On Target Laboratories Announces Publication in Journal of Clinical Oncology of Results from Phase 3 Trial of CYTALUX® (pafolacianine) Injection for Intraoperative Imaging of Ovarian Cancer

WEST LAFAYETTE, Ind., Sept. 12, 2022 /PRNewswire/ -- On Target Laboratories, Inc., a privately-held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, today announced publication of results from the Phase 3 006 Study of CYTALUX (pafolacianine) injection for intraoperative imaging of folate receptor positive ovarian cancer in the peer-reviewed Journal of Clinical Oncology.

The research article reports that use of CYTALUX during ovarian cancer surgery demonstrated identification of additional ovarian cancer that was not identified with conventional means and not otherwise planned for resection. 150 patients in the safety analysis set received a single infusion of CYTALUX, resulting in 109 patients with folate receptor positive ovarian cancer comprising the full analysis set for efficacy. In 33% of patients*, near-infrared imaging with CYTALUX identified additional lesions which would have been left behind (P < 0.001, 95% CI [0.243, 0.427]). The rate was higher, at 39.7%, among patients who underwent interval debulking surgery (95% CI [0.270, 0.534]).  

"This pivotal study indicates that CYTALUX may offer an important real-time adjunct to current surgical approaches for ovarian cancer," said Chris Barys, President and Chief Executive Officer of On Target. "We are grateful to the study participants and investigators for their important role in this research and are committed to continuing to pioneer the use and study of intraoperative molecular imaging to increase detection of malignant lesions during surgery."

"There are many limitations to current operative approaches of visual inspection and palpation, and I am encouraged that, in this clinical trial, near-infrared imaging with CYTALUX identified additional lesions in 33% of participants which would have been left behind," said Janos L. Tanyi, MD, PhD, an associate professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and principal investigator of the Phase 3 trial. "These results further the evidence that intraoperative molecular imaging may help surgeons achieve complete surgical resection of cancer."

* N=36 out of 109 folate receptor positive ovarian cancer patients. CYTALUX USPI describes the proportion of patients in which CYTALUX identified additional lesions in the "intent-to-image set" regardless of ovarian cancer status (N=36 out of 134, 27%)

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, are 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 for ovarian cancer in November 2021. CYTALUX targets folate receptors commonly found on many cancers, such as ovarian cancer. A single dose of the agent is administered via intravenous infusion prior to surgery to help the surgeon identify additional malignant tissue during the operation using a near-infrared imaging system. For more information visit www.ontargetlabs.com and  www.cytalux.com.

CYTALUX Indication

CYTALUX is an FDA-approved optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.

Important Safety Information

Infusion-Related Reactions 
Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, and itching were reported during the administration of CYTALUX. Your doctor may treat you with antihistamines and/or anti-nausea medication.

Pregnancy
CYTALUX may cause fetal harm when administered to a pregnant woman.  There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Contact your healthcare provider with a known or suspected pregnancy.

Folate Supplement Usage
Folic acid may reduce the detection of cancerous tissue with CYTALUX. Patients should stop taking folate, folic acid, or folate-containing supplements 48 hours before administration of CYTALUX.

Risk of Misinterpretation
Errors may occur with the use of CYTALUX. Sometimes cells may light up even if they are not cancerous or those that are cancerous may not light up. Also, cancerous or non-cancerous cells from other areas may light up, such as areas of the bowel, kidneys, lymph nodes, and inflamed tissue.

Adverse Reactions
The most common side effects of CYTALUX reported in clinical trials were nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, itching, and allergic reaction during administration or infusion.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CYTALUX. For more information, ask your healthcare provider.

Call your doctor for medical advice about side effects. You may report side effects to On Target Laboratories at 1-844-434-9333 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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SOURCE On Target Laboratories, Inc.