Navigation Links
FDA Clears Cellectar's IND Application for Lead Drug Candidate

(131)I-CLR1404 to Enter Clinical Trials

MADISON, Wis., March 3 /PRNewswire/ -- Cellectar, Inc., a privately held radiopharmaceuticals company that designs and develops products to detect, treat and monitor human cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its (131)I-CLR1404 drug candidate for testing in patients with advanced solid malignancies. The company expects to begin phase I clinical studies in the second quarter of 2009.

The first phase I study will enroll up to 9 patients and will include drug dosimetry calculations and biodistribution assessments. The second phase I study will be a dose escalation study evaluating the Maximum Tolerated Dose (MTD) of (131)I-CLR1404 in patients with advanced solid malignancies; both studies will be performed at four leading U.S. medical centers.

Cellectar's President and CEO, Bill Clarke, M.D., commented, "We are extremely pleased to have received FDA clearance allowing us to advance our lead product candidate into human clinical studies. Further, we are hopeful that this novel anti-cancer compound, selectively retained by cancer cells, may provide benefit to solid tumor patients with few therapeutic options."

About (131)I-CLR1404

Cellectar's (131)I-CLR1404 is a small-molecule, phospholipid ether analog that combines lipid-like properties with a cancer therapeutic beta-emitting radioisotope. Cellectar believes that this compound will benefit individuals with cancer due to its selective retention and accumulation in malignant cells versus nonmalignant cells. Preclinical animal studies demonstrated that (131)I-CLR1404 significantly slowed the growth of malignant solid tumors and resulted in improved survival. Non-radiolabeled CLR1404 proved safe at doses greater than 1000x the anticipated human dose.

About Cellectar

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. For further information, please visit Cellectar's website at

SOURCE Cellectar, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Global Gene Map Clears New Milestone
2. FDA Clears MDN-CGS(R) Intravenous Insulin Dosing Software
3. American Medical Association Clears Path for Adenoviral Conjunctivitis - Pink Eye - Detector
4. Congress Clears the Way for National CPR and AED Awareness Week
5. FDA Clears Cellsearch(TM) Circulating Tumor Cell Test for Monitoring Metastatic Prostate Cancer Patients
6. ClearScript Offers Innovative Medication Therapy Management Program to Employee Health Plans
7. Alzheimers vaccine clears plaque but has little effect on learning and memory impairment
8. Genetic Information Nondiscrimination Act clears Senate
9. Dutch Authorize Manufacture of Vaccinogens New Cancer Vaccine; License Clears Path to European Production, Final FDA Trial
10. FDA Clears NeuroStar(R) TMS Therapy for the Treatment of Depression
11. FDA Clears the DPL (Deep Penetrating Light) Therapy System for Over-the-Counter - Home Use
Post Your Comments:
(Date:10/12/2017)... ... ... IsoComforter, Inc. ( ), one of the Nation’s premier ... of the shoulder pad. The shoulder pad provides optimal support and full contact ... using cold therapy. By utilizing ice and water that is circulated from an insulated ...
(Date:10/12/2017)... ... 2017 , ... Information about the technology: , Otomagnetics has ... prevention of a major side effect of chemotherapy in children. Cisplatin and carboplatin ... cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. Hearing ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... for the 49th Congress of the International Society of Paediatric Oncology (SIOP) ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. ...
(Date:10/12/2017)... ... October 12, 2017 , ... Health ... interactive health literacy software tool, and the Cancer Patient Education Network (CPEN), an ... education, today announce a new strategic alliance. , As CPEN’s strategic partner, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Farm ... California Berkeley, and other leading institutions in announcing the launch of the ... change the way animals are raised for food. , Founding members of the ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... , Sept. 22, 2017 AVACEN Medical ... device is now successfully helping those with the widespread ... Fibromyalgia diagnosed Amanda in Essex, England ... and washing my hair, experiencing no sleep at all, ... painful spasm… I cannot recommend [the AVACEN 100] enough, ...
(Date:9/19/2017)... 2017   ZirMed Inc ., a recognized leader in ... it has been ranked #1 by its users for the ... 2017 User Survey. ZirMed was recognized as the top-ranked end-to-end ... medical centers over 200 beds and holds one of the ... survey history. ...
(Date:9/18/2017)... Sept. 18, 2017 EpiVax, Inc. ... bioinformatics and immune engineering, today announced a ... A (H7N9) vaccine. ... seasonal influenza and presents a challenge for ... exposure to be effective. Using state-of-the-art bioinformatics and ...
Breaking Medicine Technology: