynecologic oncologist at the University of California, Davis, and will be conducted by KGK Science, a leading North American contract research organization with over 28 years of clinical research experience. KGK also led the successful submission to Health Canada, securing the necessary approval to initiate the clinical trial.

This milestone builds on the success of a previously completed observational study on Papillex® and represents WELLEX’s dedication to rigorous scientific research in the field of cervical health. The trial is intended to provide further insights into the role of targeted nutritional support in immune and cervical health—an area of significant public health interest.

“This approval from Health Canada is a meaningful milestone for our team and for the thousands of women seeking proactive, natural support for their cervical health, especially in cases of HPV persistence,” says Dr. Elizabeth Goldspink, ND, founder of WELLEX. “Our goal has always been to bring trustworthy, evidence-informed solutions to the forefront, and this human clinical trial reflects our unwavering commitment to that mission.”

"We're excited to congratulate WELLEX on achieving Health Canada approval for their Papillex® human clinical trial -- a significant milestone that demonstrates the caliber of innovation emerging from our Game Changers portfolio," adds Shelley King, CEO, Natural Products Canada. "WELLEX’s evidence-based approach to women's health exemplifies how Canadian companies are capturing opportunities in the global bioeconomy. NPC invested in their work to transform their promising innovation into a market-ready solution, and we are thrilled that they have achieved this major step on their commercialization pathway."

WELLEX currently offers a line of products formulated to support women’s health, including Papillex®, Simplix®, IC Well, Endo Well, and PCO Well, which are available to healthcare professionals and clients across Canada and the U.S. The company remains focused on supporting clinical research and practitioner education as part of its long-term strategy.

About WELLEX

WELLEX is a Canadian company dedicated to advancing women’s health. Founded by Dr. Elizabeth Goldspink, ND, WELLEX formulates research-informed natural health products designed to support women’s health. All products are third-party tested and manufactured in GMP-certified facilities in North America.

About Natural Products Canada

Natural Products Canada (NPC) is the driving force behind Canada’s Natural Product Innovation Cluster–a strategic and diverse community focused on the development and commercialization of naturally-derived products and technologies in health and life sciences, natural resources, agriculture and agri-food, and sustainable bioproducts. As part of its role in the Cluster, NPC offers in-depth advice and a suite of commercialization programs to Canadian early-stage companies and research institutes; provides connections and innovation scouting services to corporations and investors; and leverages an investment fund (Nàdarra Ventures) to help develop and de-risk promising Canadian opportunities. NPC has received financial support from the Government of Canada’s Strategic Innovation Fund, administered by the department of Innovation, Science and Economic Development, and the Centre of Excellence in Commercialization and Research (CECR) program, administered by the Networks of Centres of Excellence.

About KGK Science

KGK is a premier North American contract research organization (CRO), specializing in high-quality clinical research for nutraceuticals and other emerging health products. Since its founding in 1997, KGK has supported hundreds of companies in bringing innovative products to global markets through custom-designed clinical trials and effective claim substantiation strategies. In addition to clinical research, KGK also offers comprehensive regulatory support, and consulting services. The company has conducted over 400 clinical trials across more than 40 health indications and contributed to over 150 peer-reviewed publications.

About Dr. Hui (Amy) Chen, MD

Dr. Hui (Amy) Chen is a gynecologic oncologist at UC Davis Comprehensive Cancer Center with a clinical and research interest in integrative oncology and women’s health.

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“Our goal has always been to bring trustworthy, evidence-informed solutions to the forefront, and this human clinical trial reflects our unwavering commitment to that mission.” Dr. Elizabeth Goldspink, ND, founder of WELLEX.