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 the new clinical data of Promitil® in patients with metastatic colorectal cancer will be presented at the American Association for Cancer Research (AACR) annual meeting in Atlanta, Georgia.

This study summarizes data from 72 patients with colorectal cancer within a phase 1A-B study, and follows encouraging preclinical1,2 and clinical results3,4. Promitil achieves disease stabilization and extended survival in a significant fraction of patients with 3rd line chemo-refractory, metastatic colorectal cancer. This study also revealed that the circulating half-life of Promitil may serve as a marker of clinical benefit (stable disease) and prolonged survival.  

The presentation details are as follows:

Session Title: Phase I Clinical Trials: Part 2Session Date and Time:  Monday, April 1, 2019; 8:00 AM - 12:00 PMSession Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17Poster Board Number: 11Permanent Abstract Number: CT054

Dr. Alberto Gabizon, President & CEO of LipoMedix commented: “Treatment of metastatic colorectal cancer after failure with standard chemotherapy is a frequent and unmet need in oncology. The lipidic prodrug of mitomycin-c entrapped in liposomes is an important step towards maximizing survival benefits in this difficult condition.” 

Sanjeev Luther, Chairman of the Board of Lipomedix commented: “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. 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 years1,2.

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 AMERCIAN: 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

References:

1. Gabizon A, Amitay Y, Tzemach D, Gorin J, Shmeeda H, Zalipsky S. Therapeutic efficacy of a lipid-based prodrug of mitomycin C in pegylated liposomes: studies with human gastro-entero-pancreatic ectopic tumor models. J Control Release. 2012 Jun 10;160(2):245-53. doi: 10.1016/j.jconrel.2011.11.019. Epub 2011 Nov 26. 
2. Amitay Y, Shmeeda H, Patil Y, Gorin J, Tzemach D, Mak L, Ohana P, Gabizon A. Pharmacologic Studies of a Prodrug of Mitomycin C in Pegylated Liposomes (Promitil(®)): High Stability in Plasma and Rapid Thiolytic Prodrug Activation in Tissues. Pharm Res. 2016 Mar;33(3):686-700. doi: 10.1007/s11095-015-1819-7. Epub 2015 Nov 16. 
3. Golan T, Grenader T, Ohana P, Amitay Y, Shmeeda H, La‐Beck NM, Tahover E, Berger R, Gabizon AA. Pegylated liposomal mitomycin C prodrug enhances tolerance of mitomycin C: a phase 1 study in advanced solid tumor patients. Cancer Med. 2015 Oct;4(10):1472-83. doi: 10.1002/cam4.491. Epub 2015 Jul 14.  
4. Tahover E, Bar-Shalom R, Sapir E, Pfeffer R, Nemirovsky I, Turner Y, Gips M, Ohana P, Corn BW, Wang AZ, Gabizon AA. Chemo-Radiotherapy of Oligometastases of Colorectal Cancer With Pegylated Liposomal Mitomycin-C Prodrug (Promitil): Mechanistic Basis and Preliminary Clinical Experience. Front Oncol. 2018 Nov 26;8:544. doi: 10.3389/fonc.2018.00544. eCollection 2018.

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ContactSanjeev Luther Chairman of the Board, Lipomedix Pharmaceuticals Ltd.President & CEO, Rafael Pharmaceuticals, Inc.  sanjeev.luther@lipomedix.com

Dr. Alberto Gabizon President & CEO, LipoMedix  alberto.gabizon@lipomedix.com