Lipomedix Announces Initiation Of Phase 1b Trial (LIPORAD-2018) Of Promitil® In Combination With Radiotherapy In Patients With Advanced Cancer

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.

Givat Ram High-Tech Village, Jerusalem (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 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 U.S. 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 preclinical¹,² and clinical data³ and data suggesting synergy of Promitil® with radiotherapy⁴,⁵. 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 drug3.

Dr. Alberto Gabizon, President & CEO of LipoMedix commented: “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 commented: “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 U.S. after consultation with the FDA.”

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 LipoMedix
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 & commercialization process of liposomal drugs. Investors in LipoMedix include Rafael Holdings, Inc. (NYSE AMERICAN: RFL). For more information, visit http://www.lipomedix.com

About Rafael Holdings, Inc.
Rafael Holdings 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 Jerusalem, Israel. The pharmaceutical holdings comprise majority interests in Rafael Pharmaceuticals, Inc., and Lipomedix Pharmaceuticals Ltd. Both are focused on 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. Tian X, Warner SB, Wagner KT, Caster JM, Zhang T, Ohana P, Gabizon AA, Wang AZ. Preclinical Evaluation of Promitil, a Radiation-Responsive Liposomal Formulation of Mitomycin C Prodrug, in Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2016 Nov 1;96(3):547-55. doi: 10.1016/j.ijrobp.2016.06.2457. Epub 2016 Jul 1.

^5. 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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