NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) has unveiled key clinical efficacy data for rigosertib, showcasing its potential as a treatment for squamous cell carcinoma (SCC) associated with recessive dystrophic epidermolysis bullosa (RDEB). The findings, published in the British Journal of Dermatology, mark a significant step forward in addressing a devastating disease with no approved therapies.
The data stems from the first clinical trial of an experimental cancer treatment specifically targeting RDEB-associated SCC. Results demonstrated an impressive overall response rate of 80%, with complete responses in 50% of evaluable patients.
“These data indicate that rigosertib is a potential treatment for cutaneous SCC in RDEB patients, where there is a substantial unmet need and no approved therapies,” said Victor Moyo, MD, Chief Medical Officer Oncology at Traws Pharma. “The aggressive course of this disease is inadequately addressed by current treatment regimens, which produce limited response rates of mostly short duration.”
A Critical Unmet Need
RDEB is a monogenic condition characterized by insufficient expression of type VII collagen, which compromises the structural integrity of the skin. This results in chronic blistering, wound formation, and frequent infections. Many patients with RDEB eventually develop metastatic SCC, an aggressive and deadly complication driven by overexpression of polo-like kinase 1 (PLK-1). The disease often manifests in children or young adults, with a grim prognosis that sees up to 70% and 78.7% of patients succumbing by ages 45 and 55, respectively.
Current treatment options, including targeted therapies and conventional chemotherapy or radiotherapy, have shown limited efficacy and durability, underscoring the urgent need for new therapeutic approaches.
A Path Forward
Rigosertib, a legacy Traws Pharma oncology asset, is now being positioned for further development and commercialization as part of the company’s broader commitment to advancing solutions for rare and challenging diseases.
“We are excited to report the compelling efficacy and tolerability profile of rigosertib in this devastating, difficult-to-treat disease, and thank the patients, sponsors, and investigators for their commitment to this program,” said Iain Dukes, MA, DPhil, Interim CEO of Traws Pharma. “Rigosertib is available for further development and commercialization, and we are committed to finding an appropriate partner to advance this important medicine to approval.”
Broader Implications
The publication of this data not only highlights the potential of rigosertib but also shines a light on the critical need for innovation in the treatment of rare cancers. By targeting the specific mechanisms driving RDEB-associated SCC, Traws Pharma is offering hope to a patient population that has long faced limited options and dire outcomes.
With the search for a development and commercialization partner underway, Traws Pharma aims to accelerate rigosertib’s path to regulatory approval and eventual availability for patients in desperate need. This milestone underscores the importance of collaboration and research in paving the way for groundbreaking advancements in oncology.
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