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news.Introgen Therapeutics has presented positive results from a study evaluating its cancer-suppressing gene in lung cancer patients.
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The company said the cancer-suppressing gene, FUS1, has been successfully delivered into the tumors of lung cancer patients via its lipid nanoparticle product candidate.
In a phase I trial FUS1 was found to be active in patients’ metastatic non-small cell lung cancer tumors. This is the first clinical demonstration that a gene can be injected intravenously and be taken up and expressed at high levels in cancer cells at distant sites.
Thirteen patients were treated in this first-in-human study with no significant drug-related toxicity. Median survival time for all patients is 14.6 months which compares favorably to a seven-month median survival time for patients receiving second line therapy. The clinical trial continues and no maximum tolerated dose has been established.
Introgen is working on the design of a pivotal study for the lipid nanoparticle product candidate INGN 401, and the incorporation of FUS1 biomarkers in INGN 401 development programs.