Radiopharmaceutical production facility to support clinical development for lead drug candidate and other molecules
MADISON, Wis., Aug. 18 /PRNewswire/ — Cellectar, Inc., a privately-held radiopharmaceutical company that designs, develops and manufactures products to detect, treat and monitor human cancers, today announced that it has completed commissioning its in-house manufacturing capability to meet clinical trial needs in compliance with Good Manufacturing Practice (GMP) requirements. This capability will allow Cellectar to initiate and complete its clinical trials while remaining independently able to develop and manufacture new radiopharmaceuticals beyond its lead candidate, CLR1404. With this unique capability in place, Cellectar is now actively looking to expand its portfolio both with internal candidates and through potential in-licensing opportunities.
“We are extremely gratified to have achieved GMP compliance in our radiopharmaceutical manufacturing facility because it takes us one step closer toward clinical trials with our lead drug candidate, CLR1404,” commented Neal Sandy, Chief Operating Officer at Cellectar. “Our manufacturing technology and custom-designed building, provide the flexibility and opportunity for our growing company to supply the radiopharmaceuticals needed to support our clinical program and to continue the development of additional molecules.”
Cellectar’s lead drug candidate, CLR1404, is a phospholipid ether (PLE) analog radiolabeled with iodine-131, a radioactive isotope commonly used to treat cancer. In pre-clinical evaluations, CLR1404 has shown the ability to carry the potent isotope inside malignant cells and destroy them without adversely affecting healthy tissues. Human trials will begin later this year following submission and FDA review of Cellectar’s Investigational New Drug (IND) application.
Cellectar’s initial clinical trial will focus on assessing safety and appropriate dosing in the treatment of a variety of solid tumors.
Cellectar, Inc. is a radiopharmaceutical company that designs, develops and manufactures products to detect, treat and monitor a wide variety of human cancers. Cellectar’s novel product candidates combine lipid-like molecules, phospholipid ethers (PLEs) analogs, with radioisotopes that can either image or destroy malignant cells. Cellectar’s products’ unique mechanism of action is based on their accumulation and selective retention in malignant tumors and not in normal cells. The company’s operations are based in Madison, WI. Cellectar has previously raised approximately $22.0 million from angel and venture capital investors; including Continuum Investment Partners and Venture Investors, LLC. For further information about Cellectar, visit the company’s website at www.cellectar.com.
Source: Cellectar, Inc.