Company shifts focus of human cell and tissue products to biopharmaceuticals
SALT LAKE CITY (May 14, 2019) – Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent precision therapeutic intervention, announces the signing of a letter of intent with IQVIA (Formerly Quintiles and IMS) to guide the regulatory strategy for its wholly owned subsidiary Predictive Biotech. This collaboration will accelerate the process of identifying and executing the appropriate regulatory pathways for the Company’s existing products and future product candidates.
Specifically, IQVIA will guide Predictive Biotech in its U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application and subsequent clinical trial for osteoarthritis (OA) of the knee. The Company expects to meet with the FDA during the third quarter of 2019 to discuss the submission of the IND with the objective of determining the safety and effectiveness of CoreCyte™ compared to a placebo control for treatment of OA of the knee. The Company will work with the FDA to determine if the FDA will accept the current safety data from over 75,000 patients previously treated with CoreCyte™.
Eric Olson, Predictive Biotech President and CEO, said, “This OA of the knee study is the first of several trials that Predictive Biotech intends to conduct for our cellular therapy injectable products. We are excited to leverage IQVIA’s expertise as we expand our focus from human cell and tissue products (HCT/Ps) into the biopharmaceutical market.”
Given the lack of effective treatment options for patients with OA of the knee, and the high risks associated with using opioids to manage pain, the Company anticipates seeking an accelerated Regenerative Medicine Advanced Therapy (RMAT) designation.
“CoreCyte™ has the opportunity to address a significant unmet clinical need by providing an alternative to opioids, cortisone and/or hyaluronic injections for treating OA knee pain,” added Olson.
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com; Predrx.com; Predictivebiotech.com; and Predictivelabs.com.
About Predictive Biotech, Inc.
Predictive Biotech, Inc., a Salt Lake City, UT life sciences Company formed in 2015, is a leader in human cell and tissue products for use in cellular therapies and regenerative medicine. A growing national network of clinics, health systems, researchers and physicians leverage Predictive’s four main placental-derived and Wharton’s Jelly umbilical cord-derived products. Predictive Biotech’s current products are regulated by the FDA under 21 CFR part 1271 section 361 as minimally manipulated allografts intended for homologous use.
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.