CorMedix Inc. Announces Signing of an Agreement with POETIC (Pediatric Oncology Experimental Therapeutics Investigators Consortium), to Develop CRMD-005, a Proprietary Formulation of Taurolidine, for Rare Orphan Pediatric Tumors
Bedminster, NJ – September 15, 2016 – CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases, and POETIC, The Pediatric Oncology Experimental Therapeutics Investigators Consortium, a group of 10 top tier academic medical centers, developing new promising pediatric cancer therapies are pleased to announce a joint development agreement focused on the oncologic applications of CRMD-005, a proprietary formulation of Taurolidine, as a potential treatment for rare orphan pediatric tumors, including neuroblastoma and osteosarcoma.
Randy Milby CEO of CorMedix and Tanya Trippett, M.D. Co-Founder and Executive Director of POETIC announced the signing of an agreement to develop novel therapies for rare orphan pediatric tumors, including neuroblastoma and osteosarcoma. This effort will start with pre-clinical studies, gene mapping, and cellular gene network analysis of the anti-cancer mechanisms of Taurolidine in vitro and in animal models.
The program will involve collaboration with a number of NCI Cancer Centers that are part of the POETIC group including Memorial Sloan Kettering Cancer Center (MSK), Weill Cornell Medical Center, Alberta Children’s Hospital, and other top tier cancer centers of excellence.
Pre-clinical development will be led by Dr. Aru Narendran, Alberta Children’s Hospital in Canada. Dr. Narendran offered his perspective, “We are excited to pursue further defining Taurolidine’s potential role in pediatric malignancies, especially in refractory and resistant cell lines as well as define which drugs make sense to best combine with Taurolidine for planning future clinical studies.
“Taurolidine’s mechanism of action involves a variety of important steps which include the induction of cellular apoptosis, the inhibition of angiogenesis, the down regulation of pro-inflammatory cytokines, as well as decreasing tumor adherence and an enhancement of immune mediated anti-tumor activity. Our goals are to better elucidate Taurolidine’s mechanism effects and leverage its history of safety to maximize its anti-neoplastic potential in an intelligent and efficient manner.”
“Our overall aim is to identify pathways and mechanisms by which Taurolidine exerts its anti-tumor effects in pediatric oncology at the cellular, animal, and ultimately human level.” explained Dr. Tanya Trippett, MD. Randy Milby continued, “CorMedix is pleased to advance jointly with the POETIC Consortium a comprehensive Protocol for the Evaluation of Taurolidine in Preclinical Studies for Refractory Pediatric Malignancies”.
The Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC) was founded in February 2003 by Dr. Lia Gore at the University of Colorado Cancer Center and Dr. Tanya Trippett. POETIC is composed of ten large academic medical centers in North America with a major emphasis on comprehensive cancer care and research that provide the collaborative and research strength needed to complete intensive phase I and II studies. Each of the institutions is uniquely suited to complete early studies in the pediatric and adolescent populations. POETIC’s assets include membership in NCI-designated Comprehensive Cancer Centers, on-site NIH- funded pediatric and/or general clinical translational research centers (CTRCs/CTSAs), and active collaborations with developmental therapeutics programs for adults at a majority of its member institutions. The availability of strong basic science and translational research programs at the institutions allows focus on the development and evaluation of new therapeutic strategies for patients with cancer and related disorders. POETIC’s pediatric oncology studies focus on the biologic basis for anti-cancer therapy, and in particular, attempt to explore and evaluate new agents and novel combinations of therapies early in clinical development.
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical study in patients undergoing chronic hemodialysis via a central venous catheter. The company is planning to conduct its second Phase 3 study in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, contributing to potentially accelerated FDA review and up to 10 years of market exclusivity upon potential U.S. approval. It is already a CE Marked product in Europe and other territories. CorMedix is also seeking to unlock additional value for its taurolidine-based technology by establishing collaborative partnerships in oncology and medical device applications. For more information visit: www.cormedix.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: CorMedix’s ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs, including the collaboration with POETIC; the results of studies regarding Neutrolin® conducted by us and others; the cost, timing and results of the planned Phase 3 trials for Neutrolin® in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix’s product candidates, including marketing of Neutrolin in countries other than Europe; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; the risks associated with the launch of Neutrolin in new markets; CorMedix’s ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources; the outcome of clinical trials of CorMedix’s product candidates and whether they demonstrate these candidates’ safety and effectiveness; CorMedix’s ability to identify and enter into strategic transactions; CorMedix’s dependence on its collaborations and its license relationships; achieving milestones under CorMedix’s collaborations; CorMedix’s dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.