FDA Transfers Sponsorship Of RTX Orphan Status From NIH To Sorrento
Sorrento Therapeutics announced that the U.S. Office of Orphan Products Development at the Food and Drug Administration (FDA) has approved the transfer of the Orphan Drug Designation sponsorship for its pain drug intrathecal resiniferatoxin (RTX).
The approval will transfer the sponsorship of the drug from the National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research to Sorrento Therapeutics. Henry Ji, president and CEO of Sorrento, said that it will enable the company to move the drug towards registration. “Sorrento is currently working with the NIH under a cooperative research agreement to conduct an ongoing Phase 1/2 trial of RTX for the treatment of intractable pain in advanced cancer. We intend to file the Investigational New Drug (IND) application and commence a pivotal Phase 2 study in 2015 with this promising product candidate.”
Resiniferatoxin is a non-opioid based pain treatment with a different mechanism of action compared to other painkillers. The drug is a TRPV1 agonist highly selective of the TRPV1 receptor. Stimulation of TRPV1 results in the overexpression of the receptor through selective ablation of fiber neurons. A single intraspinal injection of the drug is expected to block transmission of pain signals without impacting normal sensation, motor control, or causing sedation and cognitive impairment.
John Heiss, branch chair and neurosurgery residency program director Surgical Neurology Branch at the National Institutes of Neurological Diseases and Stroke, said, “Resiniferatoxin has the potential to be a significant treatment option for the severe unmet need associated with the treatment of intractable pain in cancer patients.”
Initial data from the current NIH trial demonstrated clinically significant pain reduction in patients. Preliminary data from the trial were presented at the 39th Annual Regional Anesthesia and Acute Pain Meeting of the American Society of Regional Anesthesia and Pain Medicine and the 33rd Annual Scientific Meeting of the American Pain Society.