Lipomedix Announces Initiation of Phase 1b Trial

Lipomedix recently announced the initiation of a Phase 1b multicenter trial (LIPORAD-2018) to identify the optimal dose, safety, and efficacy of its lead compound Promitil in combination with external beam radiotherapy (EBR) in patients with advanced cancer requiring radiotherapy for inoperable primary tumors or metastatic disease.

The primary endpoints of this study will be dose limiting toxicity (DLT), treatment-emergent adverse events and response rate as per RECIST 1.1 criteria. Secondary endpoints of this study will be the evaluation of duration of response, progression-free survival and overall survival.

Lipomedix owns a US patent for Combination therapy comprising a liposomal prodrug of mitomycin C and radiotherapy (US9937261B2). This study is approved by Israel’s Ministry of Health and will be conducted in two medical centers in Israel. The trial is expected to be completed as early as Q1 2020. More information on the trial is available at: www.clinicaltrials.gov(NCT03823989).

The LIPORAD-2018 trial launches following encouraging preclinical and clinical data and data suggesting synergy of Promitil with radiotherapy. A total of 88 patients have been treated with Promitil as a single agent or in combination with other anticancer drugs under the framework of a phase 1 clinical study (Promitil-01). Promitil was well-tolerated and safe for use at the tested doses. The majority of the adverse events reported were mild to moderate and unrelated to the study drug.

Dr. Alberto Gabizon, President & CEO of LipoMedix, said “Besides its promising clinical activity as an agent for treatment of metastatic colon cancer, Promitil is a unique radiosensitizer that has the potential to become a practice-changing and curative tool in chemo-radiotherapy of locally advanced cancers and oligometastatic disease.”

Sanjeev Luther, Chairman of the Board of Lipomedix, added “In addition to our lead trial of Promitil in colorectal cancer, LipoMedix is planning to develop this drug in other difficult-to-treat cancers. Initiation of this trial is one step towards that direction. Lipomedix also has plans to initiate this trial in the US after consultation with the FDA.”

Liposomes are closed lipid vesicles. If liposomes remain long in circulation (eg, 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.

LipoMedix is 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 Lipidic Prodrug (PL-MLP) – overcomes the problems associated with mitomycin-c toxicity and turn 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 and commercialization process of liposomal drugs. Investors in LipoMedix include Rafael Holdings, Inc. (NYSE AMERICAN: RFL). For more information, visit http://www.lipomedix.com.