Cord Blood Banking Leader Cryo-Cell Announces Its Intent to Advance Clinical Trials
OLDSMAR, Fla., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Cryo-Cell International, Inc. (The Nasdaq Stock Market Symbol: CCEL) (the “Company”), the world’s first private cord blood bank to separate and store stem cells in 1992, announces further plans for its newly developed Institute for Cellular Therapies. As a result of the exclusive license agreement signed with Duke University on February 26, 2021, Cryo-Cell acquired exclusive commercial rights to a range of intellectual property assets and FDA regulatory data around several cord blood and cord tissue derived cell therapy products that had completed Phase 1/Phase 2 clinical trials. With this, Cryo-Cell is working to develop, as described further below, a pipeline of potential cord blood- and cord tissue-derived cellular products to be tested in Phase 2 and Phase 3 randomized, placebo-controlled clinical trials to further determine safety and efficacy of these products in babies with hypoxic ischemic encephalopathy, children with cerebral palsy, children with autism spectrum disorder and other conditions. Cryo-Cell’s cellular therapies with strong signals in Phase 3 clinical trials are expected to be moved through formal FDA approval pathways to Biologics License Applications (BLA) and commercialization.
- Based on the results of a Phase 1 trial at Duke, Cryo-Cell intends to conduct a Phase 2 randomized, placebo-controlled trial to test the safety and efficacy of cord tissue mesenchymal stem cells (MSCs) in newborns with hypoxic ischemic encephalopathy (HIE).
- Based on results in Phase 1 and 2 studies of cord blood infusions in children with cerebral palsy (CP) at Duke, Cryo-Cell may fund a Phase 3 randomized, placebo-controlled trial to confirm the efficacy of a cord blood infusion in children with CP which, if confirmed, would lead to a submission for FDA licensure (BLA).
- Cryo-Cell will support a follow-on randomized, placebo-controlled clinical trial to validate results in secondary and exploratory endpoints in a subset of patients on the Duke-ACT Phase 2 clinical trial, which investigated the benefits of cord blood infusions in children with autism. The new study is planned to improve upon the design and eligibility criteria to confirm the positive results of Duke-ACT’s secondary and exploratory outcomes.
David Portnoy, Chairman of the Board and Co-CEO, stated, “After several months of careful evaluation of the results from the early-stage clinical trials conducted by Duke University, Cryo-Cell believes that those results justify moving these cord blood and cord tissue cell therapy products to the next stage of clinical development.”
About Cryo-Cell International, Inc.
Founded in 1989, Cryo-Cell International, Inc. is the world’s first private cord blood bank. More than 500,000 parents from 87 countries have entrusted Cryo-Cell International with their baby’s cord blood and cord tissue stem cells. In addition to its private bank, Cryo-Cell International has a public banking program in partnership with Duke University. Cryo-Cell’s public bank has provided cord blood for more than 600 transplantations and operates cord blood donation sites across the U.S in prominent hospitals such as Cedars–Sinai Hospital in Los Angeles and Baptist Hospital in Miami. Cryo-Cell’s facility is FDA registered, cGMP-/cGTP-compliant and licensed in all states requiring licensure. Besides being AABB accredited as a cord blood facility, Cryo-Cell was also the first U.S. (for private use only) cord blood bank to receive FACT accreditation for adhering to the most stringent cord blood quality standards set by any internationally recognized, independent accrediting organization. Cryo-Cell owns the exclusive rights to PrepaCyte-CB, the industry’s most advanced cord blood processing technology.
Cryo-Cell’s mission is to provide the premier cord blood and cord tissue cryopreservation services and to develop, manufacture and administer cellular therapies to significantly improve the lives of patients worldwide. In February 2021, Cryo-Cell entered into a license agreement with Duke University that transformed Cryo-Cell into an autonomous, vertically integrated cellular therapy company.
For more information, please visit ir.cryo-cell.com.
Statements herein the terms “believe”, “intends”, “projects”, “anticipates”, “expects”, and similar expressions as used are intended to reflect “forward-looking statements” of the Company. The information contained herein is subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated in such forward-looking statements or paragraphs, many of which are outside the control of the Company. These uncertainties and other factors include the impact of the COVID-19 pandemic on our sales, operations and supply chain, the success of the Company’s global expansion initiatives and product diversification, the Company’s actual future ownership stake in future therapies emerging from its collaborative research partnerships, the success related to its IP portfolio, the Company’s future competitive position in stem cell innovation, future success of its core business and the competitive impact of public cord blood banking on the Company’s business, the success of the Company’s initiative to expand its core business units to include biopharmaceutical manufacturing and operating clinics, the uncertainty of profitability from its biopharmaceutical manufacturing and operating clinics, the Company’s ability to minimize future costs to the Company related to R&D initiatives and collaborations and the success of such initiatives and collaborations, the success and enforceability of the Company’s umbilical cord blood and cord tissue license agreements, together with the associated intellectual property and their ability to provide the Company with royalty fees, and those risks and uncertainties contained in risk factors described in documents the Company files from time to time with the Securities and Exchange Commission, including the most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K filed by the Company. The Company disclaims any obligations to subsequently revise any forward-looking statements to reflect events or circumstances after the date of such statements.
Released October 27, 2021