CeNeRx BioPharma now has clearance to move forward on human trials of a drug candidate aimed at improving the nerve damage cancer patients can experience from cancer treatments.
The drug development company said the U.S. Food and Drug Administration has approved its investigational new drug application for a compound called CXB909. The compound enhances the effects of nerve growth factor and is believed to support acetylcholine, a neurotransmitter that plays a role in musculoskeletal movement.
CeNeRx, based in Cary, North Carolina, said that nerve growth factor is important for the function and survival of several types of neurons and it may help prevent or even reverse neuron damage that causes peripheral neuropathy, a condition characterized by numbness, tingling or burning sensations typically starting in the hands and feet. The condition can be caused by cancer treatments.
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Alzheimer’s disease and Huntington’s disease could also be targets for the company. CeNeRx said the degeneration of neurons associated with those diseases may be helped by increased levels of nerve growth factor. But the company is targeting chemotherapy-induced peripheral neuorpathy as its first potential indication.
An initial phase I study showed that single doses of CXB909 were well tolerated. The company said it is now preparing to launch additional phase I studies studying peripheral neuropathy.
CeNeRx is also developing treatments for depression. The company’s drug candidate TriRima is currently in phase II clinical trials. The company last August completed a $13 million series C round of financing. CeNeRx’s venture capital backers include Perseus Soros BioPharmaceutical Fund, L Capital Partners and Pappas Ventures.