Category: Uncategorized

Empowering Patients Through Innovative Solutions in Cancer Care

Posted on August 31, 2026 by - Uncategorized

 

At Curadel Pharma, the fight against cancer is being redefined through groundbreaking scientific developments designed to transform how we detect, diagnose, and treat cancer.

Through our Audacious Alpha™ platform, Curadel is spotlighting a new era of cancer care focused on high-precision, next-generation solutions. From targeted alpha therapies that deliver potent radiation directly to tumor cells while minimizing damage to healthy tissue to highly precise imaging and diagnostic tools, Curadel’s advances aim to deliver more effective and durable treatments for patients facing challenging diagnoses.

Central to Curadel’s mission as a company is a deep commitment to public education and transparency. We believe that access to cutting-edge science should not be confined to research labs or medical journals, but should be freely available through public channels, including our website and social content. By shedding light on advances in precision diagnostic and therapeutic modalities, we bridge the gap between complex biomedical innovation and the public domain.

Ultimately, Curadel provides these educational resources to empower patients, caregivers, and families with the knowledge needed to navigate their care journeys. By demystifying the science behind emerging oncological technologies, our Audacious Alpha™ platform aims to enable individuals to better understand their options, encouraging meaningful, well-informed discussions with healthcare providers when making critical health and treatment decisions.

FDA and EMA Grant Orphan Drug Designation for Curadel’s CPI-008, a Targeted Zwitterionic Imaging Drug for Pancreatic Cancer

Posted on January 7, 2026 by - Uncategorized

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

 

BONITA SPRINGS, FL – January 7, 2026 – 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.

Curadel Pharma Initiates Phase 3 Trial of ZW800-1, a First-in-class Zwitterionic Drug for Optical Surgical Navigation

Posted on March 12, 2025 by - Uncategorized

Trial initiation follows completion of successful Phase 2 cohort, which met primary endpoints

 

BOSTON – March 12, 2025 – Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and drugs for optical surgical navigation, announced today that it has initiated the Phase 3 portion of its pivotal study evaluating the investigational ZW800-1 (nizaracianine triflutate) to highlight the ureter during abdominopelvic surgery.

“As the first zwitterionic near infrared (NIR) fluorophore, ZW800-1 represents an important advancement in enhanced surgical imaging. The first portion of this pivotal study found that strong visual contrast enhancement of the ureters provided apparent benefit to both patient and surgeon without compromising safety,” said John V. Frangioni, M.D., Ph.D., Curadel founder and CEO. “With confidence in our target dose, we look forward to expanding the trial to eight sites worldwide with more than 50 surgeons. Our goal is to demonstrate for the first time that surgeons can assess ureter anatomy, function, and intactness in real time during open, laparoscopic, and robotic surgeries.”

ZW800-1 is a novel small molecule drug with a unique zwitterionic chemical structure that prevents the drug from binding non-specifically to tissues and organs after injection, and facilitates its elimination by the kidneys into urine. Once in urine, the drug creates visual contrast in the ureters that would otherwise not exist, and using a near-infrared (NIR) camera, surgeons can find the ureters and assess their function in real-time.

The Phase 3 portion of the trial has been approved for enrollment based on positive Phase 2 study findings. During Phase 2, ZW800-1 met its composite primary endpoint of a strong signal-to-background ratio and visualization of the required length of ureter(s), all with a favorable safety profile. There were no severe adverse events associated with the study drug. An optimal dose of only 2.5 mg will be utilized in the Phase 3 cohort, which expects to enroll more than 300 participants worldwide. More information on the trial can be found at clinicaltrials.gov (NCT06101745).

Curadel Pharma secures $10.5M in series A2 funding to propel novel Zwitterionic Radiotherapy Platform

Posted on January 13, 2025 by - Uncategorized

BOSTON – March 2025 – Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and imaging drugs, announced completion of a Series A2 funding round, securing $10.5M to advance early stage development for its lead programs.

“We are building a strong body of evidence that our zwitterionic platform has broad applicability in the oncology landscape and the funding we’ve attracted from strong investment partners demonstrates the enthusiasm for this opportunity,” said John Brimacombe, Curadel President. “Building upon strong proof of concept data in imaging drugs, we are now focused on applying the power of zwitterionicity to deliver profound improvements in the outcomes associated with TATs, initially for rare cancers.”

The most recent funding aims to support critical validating steps for the platform and the lead candidate CPI-003, including proof of synthesis studies, preclinical development and regulatory preparations. Work continues on ZW800-1, Curadel’s imaging drug, which is under evaluation in a pivotal trial led by a Tier 1 medical device company.

Curadel Pharma initiates Phase 2 Portion of the Pivotal trial of ZW800-1, a first-in-class Zwitterionic Ureter imaging surgical drug

Posted on January 13, 2025 by - Uncategorized

BOSTON – July 2024 – Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and imaging drugs, announced the initiation of a pivotal study evaluating its investigational imaging-guided drug ZW800-1 (nizaracianine triflutate) to highlight the ureter during abdominopelvic surgery.

“A major unsolved problem in surgical imaging is anatomical enhancement of the ureters. Damage to the ureters is a serious unintended complication of abdominopelvic surgery, leading to high patient morbidity and cost. Visual contrast enhancement of the ureters can provide enormous benefit to both patient and surgeon,” said John Frangioni, MD, PhD, Curadel founder and CEO. “ZW800-1 is the world’s first zwitterionic near infrared (NIR) fluorophore, with a strong and growing body of data supporting its safety and efficacy to enhance outcomes in this critical setting.”

ZW800-1 is a novel small molecule drug with a unique zwitterionic chemical structure that prevents the drug from binding non-specifically to tissues and organs after injection and facilitates its excretion by the kidneys into urine. Once in urine, the drug creates visual contrast in the ureters that would otherwise not exist, and using a near-infrared (NIR) camera, surgeons can find the ureters and assess their function in real-time. ZW800-1 has been out-licensed to a Tier 1 medical device company.

The multi-center, multi-national TRIPHASE trial will assess ZW800-1 to aid visualization of the ureters throughout surgery, and in so doing, help lower the risk of injury and improve patient outcomes. The first phase of the trial will determine the optimal dose. Patients enrolled in the second phase will be randomly assigned to the selected dose of the drug or placebo, and those in the third phase will all receive drug at the target dose. More information on the trial can be found at clinicaltrials.gov (NCT06101745).

This trial is based on the positive results of a Phase 1/2 trial, which demonstrated its utility in visualizing and assessing ureter structure and function during laparoscopic lower abdominal surgery within 10 min after IV administration, without altering the look of the surgical field. Those study results were published in Nature Communications in 2019.