LipoMedix Announces Publication of Positive Phase 1 Data for Promitil (PL-MLP) in Research Journal Investigational New Drugs

Study authors found that Promitil may be a useful agent in patients with metastatic colorectal cancer (CRC)

JERUSALEM, Jan. 23, 2020 (GLOBE NEWSWIRE) -- LipoMedix, a clinical-stage, oncology-focused pharmaceutical company, involved in the development of innovative, safe and effective cancer therapy based on a pegylated liposomal drug delivery platform, today announced that Phase 1 data of Promitil (PL-MLP) in patients with metastatic colorectal cancer (CRC) was published in the research journal Investigational New Drugs. The study demonstrated positive results on the pharmacokinetics and clinical observations of the drug.

This study analyzed 53 patients with advanced, treatment-refractory CRC treated with Promitil either as a single agent or in combination with capecitabine and/or bevacizumab. Promitil was well-tolerated with a good safety profile, as previously reported. Promitil treatment resulted in a substantial rate of disease stabilization, reported in 15 out of 36 efficacy-evaluable patients (42%). Prolonged survival of stable disease patients was also observed, with a median survival of 14.4 months, significantly longer than of progressive disease patients (6.5 months) and non-evaluable patients (2.3 months).

A long circulating half-life of Promitil was associated with stable disease and longer survival. This finding is consistent with the enhanced tumor localization of long circulating liposomes that could result in improved disease and underscores the relevance of personalized pharmacokinetic evaluation in the use of nanomedicines. 

“Treatment of metastatic colorectal cancer after failure to standard chemotherapy is a frequent and unmet need in oncology,” said Dr. Alberto Gabizon, President and Chief Scientific Officer of LipoMedix. “The lipidic prodrug of mitomycin-c entrapped in liposomes is an important step towards maximizing survival benefits in this difficult condition. Further, the results of the current study suggest ways that could predict treatment outcome soon after treatment is initiated and help select patients that will benefit from Promitil.”

“The treatment of metastatic colorectal cancer has undergone major advances yielding significant improvements in survival over the past two decades, yet remains disappointing in pre-treated patients with advanced stage cancer,” said Sanjeev Luther, Chairman of the Board of LipoMedix. “The development of Promitil represents a novel and smart tool to overcome the problems associated with mitomycin-c toxicity with an optimized liposomal delivery system reducing normal tissue exposure and enhancing cancer tissue uptake.”