Breaking News
March 20, 2019 - Leaky valve repair improves quality of life in heart failure patients
March 20, 2019 - Diattenuation Imaging offers structural information of difficult to access brain regions
March 20, 2019 - Early sports specialization linked to increased injury rates during athletic career
March 20, 2019 - Study brings clarity about milk intake for children with Duarte galactosemia
March 20, 2019 - Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
March 20, 2019 - Maternal smoking during pregnancy increases risk of ADHD among offspring up to three-fold
March 20, 2019 - Pioneering pediatric kidney transplant surgeon Oscar Salvatierra dies at 83 | News Center
March 20, 2019 - F.D.A. Approves First Drug for Postpartum Depression
March 20, 2019 - TB remains a major public health challenge in the European region
March 20, 2019 - Most pills contain common allergens, warn experts
March 20, 2019 - Researchers discover previously unknown mechanism by which cells can sense oxygen
March 20, 2019 - World’s leading source of data on diagnosis, treatments for aortic dissection
March 20, 2019 - Breast cancer relapse predictor may soon be a reality
March 20, 2019 - Researchers identify origin of chronic pain in humans
March 20, 2019 - Two-drug combinations containing calcium channel blocker significantly lowers BP
March 20, 2019 - King’s scientists to monitor air quality exposure of 250 children
March 20, 2019 - Preventative cardioverter defibrillator implantation is of little benefit to kidney dialysis patients
March 20, 2019 - Merck to collaborate with GenScript for plasmid and virus manufacturing in China
March 20, 2019 - FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression
March 20, 2019 - Study examines long-term opioid use in patients with severe osteoarthritis
March 20, 2019 - Retired Stanford professor Edward Rubenstein, pioneer in intensive care medicine, dies at 94 | News Center
March 20, 2019 - Aaron Diamond AIDS Research Center to Join Columbia University
March 20, 2019 - Call for halt to human gene editing and designer babies experiments
March 20, 2019 - Study illuminates how hot spots of genetic variation evolved in the human genome
March 20, 2019 - Roundworm study suggests alternatives for treatment of schizophrenia
March 20, 2019 - Sphingotec reports new applications of bio-ADM at 39th ISICEM
March 20, 2019 - Preventing falls through free community-based screenings for older adults
March 20, 2019 - AAOS: Supplement Use Low in Patients With Osteoporosis, Hip Fracture
March 20, 2019 - Does intensive blood pressure control reduce dementia?
March 20, 2019 - Nut consumption could be key to better cognitive health in older people
March 20, 2019 - Drinking hot tea associated with increased risk of esophageal cancer
March 20, 2019 - Androgen receptor plays vital role in regulating multiple mitochondrial processes
March 20, 2019 - NIH announces funding boost for Detroit Cardiovascular Training Program
March 20, 2019 - Study reveals another surgical option for patients with irreparable rotator cuff tears
March 20, 2019 - New robot-guided video game may be effective and low-cost solution for caregivers
March 20, 2019 - Heart Attacks Fall By One-Third Among Older Americans
March 20, 2019 - Data sharing uncovers five new risk genes for Alzheimer’s disease
March 20, 2019 - Does It Make Sense To Delay Children’s Vaccines?
March 20, 2019 - Lack of health insurance may increase Aging immigrants’ risk for cardiovascular disease
March 20, 2019 - Piece of puzzle unlocked in what drives alcohol addiction
March 20, 2019 - Researchers investigate whether Zika reservoirs are found in the Americas
March 20, 2019 - Compounds found in coffee may inhibit growth of prostate cancer
March 20, 2019 - Lab Innovations returns to the NEC on 30 & 31 October 2019
March 20, 2019 - How genes affect tobacco and alcohol use
March 20, 2019 - Osteoarthritis and rheumatoid arthritis have similar impacts on patients
March 20, 2019 - Individuals with infection history have higher risk of developing Sjögren’s syndrome
March 20, 2019 - Nursing home residents benefit from individualized multi-component exercise program
March 20, 2019 - Plant cellulose bone implants are “viable” option to support new bone growth, study finds
March 20, 2019 - Older people living in retirement communities benefit from improved health
March 20, 2019 - UTSA professor helps train first responders to detect prescription opioid overdoses
March 20, 2019 - Biohaven’s Verdiperstat Receives Orphan Drug Designation From FDA For Multiple System Atrophy
March 20, 2019 - Smoking may limit body’s ability to fight dangerous form of skin cancer
March 20, 2019 - Researchers receive $9.7-million grant to develop new hearing-loss treatments for deaf
March 20, 2019 - TGen and ABL sign agreement to distribute new TB test technology
March 20, 2019 - UCD researchers lead development of new urine test to detect prostate cancer
March 20, 2019 - Miniature brains that can move muscles, grown in the lab
March 20, 2019 - Servier and Oncodesign announce research and drug development partnership
March 20, 2019 - FDA warns marketer of unapproved products claiming to treat addiction, chronic pain
March 20, 2019 - TB Medicine Pretomanid Enters Regulatory Review Process in the United States
March 20, 2019 - Breastfeeding can erase effects of prenatal violence for newborns
March 20, 2019 - Tens of Thousands of Heart Patients May Not Need Open-Heart Surgery
March 20, 2019 - Space worries – shingles affecting astronauts says NASA
March 20, 2019 - Study shows how AI can improve physicians’ diagnostic accuracy
March 20, 2019 - Dolomite Bio launches new scRNA-Seq Reagent Kit at AGBT 2019
March 20, 2019 - World’s oldest semen viable for artificial insemination
March 20, 2019 - FDA Approves Zulresso (brexanolone) for the Treatment of Post-Partum Depression
March 19, 2019 - How it manipulates us to tribalism
March 19, 2019 - How can doctors encourage patients to adopt healthier behaviors?
March 19, 2019 - Meet Hal: He's One Sick Robot
March 19, 2019 - Blood test and mathematical model can estimate preterm birth rate in low-resource countries
March 19, 2019 - TAVR procedure safe in patients with unusual valve anatomy
March 19, 2019 - Proteins in the eye may be potential source for cost-effective test to predict Alzheimer’s disease
March 19, 2019 - Opioid Prescriptions Dropped for New Users From 2012 to 2017
March 19, 2019 - New method may better predict the best treatment for burn wounds
March 19, 2019 - “Asian” isn’t specific enough for health data, research suggests
March 19, 2019 - ColumbiaDoctors Presents Honors for Outstanding Commitment to Patient Safety
March 19, 2019 - Innovative model identifies primate species with potential to transmit Zika in the Americas
March 19, 2019 - One-off surgery could offer hope to patients with high blood pressure
March 19, 2019 - Many pet owners interested in feeding their pets with plant-based diet
March 19, 2019 - How to Protect Your Kids From Drowning
Cellectar’s CLR 131 Receives FDA Orphan Drug Designation for Treatment of Ewing’s Sarcoma

Cellectar’s CLR 131 Receives FDA Orphan Drug Designation for Treatment of Ewing’s Sarcoma

image_pdfDownload PDFimage_print

MADISON, Wis., July 09, 2018 (GLOBE NEWSWIRE) — Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131, the company’s lead Phospholipid Drug Conjugate™ (PDC) product candidate, for the treatment of Ewing’s sarcoma, a rare pediatric cancer.

“Ewing’s sarcoma is the second most common bone malignancy among children and adolescents and there are limited treatment options for patients who relapse or become refractive to therapy,” said John Friend, M.D., chief medical officer of Cellectar. “The ODD for Ewing’s sarcoma represents another important milestone for our CLR 131 pediatric program as we work to bring new options to patients suffering from rare cancers.”

The FDA grants orphan drug designation to therapies targeted at conditions that affect fewer than 200,000 people in the United States. The designation provides seven-year market exclusivity, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the New Drug Application user fee. In 2018 the FDA also granted CLR 131 orphan drug and rare pediatric disease designations for the treatment of neuroblastoma and rhabdomyosarcoma.

Cellectar is currently initiating a Phase 1 clinical study evaluating CLR 131 for the potential treatment of pediatric patients with Ewing’s sarcoma, rhabdomyosarcoma, osteosarcoma, neuroblastoma, high grade glioma and lymphomas. Cellectar has received clearance from the FDA to proceed with an accelerated Phase 1 trial, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CLR 131 in pediatric patients with these cancer types. Further details about the trial can be found at clinicaltrials.gov using the identifier number NCT03478462.

About Ewing’s Sarcoma

Ewing’s sarcoma is the second most common bone malignancy among children and adolescents. According to a study published in the Journal of Hematology/Oncology, the incidence is about 3 cases per 1 million per year in children younger than age 20. Despite the favorable prognosis, an American Cancer Society study showed that approximately 30-40% of patients develop metastases or local recurrence, and the long-term survival rate for refractory or recurrent disease is only 22-24%. The relapsed and refractory statistics underscore the need for new treatment options.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in patients with (R/R) MM exploring fractionated dosing. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.

About Cellectar Biosciences, Inc.

Cellectar Biosciences is focused on the discovery, development and commercialization of drugs for the treatment of cancer. The company plans to develop proprietary drugs independently and through research and development (R&D) collaborations. The core drug development strategy is to leverage our PDC platform to develop therapeutics that specifically target treatment to cancer cells. Through R&D collaborations, the company’s strategy is to generate near-term capital, supplement internal resources, gain access to novel molecules or payloads, accelerate product candidate development and broaden our proprietary and partnered product pipelines.

The company’s lead PDC therapeutic, CLR 131, is in a Phase 1 clinical study in patients with relapsed or refractory (R/R) MM and a Phase 2 clinical study in R/R MM and a range of B-cell malignancies. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer. The company’s product pipeline also includes two preclinical PDC chemotherapeutic programs (CLR 1700 and 1900) and partnered assets include PDCs from multiple R&D collaborations.

For more information please visit www.cellectar.com.

Forward-Looking Statement Disclaimer

This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, the volatile market for priority review vouchers, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2017. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

Source: Cellectar Biosciences, Inc.

Posted: July 2018

Tagged with:

About author

Related Articles