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 its lead compound,
Promitil® (PL-MLP), will be manufactured in the United States by
ForDoz Pharma (ForDoz), a privately owned, specialty pharmaceutical
company focused on the development, manufacturing, and
commercialization of value-added sterile and complex injectable
products.
Promitil’s unique formulation is designed for
selective delivery of the therapeutic agent to cancer-affected
tissues and is ideally suited for cancer chemoradiotherapy. The
compound consists of the liposome-based encapsulation of a new
chemical entity called Mitomycin-c (MMC) lipidic prodrug (MLP),
which is a proprietary prodrug form of the known anticancer agent
MMC. In studies, it has been shown to be active against a broad
variety of cancer types in animal models, including colorectal,
gastric, pancreatic and multi-drug-resistant tumors.
“We continue to move full-steam ahead, knowing that
the patients we can help with Promitil have been long awaiting a
lower-toxicity and effective treatment option,” said Dr. Alberto
Gabizon, President and Chief Scientific Officer of LipoMedix. “We
are thinking long term when selecting our partnerships and look
forward to partnering with ForDoz as we move toward Phase II
studies to move the development of Promitil forward.”
By leveraging ForDoz’s drug delivery technology and
experience, LipoMedix expects to be able to effectively
troubleshoot the many industry-wide challenges of product
development and manufacturing of nanotechnology.
“ForDoz has a proven track record in manufacturing
and in successful commercialization,” said Sanjeev Luther,
Executive Chairman of the Board of LipoMedix. “Selecting the right
partner for each step of the journey is critical to the strategic
process of developing a drug and we believe ForDoz is that
partner.”
“Our mission is to ultimately aid in the delivery
of innovative medicines that will help people live longer, better
and easier lives,” said James He, founder and CEO of ForDoz. “It
was immediately apparent that the team at LipoMedix has patients
top of mind, and we are proud to partner with them to manufacture
Promitil here in the U.S.''
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 the efficient and selective tumor
delivery of MLP with rapid activation to a powerful mitomycin-c
metabolite. Promitil® has shown low toxicity and is anticipated to
be 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 five years. In phase 1A and 1B clinical
studies conducted in over 100 cancer patients, Promitil® has shown
a favorable safety profile and reduced toxicity as compared to
equivalent doses of mitomycin-c. Encouraging signs of antitumor
activity have been observed particularly in combination with
radiotherapy.
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®, or Pegylated Liposomal Mitomycin-c Prodrug (PL-MLP), is
believed to overcome the challenges associated with mitomycin-c
toxicity and turns it into a state-of-the-art anti-cancer drug that
can potentially become the therapy of choice in a variety of
cancers, especially those of the gastrointestinal tract (stomach,
pancreas, colorectal). The inventor and scientific founder of
LipoMedix is Prof. Alberto Gabizon of 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
who is intimately familiar with the successful development and
commercialization process for liposomal drugs. For more
information, visit http://www.lipomedix.com/.
About Rafael Holdings, Inc. Rafael Holdings
is focused on the development of novel cancer therapies. The
company is a significant investor in two clinical-stage oncology
companies, Rafael Pharmaceuticals, Inc. and LipoMedix
Pharmaceuticals Ltd. Through its wholly-owned Barer Institute
subsidiary, the company is developing compounds focused on the
regulation of cancer metabolism. The company also holds
commercial real estate assets in New
Jersey and Jerusalem. For more information,
visit rafaelholdings.com.
About ForDozForDoz Pharma Corp. is a
privately owned, specialty pharmaceutical company focusing on the
development, manufacturing and commercialization of value-added
sterile and complex injectable products such as liposomes,
microspheres, micelles, nanosuspensions and
microcrystal-suspensions. ForDoz Pharma is located on a 27-acre
campus in the greater Princeton area of New Jersey, a prominent
pharmaceutical hub in the United States. The campus is the site of
ForDoz Pharma’s R&D labs, cGMP QC and microbiology labs and a
fully qualified and validated sterile complex injectable product
manufacturing facility which complies with both U.S. and EU cGMP
standards. ForDoz Pharma is accelerating and improving traditional
drug development processes through its proprietary, particle-based,
drug delivery technology platform with particle sizes ranging from
10 nm to several µm. At ForDoz Pharma, we can commercialize
products as a CDMO partner via a closed-loop system, from R&D,
analytical testing and process scale-up to commercial
manufacturing, all from our one campus.
Please visit www.fordozpharma.com for more
information.LinkedIn:
www.linkedin.com/company/fordoz-pharma-corp/.
Safe Harbor StatementThis press release
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In light of the foregoing, readers are cautioned not to place undue
reliance on such forward-looking statements.
Rafael Media Contact:Diana
Cleinmarkrafael@antennagroup.com (408) 713-1216
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