LipoMedix Announces Publication of Positive Phase 1 Data for Promitil® (PL-MLP) in Research Journal Investigational New Drug...
January 23 2020 - 8:00AM
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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statements are only predictions. Actual events or results may
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result of various important factors. Although we believe that the
expectations reflected in the forward-looking statements are
reasonable, such statements should not be regarded as a
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forward-looking statements will be achieved. The business and
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In light of the foregoing, readers are cautioned not to place undue
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Media Contact:Holly
Duganrafael@antennagroup.com (201) 465-8019
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