West Lafayette, IN – February 19, 2025 – On Target Laboratories is pleased to share it has been named a Gold Winner in the 2024 Best in Biz awards. The company’s product, CYTALUX® (pafolacianine) injection, was recognized in the “Most Innovative Product of the Year – Healthcare and Medical” category.
Best in Biz Awards, now in its 14th year, is the only independent business awards program judged each year by prominent editors and reporters from top-tier publications in North America. Each year has seen intense competition for the top honors, from public and private companies, representing all industries and regions in the U.S. and Canada, and ranging from Fortune 100 and the most iconic global brands to some of the most innovative start-ups and local favorites.“On behalf of the entire On Target team, we are honored and humbled that CYTALUX was named the most innovative healthcare and medical product of the year by the respected Best in Biz community,” said Bill Peters, President and CEO of On Target Laboratories. “Our goal to help improve the cancer battle is now a reality, and CYTALUX is the first and only targeted molecular imaging agent that illuminates lung and ovarian cancer in real time during surgery. We are eager to continue improving cancer surgery and the lives of thousands of people this year.”
Since the program’s inception in 2011, winners in Best in Biz Awards have been determined by independent judging panels assembled each year from some of the most respected national and local newspapers, TV and radio outlets, and business, consumer, technology and trade publications in North America.
About On Target Laboratories, Inc.
On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery. Their molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University’s Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, is comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.
CYTALUX, the Company’s first product, received FDA approval of a New Drug Application for ovarian cancer in November 2021 and a supplemental New Drug Application for lung cancer in December 2022. CYTALUX targets the folate receptors commonly found on many cancers, binds to the cancerous tissue, and illuminates under near-infrared light. A single dose of the agent is administered via intravenous infusion prior to surgery and assists surgeons in visually identifying additional cancerous tissue to be removed during the operation. For more information and to view full Prescribing Information visit www.ontargetlabs.com and www.cytalux.com.
INDICATION AND USAGE
CYTALUX® is an FDA approved optical imaging agent indicated as an adjunct for intraoperative identification of:
- Malignant lesions in adult patients with ovarian cancer.
- Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during administration of CYTALUX. Reactions typically occurred within 15 minutes of the start of infusion. CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. Treatment with antihistamines and/or anti-nausea medication may be used. If an adverse reaction occurs during administration, the infusion can be interrupted and resumed after treatment of the reaction.
Risk of Misinterpretation
Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung. Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, lungs, and inflamed tissue.
Embryo-Fetal Toxicity
Based on its mechanism of action, CYTALUX may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating CYTALUX treatment.
Risk of Pafolacianine Aggregation and Infusion Reactions
Use of the incorrect diluent to prepare the CYTALUX infusion solution can cause the aggregation of pafolacianine; aggregation may induce infusion reactions such as nausea, vomiting, abdominal pain or rash. Use only 5% Dextrose Injection to prepare the CYTALUX infusion solution. Do not use other diluents.
DRUG INTERACTIONS
Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors and could reduce the detection of lesions with CYTALUX. Avoid administration of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX.
ADVERSE REACTIONS
The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N = 100 and N = 112) in patients with known or suspected cancer in the lung. A total of 406 patients received 0.025 mg/kg of CYTALUX via intravenous administration.
Adverse reactions that occurred in ≥ 1% of patients were: nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%), hypersensitivity (2%), elevation in blood pressure (1%), dyspepsia (1%), and chest discomfort (1%). Adverse reactions occurred during the administration of CYTALUX in 17% of patients.
See full Prescribing Information to learn more.