Blog Exposure - Cellectar Receives Rare Pediatric Disease Designation from FDA
Stock Monitor: Seattle Genetics Post Earnings Reporting
LONDON, UK / ACCESSWIRE / May 4, 2018 / If you want access to our free research report on Cellectar Biosciences, Inc. (NASDAQ: CLRB) ("Cellectar") all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=CLRB as the Company's latest news hit the wire. On May 02, 2018, the Company announced that the US Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation (RPDD) to its lead phospholipid drug conjugate, CLR 131, for the treatment of neuroblastoma. Register today and get access to over 1000 Free Research Reports by joining our site below:
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About CLR 131
CLR 131 is Cellectar's investigational radio-iodinated PDC therapy that exploits the tumor-targeting properties of the Company's proprietary phospholipid ether (PLE) and PLE analogs. CLR 131 selectively delivered radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. The therapy is currently in a Phase-2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies, and also in a Phase-1 clinical study in patients with (R/R) MM exploring fractionated dosing.
For Q2 2018, Cellectar is planning to initiate a Phase-1 study with CLR 131 in pediatric solid tumors and lymphoma, as well as a Phase-1 study in combination with external beam radiation for head and neck cancer.
About Neuroblastoma
Neuroblastoma, which is a neoplasm of the sympathetic nervous system, is one of the most common extracranial solid tumor of childhood, accounting for approximately 7.8% of childhood cancers in the United States. Neuroblastoma is also recognized by the FDA as an orphan disease. The incidence is about 10.54 cases per 1 million per year in children younger than 15 years, and 90% of children are younger than 5 years at diagnosis. Approximately 50% of patients present with metastatic disease require systemic treatment. Although the prognosis is favorable in children under one year of age with an 86% to 95% 5-year survival, in children aged 1 to 14 years, the 5-year survival ranges from 34% to 68%.
Benefits of the Rare Pediatric Disease Designation (RPDD) to Cellectar
The FDA grants the RPDD for diseases that primarily affect children from birth to 18 years of age, and affect fewer than 200,000 persons in the US. This program is intended to encourage the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
If CLR 131 is approved by the FDA for neuroblastoma, the RPDD may enable Cellectar to receive a priority review voucher. Priority review vouchers can be used by the sponsor to receive Priority Review for a future NDA or BLA submission, which would reduce the FDA review time from twelve months to six months. Currently, these vouchers can also be transferred or sold to another entity. Over the last 16 months, 5 priority review vouchers were sold for between $110 million to $150 million each.
About Cellectar Biosciences, Inc.
Cellectar 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 its PDC platform to develop therapeutics that specifically target treatment to cancer cells. Through R&D collaborations, Cellectar's strategy is to generate near-term capital, supplement internal resources, gain access to novel molecules or payloads, accelerate product candidate development, and broaden its proprietary and partnered product pipelines.
Stock Performance Snapshot
May 3, 2018 - At Thursday's closing bell, Cellectar Biosciences' stock fell 1.74%, ending the trading session at $1.13.
Volume traded for the day: 102.22 thousand shares.
Stock performance in the last month – up 0.64%
After yesterday's close, Cellectar Biosciences' market cap was at $18.96 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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