Lipomedix Announces Initiation of Phase 1b Trial (LIPORAD-2018) of Promitil® in Combination with Radiotherapy in Patients wi...
March 04 2019 - 11:15AM
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 LipoMedixLipoMedix 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:
- 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.
- 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.
- 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.
- 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.
- 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.
Safe Harbor Statement
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inherent in forward-looking statements. We undertake no duty to
update any of the forward-looking statements, whether as a result
of new information, future events or otherwise. In light of the
foregoing, readers are cautioned not to place undue reliance on
such forward-looking statements.
ContactSanjeev LutherChairman
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
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