On Target Laboratories Completes ELUCIDATE Phase 3 Clinical Trial Investigating the Use of CYTALUX™ (pafolacianine) injection in Cancer in the Lung

WEST LAFAYETTE, Ind., Jan. 13, 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 the completion of the Phase 3, randomized, multi-center, single dose, open-label ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) Trial, which investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected cancer in the lung.  

The study (NCT04241315) assessed the efficacy of CYTALUX and near-infrared imaging (NIR) to intraoperatively identify pulmonary nodules and detect positive margins.  It also evaluated the safety and tolerability of single intravenous doses of CYTALUX. The trial successfully achieved its primary endpoint and full results will be shared in the future.

"Lung cancer is the number one cancer killer of men and women globally," said Inderpal (Netu) Sarkaria, MD, MBA, FACS Associate Professor of Cardiothoracic Surgery and Chair in Minimally Invasive Thoracic Surgery and Director of Thoracic Robotic Surgery at UPMC and ELUCIDATE trial investigator. "There is opportunity for emerging technologies to enhance our ability to find and remove cancer during surgery to improve the lives of lung cancer patients."

CYTALUX was approved by FDA on November 29, 2021 for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.  CYTALUX is the first targeted molecular imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV prior to surgery, binds to folate receptors that are overexpressed in most epithelial ovarian cancersⁱ and illuminates intraoperatively under near-infrared light.

"ELUCIDATE was completed ahead of schedule, which was a monumental achievement during a pandemic," said Chris Barys, President and Chief Executive Officer of On Target. "We are grateful to the trial patients, the Investigators and their teams who helped us move yet another step closer to bringing CYTALUX to more patients fighting cancer."

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.

About On Target Laboratories, Inc.

On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery so cancerous tissue can be removed more completely. 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.

Click here to see full Prescribing Information

Disclosures

Dr. Sarkaria has received compensation from On Target Laboratories for duties as a member of the independent trial steering committee.

ⁱ Kalli KR, Oberg AL, Keeney GL, et al. Folate receptor alpha as a tumor target in epithelial ovarian cancer. Gynecologic Oncology. 2008;108(3):619-626.

SOURCE On Target Laboratories, Inc.