RFL Rafael Holdings Inc

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.”  

About Promitil®Liposomes are closed lipid vesicles. If liposomes remain long in circulation (e.g. pegylated liposomes), they tend to accumulate in tumors due to the enhanced permeability and retention (EPR) effect. LipoMedix has developed a pegylated liposome delivery platform based on the encapsulation of a new chemical entity (NCE) known as mitomycin-c lipidic prodrug (MLP), a proprietary prodrug form of the anticancer agent mitomycin-c. Promitil® enables efficient and selective tumor delivery of MLP with rapid activation to a powerful mitomycin-c metabolite. Promitil® has low toxicity and is active against a broad variety of cancer types in animal models including colorectal, gastric, pancreatic, and multi-drug resistant tumors. Promitil® is a highly stable formulation with prolonged storage shelf life of over 5 years.

About LipoMedixLipoMedix, a clinical-stage, oncology focused pharmaceutical company, involved in the development of an innovative, safe and effective cancer therapy based on a pegylated liposomal drug delivery platform. The Company was established in order to advance the pharmaceutical and clinical development of a patented new chemical entity prodrug of mitomycin-c and its efficient delivery in liposomes to cancer-affected target organs. This formulation known as Promitil® – Pegylated Liposomal Mitomycin-c Prodrug (PL-MLP) – overcomes the problems associated with mitomycin-c toxicity and turns it into a state-of-the-art anti-cancer drug that will potentially become the therapy of choice in a variety of cancers, especially those derived from the gastrointestinal tract (stomach, pancreas, colorectal). The inventor and scientific founder of LipoMedix is Prof. Alberto Gabizon of the Hebrew University– Shaare Zedek Medical Center, who is also the co-inventor and co-developer of Doxil®, (the first FDA-approved nano-drug in cancer therapy). As co-developer of Doxil®, Prof. Gabizon is one of the few scientists intimately familiar with the successful development & commercialization process of liposomal drugs. For more information, visit http://www.lipomedix.com/

About Rafael Holdings, Inc. Rafael Holdings (NYSE AMERICAN: RFL) holds commercial real estate assets and interests in two clinical stage pharmaceutical companies. The real estate holdings consist of properties in Newark and Piscataway, New Jersey and in Jerusalem, Israel. The pharmaceutical holdings comprise majority interests in Rafael Pharmaceuticals, Inc., and in Lipomedix Pharmaceuticals Ltd. Both are focused on the development and commercialization of drugs in the oncology space. For more information, visit  www.rafaelholdings.com

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Media Contact:Holly Duganrafael@antennagroup.com (201) 465-8019