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Dogwood Therapeutics Announces FDA Acceptance of SP16 Investigational New Drug Application for the Treatment of Chemotherapy Induced Pain and Neuropathy
Dogwood licensed SP16 to treat cancer-related pain from partner and regulatory sponsor Serpin Pharma The SP16 Phase 1b trial fully funded by the National
About this update from Dogwood Therapeutics, Inc.
[{"type":"text","content":"Dogwood licensed SP16 to treat cancer-related pain from partner and regulatory sponsor Serpin Pharma The SP16 Phase 1b trial fully funded by the National Cancer Institute; Patient enrollment expected to commence in the middle of 2026 at the University of Virginia ALPHARETTA, Ga., April 15, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (NASDAQ: DWTX) (“DWTX”, “Dogwood” or “the Company”), a company that focuses on developing new non-opioid medicines to treat pain and neuropathy, today announced FDA acceptance of an Investigational New Drug (“IND”) application for its development candidate SP16, administered intravenously (“IV”), for the treatment of chemotherapy-induced pain and peripheral neuropathy (“CIPPN”). SP16 is administered via IV infusion with two hypothesized actions: anti-inflammatory actions via reduction of IL-6, IL-8, IL-1β and TNF-alpha, and tissue repair via increases in pAKT and pERK that regulate and promote fundamental processes like growth, proliferation, and survival. The Company and its partner Serpin Pharma anticipate patient enrollment in the SP16 Phase 1b trial to begin in the middle of 2026. Serpin Pharma has been awarded a $2.5 million grant from the National Cancer Institute (“NCI”), which will fully fund the forthcoming SP16 Phase 1b CIPPN clinical trial. “FDA acceptance of our SP16 IND filing represents an important step in expanding our pipeline as we advance a second development candidate into the clinic to treat chemotherapy-induced neuropathy and pain,” said Greg Duncan, Chairman and Chief Executive Officer of Dogwood Therapeutics. “SP16 compliments our lead candidate, Halneuron®, by not only targeting neuropathic pain but also addressing additional debilitating symptoms of neurotoxic chemotherapy, including numbness, tingling and impaired motor function.” Incidence of CIPPN is high, affecting approximately 30-40% of patients six months after receiving neurotoxic chemotherapy, and can persist long-term in many patients. Key risk factors for the development of these symptoms include use of platinum or taxane containing drugs, higher chemotherapeutic doses, and underlying diabetes. Common symptoms associated with CIPPN are numbness, tingling, and pain, symptoms that directly impact quality of life in these cancer survivors. In September 2025, Dogwood secured the SP16 royalty-free, global licen...