At the present, a high potential of epigallocatechin-3-gallate (EGCG) as a new preventive and therapeutic agent in oncol. and several other indications is well established.EGCG exerts its antitumor activity through induction of cell cycle arrest and apoptosis, inhibition of tumor angiogenesis, migration and metastasis due to its ability to interact with multiple targets in cancer cell.Unfortunately, very low oral bioavailability of EGCG prevents its efficient development as novel medicine.In this work, we have developed a polymer based nano-formulation of EGCG that significantly improved its oral bioavailability by increasing systemic exposure of the compound by about 8-fold.This formulation comprises a well-known inactive ingredient non-ionic block copolymer Pluronic F127 that has recently been successfully used to increase bioavailability of another promising phytonutrient, 3,3'-diindolylmethane.The pharmacokinetic parameters established in the present study revealed that AUC and Cmax of the new formulation dosed at 500 mg/kg were 578.5 ± 73.8 μg·h/mL and 49.3 ± 2.9 μg/mL, while in the case of control EGCG administered in the equivalent dose AUC and Cmax were 72.9 ± 14.7 μg·h/mL, and 10.7 ± 1.1 μg/mL.

10 May 2010·Journal of Controlled ReleaseQ1 · MEDICINE

Effects of pluronic and doxorubicin on drug uptake, cellular metabolism, apoptosis and tumor inhibition in animal models of MDR cancers

Q1 · MEDICINE

Article

Author: Anna M. Brynskikh ; Valery Yu Alakhov ; Howard E. Gendelman ; Yili Li ; Nan Gong ; Elena V. Batrakova ; Alexander V. Kabanov ; R. Lee Mosley ; Shu Li ; Amit K. Sharma ; Michael Boska

Cancer chemotherapy is believed to be impeded by multidrug resistance (MDR). Pluronic (triblock copolymers of poly(ethylene oxide) (PEO) and poly(propylene oxide) (PPO), PEO-b-PPO-b-PEO) were previously shown to sensitize MDR tumors to antineoplastic agents. This study uses animal models of Lewis lung carcinoma (3LL-M27) and T-lymphocytic leukemia (P388/ADR and P388) derived solid tumors to delineate mechanisms of sensitization of MDR tumors by Pluronic P85 (P85) in vivo. First, non-invasive single photon emission computed tomography (SPECT) and tumor tissue radioactivity sampling demonstrate that intravenous co-administration of P85 with a Pgp substrate, 99Tc-sestamibi, greatly increases the tumor uptake of this substrate in the MDR tumors. Second, 31P magnetic resonance spectroscopy (31P-MRS) in live animals and tumor tissue sampling for ATP suggest that P85 and doxorubicin (Dox) formulations induce pronounced ATP depletion in MDR tumors. Third, these formulations are shown to increase tumor apoptosis in vivo by terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay and reverse transcription polymerase chain reaction (RT-PCR) for caspases 8 and 9. Altogether, formulation of Dox with P85 results in increased inhibition of the growth solid tumors in mice and represents novel and promising strategy for therapy of drug resistant cancers.

18 Feb 2010·Journal of Pharmacy and PharmacologyQ3 · MEDICINE

Pluronic block copolymers and Pluronic poly(acrylic acid) microgels in oral delivery of megestrol acetate

Q3 · MEDICINE

Article

Author: Hatton, T Alan ; Patel, Kishore ; Kabanov, Alexander ; Pietrzynski, Grzegorz ; Bromberg, Lev ; Alakhov, Valery

AbstractSeveral Pluronic-based formulations were studied in-vitro and in a rat model with respect to the release and bioavailability of megestrol acetate (MA) after oral administration. It was demonstrated that an aqueous, micellar formulation comprising a mixture of a hydrophobic (L61) and a hydrophilic (F127) Pluronic copolymer, significantly enhanced the bioavailability of MA administered orally at relatively low doses (1–7 mg kg−1). Pluronic-based microgels (spherical gel particles of sub-millimetre size) were introduced as MA vehicles. The microgels comprised a cross-linked network of poly(acrylic acid) onto which the Pluronic chains were covalently attached. Microgels of Pluronic L92 and poly(acrylic acid) fabricated into tablet dosage forms exhibited dramatically lowered MA initial burst release. The MA release was pH-dependent owing to the pH sensitivity of the microgel swelling, with the drug retained by the microgel at pH 1.8 and released slowly at pH 6.8. In the rat model, a significant increase in MA bioavailability was observed when the microgel-formulated MA was administered orally at a high dose of 10 mg kg−1, owing to the enhanced retention of the microgel. The study of the microgel passage through the gastrointestinal tract demonstrated the microgel retention characteristic of a very high molecular weight polymer and the absence of any systemic absorption of the polymer.

News (Medical) associated with Supratek Pharma, Inc.

01 Apr 2008

·www.biospace.com

Supratek Pharma Inc.'s Lead Compound SP1049C is Granted Orphan Drug Designation for the Treatment of Gastric Cancer

MONTREAL, April 1 /PRNewswire/ - Supratek Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SP1049C for the treatment of gastric cancer. Orphan drug refers to a product that is intended for use in a disease or condition that affects fewer than 200,000 individuals in the United States. According to the US National Cancer Institute it is estimated that 21,500 new cases of gastric cancer will be diagnosed in USA in 2008. Throughout the world, however, gastric cancer is the second leading cause of cancer-related deaths. Last year Supratek Pharma obtained FDA clearance for its Investigational New Drug application for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract. Recently Supratek has also reached an agreement with the FDA for the design of SP1049C pivotal Phase III study protocol under the Special Protocol Assessment process. A randomized Phase III pivotal clinical trial will compare SP1049C plus Best Supportive Care (BSC) versus BSC alone for the treatment of patients with metastatic adenocarcinoma of esophagus, gastroesophageal junction and stomach who have failed adjuvant or 1st or 2nd line chemotherapy. Supratek Pharma will direct the clinical development program. Oleg Romar, President and Chief Executive Officer, said, "Acquiring an orphan drug designation in gastric cancer is a welcome milestone for the SP1049C program". "Orphan drug designation provides multiple incentives for Supratek Pharma to continue its development of SP1049C for metastatic adenocarcinoma of the upper gastrointestinal tract. Our experience to date with SP1049C has been very encouraging and we look forward to the initiation of our Phase III pivotal clinical trial", added Dr. Christopher E. Newman, Vice-President and Chief Medical Officer of Supratek. About SP1049C ------------- SP1049C, Supratek's proprietary lead anticancer drug candidate, is a Biotransport(TM) nano-composition of block copolymers and one of the most potent cytotoxic drugs, doxorubicin. In pre-clinical and clinical development, SP1049C has been shown to have a strong activity and a novel mechanism of action against chemoresistant tumors, in which conventional chemotherapeutics are inactive. In 2005 SP1049C has also obtained an orphan drug designation from the FDA for the treatment of esophageal carcinoma. About Supratek Pharma Inc. -------------------------- Supratek Pharma is an emerging pharmaceutical company focused on the treatment of drug resistant and metastatic cancers. The company has seven clinical-stage proprietary products in its pipeline. The next product in line for clinical development is SP-MET-X1. It is based on the Company's potential breakthrough discovery of a new biochemical pathway and target consistently involved in metastasis formation and cancer progression. SP-MET-X1, the first drug developed in this new therapeutic class. Late-stage metastatic cancers account for the majority of cancer deaths and represent one of the major unmet medical needs world-wide. CONTACT: Dr. Christopher E. Newman, Vice-President and Chief Medical Officer, Supratek Pharma Inc., Phone: (514) 849-6094, e-mail: chris.newman@supratek.com

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

SP-1017 ( TYRP2 )	Melanoma More	Preclinical
SP1063C	Neoplasms More	Preclinical
SP-MET-1 ( S100A4 )	Breast Cancer More	Discontinued
AM-F9	Neoplasms More	Discontinued
SP-1062C-O	Colorectal Cancer More	Pending

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