US and EU regulatory designations provide critical development resources to advance novel tumor detection technology

Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and imaging drugs, announced today that CPI-008 (cRGD-ZW800-1), a novel integrin-targeted, zwitterionic imaging drug for margin detection of pancreatic cancer during surgery, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

“Receiving orphan designation from both the FDA and the EMA is a profoundly important milestone for Curadel, granting us valuable incentives to fuel our development efforts,” said John V. Frangioni, MD, PhD, Curadel founder and CEO. “As a pioneering company working to introduce significant advances in surgical imaging, the efficiencies of fee exemptions, credits, along with the potential for market exclusivity are vital tools to help us smartly deploy our resources and focus on delivering value to the surgical community.”

In the U.S., FDA grants ODD to therapeutic candidates for conditions affecting fewer than 200,000 people in the U.S. This designation provides incentives to advance clinical development including exemption from user fees, tax credits for qualified clinical trials, and potential for up to seven years of U.S. market exclusivity if the product is approved for its designated indication. Similarly, EMA's designation includes incentives including protocol assistance, reduced regulatory fees, and potential for early access conditional approvals, as well as market exclusivity up to 10 years if approved.

Pancreatic cancer remains one of the most challenging cancers to treat, and current imaging tools are not fully effective in helping to identify the full extent of cancerous cells to allow for full removal during surgical procedures. By enhancing surgeons’ ability to accurately visualize cancerous cells, Curadel’s technology could become an important asset in the surgical suite to optimize outcomes not only for pancreatic cancer patients, but potentially for other tumor types as well.

CPI-008 has demonstrated strong imaging capabilities in investigator-initiated Phase 2 studies in multiple cancers including pancreatic cancer, head and neck cancer, and colorectal cancer. As part of its strategic pipeline curation, Curadel is evaluating out-licensing opportunities for the program, offering a highly differentiated technology that potential partners can leverage to expand leadership in the competitive imaging market.

About Curadel Pharma

Curadel Pharma, based in Bonita Springs, FL, is an audacious innovator aiming to prevent tumor resistance via disruptive zwitterionic radiopharma technology. Its novel, pan-tumor platform prevents tumor regrowth and resistance while eliminating collateral damage to healthy tissues. Curadel’s lead radiopharmaceutical candidate, CPI-003, represents a potential best-in-class zwitterionic targeted alpha therapy (TAT) initially focused on the treatment of challenging rare cancers. The company is also developing image-guided surgical drugs as well as zwitterionic MRI contrast agents. Its late-stage drug for ureter imaging is the subject of an exclusive distribution agreement with a Tier 1 medical device company and is currently under evaluation in a pivotal trial. For more information, visit www.curadelpharma.com or follow us on LinkedIn.

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