{"id":"isis-3521","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ISIS 3521 works by binding to and degrading the mRNA encoding protein kinase C-alpha, a signaling enzyme overexpressed in many cancers that promotes cell survival and proliferation. By reducing PKC-alpha levels, the drug aims to induce apoptosis in cancer cells and enhance sensitivity to chemotherapy and radiation. This antisense approach targets a key survival pathway in malignant cells.","oneSentence":"ISIS 3521 is an antisense oligonucleotide that inhibits protein kinase C-alpha (PKC-alpha) expression to suppress cancer cell proliferation and survival.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:17:18.164Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Ovarian cancer"},{"name":"Colorectal cancer"}]},"trialDetails":[{"nctId":"NCT00003236","phase":"PHASE2","title":"Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer","status":"COMPLETED","sponsor":"Eastern Cooperative Oncology Group","startDate":"1998-07-13","conditions":"Breast Cancer","enrollment":""},{"nctId":"NCT00017407","phase":"PHASE3","title":"Carboplatin and Paclitaxel With or Without ISIS 3521 in Treating Patients With Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"Ionis Pharmaceuticals, Inc.","startDate":"2000-10-13","conditions":"Lung Cancer","enrollment":""},{"nctId":"NCT00003989","phase":"PHASE2","title":"ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma","status":"COMPLETED","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","startDate":"1998-06","conditions":"Lung Cancer, Melanoma (Skin)","enrollment":50},{"nctId":"NCT00034268","phase":"PHASE3","title":"A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2002-03","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":""},{"nctId":"NCT00042679","phase":"PHASE2","title":"A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer.","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2002-06","conditions":"Carcinoma, Non-Small-Cell Lung, Pulmonary Neoplasms, Neoplasms, Lung","enrollment":""}],"_emaApprovals":[],"_faersSignals":[{"count":3,"reaction":"DYSPNOEA"},{"count":3,"reaction":"HAEMOGLOBIN DECREASED"},{"count":2,"reaction":"ABDOMINAL PAIN"},{"count":2,"reaction":"LOBAR PNEUMONIA"},{"count":2,"reaction":"PLATELET COUNT DECREASED"},{"count":2,"reaction":"PNEUMONIA"},{"count":2,"reaction":"SHOCK"},{"count":2,"reaction":"TROPONIN T INCREASED"},{"count":1,"reaction":"ACUTE CORONARY SYNDROME"},{"count":1,"reaction":"ANGINA UNSTABLE"}],"_approvalHistory":[],"publicationCount":33,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"ISIS 3521","genericName":"ISIS 3521","companyName":"European Organisation for Research and Treatment of Cancer - EORTC","companyId":"european-organisation-for-research-and-treatment-of-cancer-eortc","modality":"Biologic","firstApprovalDate":"","aiSummary":"ISIS 3521 is an antisense oligonucleotide that inhibits protein kinase C-alpha (PKC-alpha) expression to suppress cancer cell proliferation and survival. Used for Non-small cell lung cancer, Ovarian cancer, Colorectal cancer.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}