Big news! check out the bolded paragraph. Our little $18million market cap cancer hopeful has TWO $110-150 million dollar vouchers in their pocket to cash at a future date.
8:00 am ET June 6, 2018 (Globe Newswire) Print
Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131, the company's lead Phospholipid Drug Conjugate(TM) (PDC) product candidate, for the treatment of rhabdomyosarcoma, a rare pediatric cancer.
"There is a critical need for new therapies in the fight against deadly diseases such as rhabdomyosarcoma and we continue to increase our focus on delivering innovative solutions to patients suffering from such rare cancers," said John Friend, M.D., chief medical officer of Cellectar. "The grant of a second RPDD represents an additional regulatory milestone for CLR 131 and we look forward to working with the FDA to advance development of CLR 131 as rapidly as possible, to fully evaluate its potential as a therapeutic option for rhabdomyosarcoma."
Last month, Cellectar announced that the FDA also granted RPDD for CLR 131 for the treatment of neuroblastoma. If CLR 131 is approved by the FDA for either neuroblastoma or rhabdomyosarcoma, the rare pediatric disease designation 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 12 months to six months. Currently, these vouchers can also be transferred or sold to another entity. Over the last 16 months, five priority review vouchers were sold for between $110 million to $150 million each.
The FDA grants RPDD for diseases that primarily affect children from birth to 18 years old, and affect fewer than 200,000 persons in the U.S. This program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
About Rhabdomyosarcoma
Rhabdomyosarcoma (RMS), a malignant tumor of mesenchymal origin, is the most common soft tissue sarcoma in children, accounting for approximately 40% of childhood soft tissue sarcomas in the U.S. The annual incidence is about 4.5 cases per 1 million in children younger than 15 years and more than 50% are younger than 10 years at diagnosis. RMS has a 64% five-year survival in a pediatric population, with at least one-third of all patients experiencing disease progression or relapse [Ward 2014]. The median progression-free survival following the first recurrence or progression is approximately nine months.
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. In 2018 the company plans to initiate a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and a second Phase 1 study in combination with external beam radiation for head and neck cancer.
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