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MitoExtra SuperGen
1Novartis Pharma AG, Basel, Switzerland. konstantina.grosios@pharma.novartis.com
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].
Insights
SuperGen Inc. is developing MitoExtra, a new formulation of mitomycin C, for various cancers. Phase II trials show it is safe and effective for advanced solid tumors.
Area of Science:
- Oncology
- Pharmaceutical Sciences
- Drug Development
Background:
- Mitomycin C is an approved anticancer drug.
- Existing formulations present handling and safety challenges.
- SuperGen Inc. developed a proprietary cyclodextrin-based technology platform called Extra.
Purpose of the Study:
- To evaluate the safety and efficacy of MitoExtra, a novel reformulation of mitomycin C.
- To assess the potential of MitoExtra for treating gastric, pancreatic, breast, lung, and colorectal cancers.
Main Methods:
- A Phase II clinical trial was conducted in patients with advanced solid tumors.
- MitoExtra utilizes cyclodextrin-based technology to improve stability and safety at the injection site.
- Data from the Phase II trial were included in a final response to the US FDA.
Main Results:
- MitoExtra demonstrated no evidence of diminished efficacy compared to mitomycin C.
- No unexpected toxicity was observed in the Phase II study.
- The reformulation enhances drug stability and improves handling characteristics.
Conclusions:
- MitoExtra represents a promising advancement in mitomycin C drug delivery.
- The cyclodextrin-based technology offers improved safety and handling for anticancer drugs.
- MitoExtra is being considered for regulatory approval for multiple cancer types.