Product (Promitil® Overview)

LipoMedix Pharmaceutical Inc. has developed Promitil®, a proprietary formulation of a lipid-based pro-drug of MMC (MLP) which enables efficient delivery and release of active MMC to tumors in vivo. Promitil® is a liposomal formulation designed to reduce the systemic toxicity associated with free mitomycin C (MMC). It is engineered for prolonged circulation in the bloodstream and stable retention of the pro-drug, with the potential for controlled release under specific conditions. Preclinical and early clinical data suggest that Promitil® may help improve the therapeutic index of MMC, including in settings of drug resistance, though further studies are ongoing.
 
 
Pharmacokinetics of Promitil and free MMC in mice
 
The technology is derived from a unique lipid-based Prodrug of Mitomycin-C (MMC: 2,3- (distearoyloxy)propane-1-dithio-4Vbenzyloxycarbonyl) specially designed for liposome formulation.
 
 
 
The lipid anchor in the Mitomycin C lipidic prodrug (MLP) was designed to ensure a strong and stable association with liposomal membranes, supporting prolonged circulation. The thio-benzyl bridge connecting the lipophilic anchor to the mitomycin C (MMC) moiety is cleavable by reducing agents, which are often present at elevated levels in the tumor microenvironment. This cleavage enables site-specific release of active MMC following accumulation in target tissues. Promitil® is being developed as a liposomal anticancer agent with the goal of reducing systemic toxicity relative to free MMC. In preclinical tumor models, Promitil® demonstrated therapeutic activity in settings where free MMC was limited by toxicity, including models of multi-drug-resistant tumors. These studies showed extended survival in animals treated with Promitil®, suggesting potential for enhanced therapeutic efficacy. Promitil® is currently in clinical development, where its safety and efficacy in humans are being evaluated. While preclinical data are encouraging, clinical trials are needed to determine whether similar outcomes will be observed in patients.
 
Superior Efficacy of Promitil over Dox

 

Therapeutic Effect of PL-MLP in mouse MDR tumor model (M109R). DOXIL™, 10 mg/kg q7dx2; PL-MLP, 35 mg/kg (10 mg/kg MMC=equivalents) q7dx2
 
 
The Pegylated Liposomal Formulation of Mitomycin-C Lipid-based Prodrug (Promitil®) is an investigational drug delivery system designed to optimize the therapeutic potential of mitomycin C while minimizing systemic toxicity. Its development incorporates several features intended to improve drug delivery and tumor targeting:
  • Utilizes a prodrug form of mitomycin C—an established chemotherapeutic agent—with the goal of reducing toxicity and enhancing tumor-specific activation
  • Designed for selective activation within the tumor microenvironment
  • Exhibits extended circulation time and potential for improved pharmacokinetics
  • Demonstrates antitumor activity in preclinical models across several cancer types
  • Shows activity in preclinical models of multidrug-resistant tumors
  • Based on a well-established pegylated liposomal platform
  • Being evaluated for potential use in combination with other anticancer therapies
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