title: MitoExtra SuperGen.
abstract: SuperGen Inc is developing a cyclodextrin-based reformulation of mitomycin C (MitoExtra) for the potential treatment of gastic, pancreatic, breast lung and colorectal cancers. In April 2002, the NDA was pending approval from the US FDA after a March 2002 filing of a final response including data from a phase II trial [447618]. MitoExtra is a proprietary reformulation of the approved anticancer drug mitomycin C. SuperGen's reformulation is based on technology designed to improve the handling characteristics and safety profile of mitomycin C and other anticancer drugs by enhancing the drug's stability in solution form and 'shielding' it at the injection site [205482]. In a phase II study in patients with advanced solid tumors, MitoExtra showed no evidence of diminished efficacy or unexpected toxicity [447618]. In April 2000, SuperGen' was issued US-06048845, protecting the company's proprietary Extra technology platform [363494].
authors.affiliation: Novartis Pharma AG, Basel, Switzerland. konstantina.grosios@pharma.novartis.com
authors.forename: Konstantina
authors.initials: K
authors.lastname: Grosios
mesh_terms: D000073738:2-Hydroxypropyl-beta-cyclodextrin; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000378:metabolism / Q000494:pharmacology*; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D003505:Cyclodextrins; D005079:Excipients; D006801:Humans; D007275:Injections, Intravenous; D016685:Mitomycin / Q000009:adverse effects / Q000378:metabolism / Q000494:pharmacology*; D013329:Structure-Activity Relationship; D047392:beta-Cyclodextrins
chemical_list: D000970:Antineoplastic Agents; D003505:Cyclodextrins; D005079:Excipients; D047392:beta-Cyclodextrins; D000073738:2-Hydroxypropyl-beta-cyclodextrin; D016685:Mitomycin