On Target Laboratories, Inc. Announces Presentation of the Results from the ELUCIDATE Phase 3 Trial for CYTALUX™ (pafolacianine) injection for Intraoperative Molecular Imaging of Lung Cancer

WEST LAFAYETTE, Ind., May 11, 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 that results from the randomized, multi-center Phase 3 ELUCIDATE Trial will be presented at the 102^nd American Association for Thoracic Surgery (AATS) annual meeting, May 14-17, 2022 in Boston.

The late-breaking presentation will highlight outcomes of the pivotal ELUCIDATE Trial, which assessed the efficacy of CYTALUX and near-infrared imaging (NIR) to intraoperatively identify pulmonary nodules and evaluate resection margins. On Target previously announced the trial successfully achieved its primary endpoint. The research findings will be presented by Sunil Singhal, MD, Director of the Center for Precision Surgery, Abramson Cancer Center at the University of Pennsylvania, and national principal investigator of the Phase 3 clinical trial, on Tuesday, May 17 at 9:30 am ET in Room 311. This trial was performed at 11 other centers around the country including MD Anderson, Mayo Clinic, Cleveland Clinic, University of Virginia, University of Michigan, University of Pittsburgh, Swedish Cancer Institute, Stamford Hospital, University of Iowa, Allegheny Hospital, and Beth Israel Deaconess Hospital.

"These positive Phase 3 trial results show that when surgeons used a targeted fluorescent dye to bind to cancer cells to make them glow, intraoperative molecular imaging helps better identify a patient's tumors for resection," said Singhal. "The ability to visualize cancer cells beyond what can be seen and felt with today's standard of care is an important step toward greater precision during surgery."

"We are proud of the breadth of studies being presented at the AATS 102^nd Annual Meeting, highlighting the significant potential we see for CYTALUX to aid in real-time, intra-procedural treatment decisions," said Chris Barys, President and Chief Executive Officer of On Target. "Our commitment to research will help us continue advancing our mission to illuminate cancer intraoperatively to reduce the challenges with identifying cancerous tissue for removal."

Additional presentations at AATS related to CYTALUX include:

• "Single-Cell Optical Detection of Lung Cancer in Real Time by Targeted Near-Infrared Confocal Laser Endomicroscopy Imaging," Gregory Kennedy, MD, PhD, University of Pennsylvania – Sunday, May 15, 12:30 pm ET, Room 309
  
  
• "Transbronchial Lung Tumor Localization with Folate Receptor-Targeted Near-Infrared Molecular Imaging: A Proof-of-Concept Study in Animal Models," Tsukasa Ishiwata, MD, PhD, University of Toronto –Tuesday, May 17, 8:45 am ET, Room 311

For more information about On Target, visit booth 1301 during the meeting or www.ontargetlabs.com. To schedule a meeting with On Target at AATS 2022, email [email protected]. Information about AATS 2022 can be found at www.aats.org.

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. 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 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

SOURCE On Target Laboratories, Inc.