First Patient Dosed in Trial for Chemotherapy-Induced Neuropathic Pain

First patient dosed in phase 2b trial of Halneuron for chemotherapy-induced neuropathic pain, a first-in-class agent targeting the NaV 1.7 sodium channel.

The first patient has been dosed in the phase 2b HALT-CINP (Halneuron® Treatment of Chemotherapy-Induced Neuropathic Pain) clinical trial evaluating the first-in-class agent Halneuron for those with neuropathic pain associated with prior chemotherapy treatment, according to a press release from Dogwood Therapeutics, Inc.

The agent is being developed as an alternative to chronic pain treatment with opioids, as stated in the news release, and patients treated with the agent demonstrated a statistically significant reduction in cancer-related pain in a previous phase 2 clinical trial. Importantly, the agent has an acceptable safety profile.

“Halneuron is being developed to specifically inhibit the NaV 1.7 sodium channel, given the well-established role of this target in pain transmission,” said Dogwood’s chairman and chief executive officer, Greg Duncan. “We believe Halneuron’s inherent specificity and potency may enable physicians to use very low doses of Halneuron to both reduce pain and minimize the off-target effects that have limited prior NaV 1.7 development candidates.”

Halneuron is a first-in-class agent which acts as a NaV 1.7 specific voltage gated sodium channel inhibitor. This means that the agent selectively blocks the NaV1.7 sodium channel, a key player in pain signaling, without affecting other sodium channel isoforms, according to PubMed Central. Additionally, Halneuron has been evaluated in multiple phase 1 and phase 2 studies in over 700 patients.

“Our goal is to recruit 100 patients with [chemotherapy-induced neuropathic pain] by the fourth quarter of 2025, which should allow us to execute an interim analysis on the HALT-CINP trial in the fourth quarter of 2025,” Dr. R. Michael Gendreau, Dogwood’s chief medical officer emphasized in the news release. “This proposed interim analysis will inform our adaptive trial design, enabling changes to the study, if necessary, to improve trial outcomes.”

What is Chemotherapy-Induced Neuropathy?

According to the American Cancer Society, peripheral neuropathy is a condition caused by damage to the peripheral nervous system which can cause pain, tingling, numbness or sensitivity, which often presents in the hands or feet. Specifically, chemotherapy-induced peripheral neuropathy is a result of medicines used to treat cancer and can affect motor nerves, sensory nerves and autonomic nerves. An article from JAMA Oncology describes chemotherapy-induced peripheral neuropathy as feeling like tingling (“pins and needles”); pain, which may be severe, constant, it may come and go, or may feel like burning; decreased sensation (“legs feel like jelly”); increased sensitivity to touch, temperature, pressure or pain; and muscle weakness.

Importantly, the American Cancer Society goes on to explain that chemotherapy-induced peripheral neuropathy can cause severe pain, in turn, affecting the way individuals move and walk, as well as write. The side effects can last for weeks, months and years after treatment is completed.

Chemotherapy drugs like platinum drugs, including oxaliplatin; taxanes, like docetaxel; vinca alkaloids, such as vincristine; and myeloma treatments, including Velcade (bortezomib), can all cause chemotherapy-induced peripheral neuropathy, according to JAMA Oncology; however, it is possible for other cancer treatments to cause it as well. Notably, patients who receive higher doses of treatment, multiple courses of treatment or combination therapies, as well as those who are older, have diabetes, vitamin deficiencies or preexisting peripheral neuropathy are more likely to develop chemotherapy-induced peripheral neuropathy, according to the source.

The treatment of chemotherapy-induced peripheral neuropathy can consist of dose changes, including lowering the dose of the anti-cancer drug, or discontinuation of therapy altogether, according to Johns Hopkins Medicine. JAMA Oncology also notes that over-the-counter pain medications, lidocaine patches or menthol creams may be recomended, as is physical therapy, occupational therapy and rehabilitation.

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