Navigation Links
FDA Clears Cellectar's IND Application for Lead Drug Candidate
Date:3/3/2009

(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 www.Cellectar.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
(Date:6/24/2016)... ... 24, 2016 , ... Dr. Amanda Cheng, an orthodontist ... has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be used ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain ... for a minimum wage raise to $12 an hour by 2020 and then adjusting it ... the lost value of the minimum wage, assure the wage floor does not erode again, ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® ... Group (TGIG), has initiated cultivation and processing operations at its production facility, and ... Nevada. , Puradigm is the manufacturer of a complete system of proactive air ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) ... Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated testing ... With this clearance, Roche is the first IVD company ... for sepsis risk assessment and management. PCT ... PCT levels in blood can aid clinicians in assessing ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... 52" report to their offering. ... creates a favourable commercial environment for MedImmune to enter. The ... that will serve to drive considerable growth for effective anti-influenza ... to cap sales considerably, but development is still in its ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 ... Tomorrow,s Leaders Scholarship is any indication, the future is ... online at www.diabetesscholars.org by the Diabetes Scholars ... in the way of academic and community service excellence. ... program since 2012, and continues to advocate for people ...
Breaking Medicine Technology: