LipoMedix Announces Manufacturing Agreement with ForDoz for Promitil®
JERUSALEM, Israel, Feb. 10, 2021 (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 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.''
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.
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®, 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.
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.
ForDoz 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.
Safe Harbor Statement
This press release contains forward-looking statements. These statements relate to future events or the company’s future financial performance. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "expect", "plan", "anticipate", "believe", "estimate", "predict", "potential" or "continue", the negative of such terms, or other comparable terminology. These statements are only predictions. Actual events or results may differ materially from those in the forward-looking statements as a 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 representation by the company, or any other person, that such forward-looking statements will be achieved. The business and operations of the company are subject to substantial risks which increase the uncertainty 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.
November 2020: Lipomedix Pharmaceuticals has been awarded the Seal of Excellence for the project " A unique ‘smart’ nanomedicine for a safer and more effective chemo-radiotherapy" submitted under the Horizon 2020’s SME Instrument call H2020-EIC-SMEInst-2018-2020 (H2020-EIC-SMEInst-2018-2020-3) in the area of EIC-SMEInst-2018-2020
November 2020: The European Patent Office has issued a notice of allowance for Lipomedix patent application entitled "Methods for the Treatment of Bladder Cancer" (#3270898)
August 2020: The European Patent Office has granted Lipomedix patent (# 3151863) entitled "Combination Therapy Comprising A Liposomal Prodrug of Mitomycin C and Radiotherapy"
April 2020: The USPTO has granted Lipomedix patent (#10617672) entitled " Liposome Composition Co-Encapsulating Doxorubicin and A Prodrug of Mitomycin C"
LipoMedix Appoints New Members to Board of Directors and Creates New Executive Committee
Jerusalem, Aug. 05, 2019 (GLOBE NEWSWIRE)
LipoMedix Pharmaceuticals Ltd., a clinical and development-stage company focused on the development of an innovative, safe and effective cancer therapy based on liposome delivery, today announced the addition of Miranda J. Toledano and Praveen Tyle, Ph.D., to its board of directors. The company also announced the formation of an executive committee of the board to enhance governance and support the company’s development. Ms. Toledano and Dr. Tyle will join Sanjeev Luther, chairman of the board, on the newly formed executive committee.
“We continue to build LipoMedix’ pharmaceutical franchise with additional talented directors,” said Howard Jonas, chairman of Rafael Holdings, controlling shareholder of LipoMedix. “I am pleased to welcome Miranda and Praveen to the board and look forward to their contributions to help advance the company and its lead product, Promitil®.”
Ms. Toledano has over 20 years of executive experience in the biopharmaceutical sector. She is currently the chief operating officer and chief financial officer of TRIGR Therapeutics, a clinical stage immuno-oncology company focused on bispecific antibodies. Previously, Ms. Toledano served as executive vice president of corporate development at Sorrento Therapeutics. From 2012-2016, Ms. Toledano served as head of healthcare investment banking at MLV & Co. (acquired by B. Riley FBR & Co.). Prior to joining MLV, Ms. Toledano served on the management team at Royalty Pharma. Ms. Toledano started her career in Israel where she led the Life Sciences Corporate Finance group at Ernst & Young (Israel) from 1998 to 2003. Ms. Toledano holds a Bachelor of Arts in economics from Tufts University and a Master of Business Administration in finance and entrepreneurship from the NYU Stern School of Business.
Dr. Tyle is currently the executive vice president of research and development at Lexicon Pharmaceuticals, a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for people with serious, chronic conditions. Prior to joining Lexicon, Dr. Tyle was a member of the executive management team at Osmotica Pharmaceuticals where he served as president, chief executive officer and a member of the board of directors. Dr. Tyle has more than 30 years of pharmaceutical industry experience and has held a series of other senior leadership and executive positions where he has advanced new medical device and drug candidate pipelines to commercial success.
In addition to the board appointments, Alberto Gabizon, M.D., Ph.D., co-founder of LipoMedix, will now serve as president of the company and will continue to lead the scientific, technological and clinical activities.
LipoMedix is a development-stage privately held company focused on the development of an innovative, safe and effective cancer therapy based on liposome delivery.
The Company was established to advance the pharmaceutical and clinical development of a patented 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 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 of Promitil and scientific founder of LipoMedix is Prof. Alberto Gabizon of the Hebrew University – Shaare Zedek Medical Center. Dr. Gabizon is also 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.
Promitil® is an innovative chemotherapeutic agent with distinct advantages over conventional anticancer agents that have adverse side effects and lack selective delivery to cancer affected sites. This innovative and breakthrough technology has successfully completed phase 1A and 1B studies and will enable cancer patients to receive safer therapy with a more potent anti-tumor effect.
Safe Harbor Statement
This press release contains forward-looking statements. These statements relate to future events or the company’s future financial performance. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "expect", "plan", "anticipate", "believe", "estimate", "predict", "potential" or "continue", the negative of such terms, or other comparable terminology. These statements are only predictions. Actual events or results may differ materially from those in the forward-looking statements as a 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 representation by the company, or any other person, that such forward-looking statements will be achieved. The business and operations of the company are subject to substantial risks which increase the uncertainty 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.
Lipomedix Pharmaceuticals has been awarded the SME Horizon 2020 Phase 1 grant for the project: Promitil® - a new ‘smart’ nanomedicine for cancer chemo-radiotherapy. (July 1, 2019)
Lipomedix Pharmaceuticals Ltd. announces the FDA clearance of its IND application to launch a randomized Phase 2b clinical trial of Promitil for the treatment of patients with previously treated metastatic colorectal cancer (Oct 2018).
Lipomedix Pharmaceuticals Ltd. announces the Israeli Ministry of Health clearance to launch a Phase 1b clinical trial of Promitil in combination with external beam radiotherapy in patients with advanced cancer requiring palliative radiotherapy for inoperable primary tumors or metastatic disease. The study (Liporad-18) will be launched soon and conducted by investigators in two Medical Centers in Israel (Nov 2018).
September 2018: Lipomedix received the approval of a new USPT Patent Application (#10,080,807) for the combined use of Promitil with other chemotherapy entitled "Combination Chemotherapy Comprising a Liposomal Prodrug of Mitomycin C"
April 2018: Lipomedix received the approval of a new USPT Patent Application (#9937261) for the combined use of Promitil with Radiotherapy entitled “Combination Therapy Comprising a Liposomal Prodrug of Mitomycin C and Radiotherapy”
July-2016: News release from UNC-Chapel Hill Cancer Center on a joint paper with Lipomedix on animal studies with Promitil and radiotherapy (http://unclineberger.org/news/wang-radiation)
May 2016: Lipomedix received a 2 million shekel grant from the Israel Chief Scientist Office for the funding of the project “Development of Promitil a pegylated liposomal MMC- prodrug”
Dr. Alberto Gabizon, President and Chief Scientist of Lipomedix, lectured at 12th European and Global Summit for Nanomedicine (CLINAM 2020) in Basel, Switzerland, October 26-28, 2020, on “Pharmacokinetic and Clinical Correlations of Pegylated Liposomal Mitomycin?c Prodrug (Promitil) in Colorectal Cancer Patients” (http://conference.clinam.org/).
Dr. Alberto Gabizon, President and Chief Scientist of Lipomedix, lectured at the Liposome Research Days 2019 Conference in Sapporo, Hokkaido , Japan, September 15-18, 2019 (http://www.knt.co.jp/ec/2019/LRD2019/index.html) on "Promitil® - a lipidic prodrug of mitomycin c in liposomes From bench to bedside"
Poster entitled “Clinical and pharmacokinetic study with a lipidic prodrug of mitomycin-c entrapped in liposomes in metastatic colorectal cancer patients” presented at the American Association for Cancer Research (AACR), annual meeting, Monday Apr 1, 2019 8:00 AM - 12:00 PM, Atlanta, Georgia, US
Poster entitled “Liposome co-encapsulation of doxorubicin and a prodrug of mitomycin-c for pharmacological optimization of combination chemotherapy” presented at the International Workshop on Clinical Pharmacology of Anticancer Drugs (ICPAD) meeting, November 8-9, 2018, Amsterdam, the Netherlands
Poster entitled “A dual drug formulation of pegylated liposomes with co-encapsulated doxorubicin and mitomycin c lipid-based prodrug for chemotherapy of cancer” presented at the Israel Controlled Research Society meeting, October 7-9, 2018, Maalot, Israel
Dr. Alberto Gabizon, CEO and Chief Scientist of Lipomedix, lectured at the 3rd Global Bioequivalence Harmonization Initiative Conference which took place in Amsterdam, April 12-13, 2018 (http://www.eufeps.org/conferences/3rd_GBHI) on "Liposome-based therapeutics: Impact of formulation on pharmacokinetics and pharmacodynamics"
Poster entitled “A Multidrug Formulation of Pegylated Liposomes with Co-Encapsulated Alendronate, Doxorubicin, and Mitomycin-C Lipid–Based Prodrug for Chemo-Immunotherapy of Cancer” presented at the ICRS meeting, September 14-16, 2016, Maalot, Israel
Poster entitled “A Phase 1B Study of Pegylated Liposomal Mitomycin-C Prodrug with or without Capecitabine and Bevacizumab in Third Line Chemotherapy of Colorectal Cancer” presented at the ESMO meeting, October 10-13, 2016, Copenhagen, Denmark
Poster entitled “Pharmacologic studies of a prodrug of mitomycin C in pegylated liposomes (Promitil®)” presented at Nano Israel Conference, February 22-23, Tel Aviv University, Israel
Lipomedix is seeking additional funding from private investors or investment groups for advancing the clinical development of Promitil®, and for further developing its pipeline. Prospective investors are invited to meet with the Company’s management team to discuss an investment in the Company.